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    Clinical Trial Results:
    A pragmatic pilot randomised phase II controlled trial of Prothrombin Complex Concentrates (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are Undergoing Heart Surgery (PROPHESY)

    Summary
    EudraCT number
    		 2018-003041-41
    Trial protocol
    		 GB  
    Global end of trial date
    29 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Nov 2020
    First version publication date
    11 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    012507
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03715348
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Dr Mays Jawad, Queen Mary University of London, +44 020 7882 7252, research.governance@qmul.ac.uk
    Scientific contact
    Dr Laura Green, Barts Health NHS Trust and NHSBT, +44 0208 957 2756, laura.green27@nhs.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the recruitment rate – defined as the proportion of participants who consent to the randomised study out of all eligible patients, and the proportion who are randomised and receive intervention out of consenting participants .
    Protection of trial subjects
    Patients who were not randomised to study intervention were treated as per standard care. Patients who were randomised to receive study intervention were treated as per standard care following one dose of the intervention they were randomised to. Patients were free to withdraw from the study at any time without giving reasons and without prejudicing his/her further treatment. Safety events were regularly reviewed by an independent Data Monitoring Committee, who advised the investigators if there were any safety concerns.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 134
    Worldwide total number of subjects
    134
    EEA total number of subjects
    134
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    53
    From 65 to 84 years
    77
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment began on 28/02/2019 and ended on 28/10/2019.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 134
    Number of subjects completed
    		 134

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fresh Frozen Plasma (FFP)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fresh Frozen Plasma (FFP)
    Investigational medicinal product code
    Other name
    FFP
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A 15mL/Kg dose of FFP was used which was rounded up to the following: - 3 units if <=60kg - 4 units if 61 to 90 kg - 5 units if >90 kg FFP must be administered by intravenous infusion after thawing, using an infusion set, over 5-20 min per unit. There is no maximum allowed dose for FFP. If bleeding continues, after administration of the first dose of FFP, patient will continue to receive standard care, and this may require further FFP transfusion. FFP will be stored at ≤-25°C for up to 36 months. Prior to use, FFP requires thawing at 37°C (between 33°C-37°C is acceptable) for 20 minutes in a waterbath or other equipment designed for the purpose, within a vacuum-sealed overwrap bag according to a validated procedure. Once thawed, FFP must not be refrozen and should be transfused as soon as possible. Transfusion of FFP should be completed within 4 hours of issue out of a controlled temperature environment. Administration of FFP should be by ABO-blood group compatibility.

    Arm title
    		 Prothrombin Complex Concentrate (PCC)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prothrombin Complex Concentrate (PCC)
    Investigational medicinal product code
    Other name
    PCC, Octaplex
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Octaplex is presented as a powder and comes in two different package sizes: 500 IU and 1000 IU. The following dose schedule was used: <=60 kg 500 IU (1 vial) 61 – 90 kg 1000 IU (2 vials) >90 kg 1,500 IU (3 vials) Octaplex will be administered intravenously at a slow speed: Initially 1 mL per minute, not faster than 2-3 mL per minute will be administered. If bleeding continues after administration of the first dose of PCC, patient will continue to receive standard care, and this does not include PCC. Therefore, no further PCC will be administered to patient. Octaplex should be stored below 25°C for up to 3 years, and in its original package in order to protect from light.After reconstitution the solution must be used immediately. Please refer to SmPC for instructions for reconstitution and infusion.

    Arm title
    		 Not randomised
    Arm description
    		 Patient did not bleed during or within 24 hours of surgery and was not randomised to receive either FFP or PCC
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Fresh Frozen Plasma (FFP) Prothrombin Complex Concentrate (PCC) Not randomised
    Started
    25
    25
    84
    Completed
    25
    25
    84

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fresh Frozen Plasma (FFP)
    Reporting group description
    		 -

    Reporting group title
    Prothrombin Complex Concentrate (PCC)
    Reporting group description
    		 -

    Reporting group title
    Not randomised
    Reporting group description
    		 Patient did not bleed during or within 24 hours of surgery and was not randomised to receive either FFP or PCC

    Reporting group values
    		 Fresh Frozen Plasma (FFP) Prothrombin Complex Concentrate (PCC) Not randomised Total
    Number of subjects
    		 25 25 84 134
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 66 (57 to 74) 69 (63 to 73) 67.5 (57 to 75.5) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9 31 49
        Male
    		 16 16 53 85
    Race
    Units: Subjects
        White
    		 20 21 66 107
        Asian
    		 1 1 6 8
        African
    		 1 0 4 5
        Mixed
    		 0 0 1 1
        Unknown/Not reported
    		 3 3 7 13
    Diabetes mellitus
    Units: Subjects
        Non-diabetic
    		 19 19 66 104
        Diabetic
    		 6 6 13 25
        Unknown
    		 0 0 5 5
    Hypertension
    Units: Subjects
        non-Hypertensive
    		 12 6 29 47
        Hypertensive
    		 13 19 50 82
        Unknown
    		 0 0 5 5
    Angina
    History of angina
    Units: Subjects
        No
    		 19 19 67 105
        Yes
    		 6 6 12 24
        Unknown
    		 0 0 5 5
    Previous PCI
    Units: Subjects
        No
    		 23 22 77 122
        Yes
    		 2 3 2 7
        Unknown
    		 0 0 5 5
    Previous cardiac Surgery
    Units: Subjects
        No
    		 24 23 75 122
        Yes
    		 1 2 4 7
        Unknown
    		 0 0 5 5
    Type of surgery
    Units: Subjects
        Elective surgery
    		 20 19 71 110
        Non-elective Surgery
    		 5 6 8 19
        Unknown
    		 0 0 5 5
    Procedure
    Units: Subjects
        Valve only
    		 7 5 34 46
        Major aortic only
    		 0 2 3 5
        CABG + valve
    		 5 6 17 28
        complex/combined procedures
    		 13 12 25 50
        Unknown
    		 0 0 5 5
    Antiplatelet use
    Units: Subjects
        No
    		 18 18 78 114
        Yes
    		 7 7 1 15
        Unknown
    		 0 0 5 5
    Anticoagulant use
    Units: Subjects
        No
    		 18 16 72 106
        Yes
    		 7 9 7 23
        Unknown
    		 0 0 5 5
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 80.5 ( 16.2 ) 76.1 ( 19.7 ) 78 ( 17.3 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 168.1 ( 10.7 ) 167.3 ( 9.5 ) 169.3 ( 10.2 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 28.5 ( 5.3 ) 27.0 ( 5.8 ) 27.1 ( 5.8 ) -
    EuroSCORE
    Units: unit
        median (inter-quartile range (Q1-Q3))
    		 2.94 (1.83 to 4.86) 3.73 (2.25 to 5.86) 2.19 (1.26 to 3.94) -
    EQ5D index score
    Units: unit
        median (inter-quartile range (Q1-Q3))
    		 0.9 (0.75 to 0.96) 0.9 (0.78 to 1) 0.86 (0.7 to 0.94) -
    Hemoglobin
    laboratory test at screening
    Units: g/L
        median (inter-quartile range (Q1-Q3))
    		 135 (121 to 145) 130 (124 to 141) 133 (130 to 135) -
    Platelet count
    laboratory test at screening
    Units: Thousand/uL
        median (inter-quartile range (Q1-Q3))
    		 227 (184 to 271) 239 (194 to 259) 227 (184 to 271) -
    PT
    Prothrombin time at screening
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    		 11 (11 to 12) 11 (11 to 12) 11 (10.8 to 11.8) -
    APTT
    Activated partial thromboplastin time at screening
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    		 25 (23 to 27) 27 (25 to 29) 26 (24 to 28) -
    Subject analysis sets

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    includes only those patients who completed the treatment originally allocated

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    includes all patients as originally allocated after randomisation

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all patients who received FFP or PCC, in order to obtain data on event rates in both groups to help estimate the sample size for the large trial

    Subject analysis set title
    Eligible patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients who met the eligibility criteria for the trial. The number in the analysis set is 180 with 134 of these consenting.

    Subject analysis set title
    Consenting patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All eligible patients who consent

    Subject analysis set title
    Non-consenting patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Proportion of eligible patients who do not consent to enter trial

    Subject analysis set title
    FFP per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Freash Frozen Plasma (FFP) per protocol analysis set

    Subject analysis set title
    PCC per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PCC per protocol analysis set

    Subject analysis sets values
    		 Per protocol Intention-to-treat Safety population Eligible patients Consenting patients Non-consenting patients FFP per protocol PCC per protocol
    Number of subjects
    42
    50
    55
    134
    134
    46
    21
    21
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    68 (57 to 73)
    68 (60 to 74)
    68 (56 to 74)
    68 (57 to 74)
    63 (54 to 73)
    69 (63 to 73)
    Gender categorical
    Units: Subjects
        Female
    16
    18
    19
    49
    8
    8
        Male
    26
    32
    36
    85
    13
    13
    Race
    Units: Subjects
        White
    34
    41
    45
    107
    107
    16
    18
        Asian
    2
    2
    2
    85
    85
    1
    1
        African
    1
    1
    1
    5
    5
    1
    0
        Mixed
    0
    0
    0
    1
    1
    0
    0
        Unknown/Not reported
    5
    6
    7
    59
    13
    46
    3
    2
    Diabetes mellitus
    Units: Subjects
        Non-diabetic
    33
    38
    44
    104
    104
    17
    16
        Diabetic
    9
    12
    11
    25
    25
    4
    5
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Hypertension
    Units: Subjects
        non-Hypertensive
    16
    18
    19
    47
    47
    10
    6
        Hypertensive
    26
    32
    36
    82
    82
    11
    15
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Angina
    History of angina
    Units: Subjects
        No
    32
    38
    42
    105
    105
    16
    16
        Yes
    10
    12
    13
    24
    24
    5
    5
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Previous PCI
    Units: Subjects
        No
    38
    45
    50
    122
    122
    19
    19
        Yes
    4
    5
    5
    7
    7
    2
    2
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Previous cardiac Surgery
    Units: Subjects
        No
    39
    47
    51
    122
    122
    20
    19
        Yes
    3
    3
    4
    7
    7
    1
    2
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Type of surgery
    Units: Subjects
        Elective surgery
    31
    39
    43
    110
    110
    16
    15
        Non-elective Surgery
    11
    11
    12
    19
    19
    5
    6
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Procedure
    Units: Subjects
        Valve only
    9
    12
    12
    46
    46
    4
    5
        Major aortic only
    2
    2
    3
    5
    5
    0
    2
        CABG + valve
    10
    11
    11
    28
    28
    5
    5
        complex/combined procedures
    21
    25
    29
    50
    50
    12
    9
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Antiplatelet use
    Units: Subjects
        No
    30
    36
    42
    114
    114
    15
    15
        Yes
    12
    14
    13
    15
    15
    6
    6
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Anticoagulant use
    Units: Subjects
        No
    38
    34
    38
    106
    106
    15
    13
        Yes
    14
    16
    17
    23
    23
    6
    8
        Unknown
    0
    0
    0
    51
    5
    46
    0
    0
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    78.0 ( 17.7 )
    78.3 ( 18.0 )
    77.3 ( 17.6 )
    ( )
    78.1 ( 17.5 )
    ( )
    79.8 ( 16.8 )
    76.2 ( 18.7 )
    Height
    Units: cm
        arithmetic mean (standard deviation)
    167.6 ( 10.0 )
    167.7 ( 10.1 )
    168.5 ( 10.3 )
    ( )
    168.7 ( 10.1 )
    ( )
    168.6 ( 11.0 )
    166.6 ( 9.1 )
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.7 ( 5.3 )
    27.8 ( 5.6 )
    27.1 ( 5.4 )
    ( )
    27.4 ( 5.4 )
    ( )
    28.0 ( 5.3 )
    27.3 ( 5.4 )
    EuroSCORE
    Units: unit
        median (inter-quartile range (Q1-Q3))
    3.51 (1.94 to 5.46)
    3.42 (1.83 to 5.46)
    3.47 (1.83 to 5.86)
    2.50 (1.54 to 4.40)
    3.3 (1.94 to 5.46)
    3.73 (2.25 to 5.28)
    EQ5D index score
    Units: unit
        median (inter-quartile range (Q1-Q3))
    0.87 (0.75 to 0.95)
    0.90 (0.76 to 1)
    0.87 (0.75 to 0.95)
    0.87 (0.70 to 0.95)
    0.90 (0.72 to 0.98)
    0.87 (0.78 to 0.94)
    Hemoglobin
    laboratory test at screening
    Units: g/L
        median (inter-quartile range (Q1-Q3))
    133 (123 to 142)
    133 (123 to 145)
    132 (122 to 142.5)
    133 (123 to 144)
    135 (123 to 145)
    130 (124 to 140)
    Platelet count
    laboratory test at screening
    Units: Thousand/uL
        median (inter-quartile range (Q1-Q3))
    241 (194 to 283)
    238 (187 to 271)
    227 (175.5 to 264.5)
    229 (185 to 271)
    261 (172 to 300)
    240.5 (201 to 258.5)
    PT
    Prothrombin time at screening
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    11.25 (10.8 to 11.9)
    11.35 (10.8 to 12)
    11.2 (10.8 to 11.9)
    11.1 (10.8 to 11.9)
    10.8 (10.7 to 12.4)
    11.4 (10.9 to 11.9)
    APTT
    Activated partial thromboplastin time at screening
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    26 (24 to 28)
    26 (24 to 28)
    26 (24 to 28)
    26 (24 to 28)
    25 (23 to 27)
    26 (25 to 28)

    End points

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    End points reporting groups
    Reporting group title
    Fresh Frozen Plasma (FFP)
    Reporting group description
    		 -

    Reporting group title
    Prothrombin Complex Concentrate (PCC)
    Reporting group description
    		 -

    Reporting group title
    Not randomised
    Reporting group description
    		 Patient did not bleed during or within 24 hours of surgery and was not randomised to receive either FFP or PCC

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    includes only those patients who completed the treatment originally allocated

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    includes all patients as originally allocated after randomisation

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all patients who received FFP or PCC, in order to obtain data on event rates in both groups to help estimate the sample size for the large trial

    Subject analysis set title
    Eligible patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients who met the eligibility criteria for the trial. The number in the analysis set is 180 with 134 of these consenting.

    Subject analysis set title
    Consenting patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All eligible patients who consent

    Subject analysis set title
    Non-consenting patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Proportion of eligible patients who do not consent to enter trial

    Subject analysis set title
    FFP per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Freash Frozen Plasma (FFP) per protocol analysis set

    Subject analysis set title
    PCC per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PCC per protocol analysis set

    Primary: Proportion of eligible participants who consent

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    End point title
    		 Proportion of eligible participants who consent [1]
    End point description
    End point type
    Primary
    End point timeframe
    8 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a single point estimate not a comparison between groups. The software does not allow entry of the confidence interval when there is only one group. The proportion (95% CI) for this endpoint is 0.744 (0.674, 0.806)
    End point values
    		 Eligible patients
    Number of subjects analysed
    180
    Units: subjects
        Non-consenting
    46
        Consenting
    134
    No statistical analyses for this end point

    Primary: Proportion of participants who are randomised and receive intervention within 24 hours of surgery, out of all consenting participants

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    End point title
    		 Proportion of participants who are randomised and receive intervention within 24 hours of surgery, out of all consenting participants [2]
    End point description
    End point type
    Primary
    End point timeframe
    within 24 hours following surgery
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a single point estimate not a comparison between groups. The software does not allow entry of the confidence interval when there is only one group. The proportion (95% CI) for this endpoint is 0.351 (0.270, 0.438)
    End point values
    		 Consenting patients
    Number of subjects analysed
    134
    Units: subjects
        Not randomised and receiving intervention
    87
        Randomised and receiving intervention
    47
    No statistical analyses for this end point

    Secondary: Time to administration of study drug (PCC) or control (FFP) to patient

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    End point title
    		 Time to administration of study drug (PCC) or control (FFP) to patient
    End point description
    Defined as time in minutes from telephoning laboratory to first administration to patient
    End point type
    Secondary
    End point timeframe
    within 24 hours following surgery
    End point values
    		 Fresh Frozen Plasma (FFP) Prothrombin Complex Concentrate (PCC) Not randomised
    Number of subjects analysed
    22 [3]
    25
    0 [4]
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    72 (40 to 114)
    63 (36 to 108)
    ( to )
    Notes
    [3] - 3 patients in the FFP group did not receive intervention
    [4] - These patients consented but did not bleed and so did not enter the randomised part of the study.
    No statistical analyses for this end point

    Secondary: Proportion of patients for whom clinical outcome data were collected up to 90 days, or death, whichever occur first

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    End point title
    		 Proportion of patients for whom clinical outcome data were collected up to 90 days, or death, whichever occur first
    End point description
    End point type
    Secondary
    End point timeframe
    90 days following surgery
    End point values
    		 Intention-to-treat
    Number of subjects analysed
    50
    Units: subjects
        Lost to follow-up
    4
        90 day Follow-up
    46
    No statistical analyses for this end point

    Secondary: Proportion of patients who bleed and are randomised within 24 hours of surgery

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    End point title
    		 Proportion of patients who bleed and are randomised within 24 hours of surgery
    End point description
    End point type
    Secondary
    End point timeframe
    within 24 hours following surgery
    End point values
    		 Consenting patients
    Number of subjects analysed
    134
    Units: subjects
        Not randomised
    84
        Randomised
    50
    No statistical analyses for this end point

    Secondary: Proportion of consenting patients who are not randomised within 24 hours of surgery

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    End point title
    		 Proportion of consenting patients who are not randomised within 24 hours of surgery
    End point description
    End point type
    Secondary
    End point timeframe
    within 24 hours following surgery
    End point values
    		 Consenting patients
    Number of subjects analysed
    134
    Units: subjects
        Not randomised
    84
        Randomised
    50
    No statistical analyses for this end point

    Secondary: Proportion of consenting participants who bleed and receive a protocol intervention within 24 hours of surgery (whether or not they are randomised)

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    End point title
    		 Proportion of consenting participants who bleed and receive a protocol intervention within 24 hours of surgery (whether or not they are randomised)
    End point description
    End point type
    Secondary
    End point timeframe
    within 24 hours following surgery
    End point values
    		 Safety population
    Number of subjects analysed
    134
    Units: subjects
        No intervention
    79
        Received study intervention
    55
    No statistical analyses for this end point

    Secondary: Proportion of patients for whom timing of administration, and completion of intervention(s) were documented

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    End point title
    		 Proportion of patients for whom timing of administration, and completion of intervention(s) were documented
    End point description
    End point type
    Secondary
    End point timeframe
    within 24 hours following surgery
    End point values
    		 Intention-to-treat
    Number of subjects analysed
    50
    Units: subjects
        Data incomplete
    3
        Data complete
    47
    No statistical analyses for this end point

    Secondary: Proportion of patients where there was protocol adherence

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    End point title
    		 Proportion of patients where there was protocol adherence
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Intention-to-treat
    Number of subjects analysed
    50
    Units: subjects
        Protocol deviation
    8
        Protocol adherance
    42
    No statistical analyses for this end point

    Secondary: Reasons for non-participation of eligible patients

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    End point title
    		 Reasons for non-participation of eligible patients
    End point description
    End point type
    Secondary
    End point timeframe
    Recruitment period
    End point values
    		 Eligible patients
    Number of subjects analysed
    180
    Units: 1.1
        Patient declined
    37
        Language barrieer
    6
        Partial sightedness
    1
        Procedure did not meet eligibility criteria
    1
        Clinician decision
    1
        Patient enrolled
    134
    No statistical analyses for this end point

    Secondary: Reasons for intervention non-compliance

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    End point title
    		 Reasons for intervention non-compliance
    End point description
    End point type
    Secondary
    End point timeframe
    within 24 hours following surgery
    End point values
    		 Per protocol
    Number of subjects analysed
    50
    Units: subjects
        Stopped bleeding before intervention
    3
        Already received FFP
    1
        Received treatment to which they were randomised
    46
    No statistical analyses for this end point

    Secondary: Proportion of patients who do not consent to intervention, but agree to consenting of their de- identified data for up to 24 hours after surgery

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    End point title
    		 Proportion of patients who do not consent to intervention, but agree to consenting of their de- identified data for up to 24 hours after surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Recruitment period
    End point values
    		 Non-consenting patients
    Number of subjects analysed
    46
    Units: subjects
        Not available
    46
    No statistical analyses for this end point

    Secondary: Change in PT from baseline to 1 hour

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    End point title
    		 Change in PT from baseline to 1 hour
    End point description
    Change in clotting factors from baseline to 1 hour
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    16
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    -4 (-6.1 to -2.1)
    -2.6 (-4.85 to -1.3)
    Statistical analysis title
    		 Change in PT from baseline to 1 hour
    Statistical analysis description
    Difference in change between groups and 95% CIs.
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.94
         upper limit
    		 3.94
    Notes
    [5] - Descriptive

    Secondary: Change in PT from baseline to 24 hours

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    End point title
    		 Change in PT from baseline to 24 hours
    End point description
    Difference between groups in change from baseline to 24 hours
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    -4.45 (-6.6 to -2.75)
    -3.9 (-6.1 to -1.9)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 4.5
    Notes
    [6] - Descriptive

    Secondary: Change in APTT from baseline to 1 hour

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    End point title
    		 Change in APTT from baseline to 1 hour
    End point description
    Change in clotting factors at 1 hour
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    15
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    -12.9 (-40.7 to -6.4)
    -4.2 (-16.8 to 0.1)
    Statistical analysis title
    		 Change in APPT from baseline to 1 hour
    Statistical analysis description
    Median change(95% CI)
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.2
         upper limit
    		 30.6
    Notes
    [7] - Descriptive

    Secondary: Change in APTT from baseline to 24 hours

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    End point title
    		 Change in APTT from baseline to 24 hours
    End point description
    Change in clotting factors at 24 hours
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    13
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    -30.55 (-49.4 to -7.1)
    -7.9 (-23.9 to -6.1)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    28.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 57.39
    Notes
    [8] - Descriptive

    Secondary: Change in fibrinogen at 1 hour

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    End point title
    		 Change in fibrinogen at 1 hour
    End point description
    Change in clotting factors at 1 hour
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: g/L
        median (inter-quartile range (Q1-Q3))
    0.34 (0.2 to 0.6)
    0.01 (-0.1 to 0.26)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.07
    Notes
    [9] - Descriptive

    Secondary: Change in fibrinogen at 24 hours

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    End point title
    		 Change in fibrinogen at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: g/L
        median (inter-quartile range (Q1-Q3))
    1.85 (1.19 to 2.57)
    1.7 (1.06 to 2.08)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.04
         upper limit
    		 0.8
    Notes
    [10] - Deacriptive

    Secondary: Change in D-Dimer at 1 hour

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    End point title
    		 Change in D-Dimer at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: mg/L FEU
        median (inter-quartile range (Q1-Q3))
    -0.13 (-0.93 to 0.05)
    -0.04 (-0.18 to 0.27)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    PCC per protocol v FFP per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.31
         upper limit
    		 0.49
    Notes
    [11] - Descriptive

    Secondary: Change in D-Dimer at 24 hours

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    End point title
    		 Change in D-Dimer at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: mg/L FEU
        median (inter-quartile range (Q1-Q3))
    -0.08 (-0.68 to -0.01)
    -0.04 (-0.36 to 0.05)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.6
    Notes
    [12] - Descriptive

    Secondary: Change in Factor II at 1 hour

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    End point title
    		 Change in Factor II at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    11.4 (4.5 to 16.3)
    22.4 (20.3 to 27.3)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.86
         upper limit
    		 19.14
    Notes
    [13] - Descriptive

    Secondary: Change in Factor II at 24 hours

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    End point title
    		 Change in Factor II at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    21.1 (3.55 to 28.8)
    21.45 (11.2 to 31.9)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.82
         upper limit
    		 13.82
    Notes
    [14] - Descriptive

    Secondary: Change in Factor V at 1 hour

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    End point title
    		 Change in Factor V at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    26.2 (12.8 to 40.3)
    0.3 (-2 to 6.6)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -25.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.4
         upper limit
    		 -13.4
    Notes
    [15] - Descriptive

    Secondary: Change in factor V at 24 hours

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    End point title
    		 Change in factor V at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    59.3 (28.2 to 82.25)
    33.45 (15.3 to 55.9)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.6
         upper limit
    		 13.6
    Notes
    [16] - Descriptive

    Secondary: Change in factor VII at 1 hour

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    End point title
    		 Change in factor VII at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    16.7 (8 to 28.2)
    16.4 (12.5 to 23.8)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.49
         upper limit
    		 9.89
    Notes
    [17] - Descriptive

    Secondary: Change in Factor VII at 24 hours

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    End point title
    		 Change in Factor VII at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    -4.55 (-10.7 to 17.5)
    8.2 (-14.1 to 13.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    11.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.65
         upper limit
    		 31.85

    Secondary: Change in Factor VIII at 1 hour

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    End point title
    		 Change in Factor VIII at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    8.4 (-14.3 to 40.8)
    1 (-7.3 to 31.7)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.09
         upper limit
    		 22.29

    Secondary: Change in Factor VIII at 24 hours

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    End point title
    		 Change in Factor VIII at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    106.1 (79.65 to 121.05)
    87.45 (57.1 to 127.4)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -10.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -60.8
         upper limit
    		 39.4

    Secondary: Change in Factor IX at 1 hour

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    End point title
    		 Change in Factor IX at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    7.2 (-8.6 to 24.9)
    14.9 (3.4 to 21)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.73
         upper limit
    		 26.13

    Secondary: Change in Factor IX at 24 hours

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    End point title
    		 Change in Factor IX at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    28.35 (6.5 to 40.2)
    27.1 (4 to 40.4)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    PCC per protocol v FFP per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.02
         upper limit
    		 23.42

    Secondary: Change in Factor X at 1 hour

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    End point title
    		 Change in Factor X at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    11.6 (4.8 to 18.1)
    20.9 (17.2 to 26.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    9.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 17.89

    Secondary: Change in Factor X at 24 hours

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    End point title
    		 Change in Factor X at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    22.25 (6.3 to 27)
    22.45 (9.3 to 29.8)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.5
         upper limit
    		 13.7

    Secondary: Change in Factor XI at 1 hour

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    End point title
    		 Change in Factor XI at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    8.4 (3.1 to 27.1)
    0 (-3.9 to 6.8)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.9
         upper limit
    		 4.1

    Secondary: Change in Factor XI at 24 hours

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    End point title
    		 Change in Factor XI at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    20.75 (9.4 to 38.3)
    5.65 (0 to 21.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -16.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.84
         upper limit
    		 3.04

    Secondary: Change in Factor XII at 1 hour

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    End point title
    		 Change in Factor XII at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: U/dL
        median (inter-quartile range (Q1-Q3))
    10.5 (1.5 to 17.4)
    -2.2 (-7.2 to 3.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -12.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.46
         upper limit
    		 -0.94

    Secondary: Change in Factor XII at 24 hours

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    End point title
    		 Change in Factor XII at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: U/dL
        median (inter-quartile range (Q1-Q3))
    21.5 (-0.5 to 32.7)
    10.75 (0.3 to 24.2)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -13.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.34
         upper limit
    		 8.14

    Secondary: Change in Factor XIII at 1 hour

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    End point title
    		 Change in Factor XIII at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    10.5 (2.7 to 19.1)
    -1.8 (-5.5 to 3.2)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -12.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.26
         upper limit
    		 -2.34

    Secondary: Change in Factor XIII at 24 hours

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    End point title
    		 Change in Factor XIII at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    7.05 (4.1 to 14.3)
    0.9 (-16.3 to 12.3)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    PCC per protocol v FFP per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.02
         upper limit
    		 5.82

    Secondary: Change in VWF antigen at 1 hour

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    End point title
    		 Change in VWF antigen at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    16
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    1.7 (-14.9 to 28.6)
    20.35 (-5.75 to 39)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    18.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.96
         upper limit
    		 49.76

    Secondary: Change in VWF antigen at 24 hours

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    End point title
    		 Change in VWF antigen at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    69.65 (5.45 to 119.25)
    83.95 (53.9 to 124.4)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    16.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.51
         upper limit
    		 74.71

    Secondary: Change in VWF activity at 1 hour

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    End point title
    		 Change in VWF activity at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    16
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    20.1 (-0.9 to 42.7)
    17.35 (-0.5 to 88.6)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.59
         upper limit
    		 52.59

    Secondary: Change in VWF activity at 24 hours

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    End point title
    		 Change in VWF activity at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    87.65 (29.55 to 129.7)
    101.6 (82.2 to 124.2)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -50.45
         upper limit
    		 69.85

    Secondary: Change in AT activity at 1 hour

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    End point title
    		 Change in AT activity at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    18
    16
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    9.9 (4.5 to 12.9)
    0.5 (-2 to 3.7)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.96
         upper limit
    		 -4.04

    Secondary: Change in AT activity at 24 hours

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    End point title
    		 Change in AT activity at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    22.25 (8.1 to 29.4)
    14.75 (4.7 to 18.1)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -7.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.34
         upper limit
    		 3.34

    Secondary: Change in PC activity at 1 hour

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    End point title
    		 Change in PC activity at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    11.2 (5.8 to 21)
    19.9 (9.1 to 29)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 18.12

    Secondary: Change in PC activity at 24 hours

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    End point title
    		 Change in PC activity at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    21.25 (14.05 to 36.65)
    18.85 (-0.2 to 33.8)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.55
         upper limit
    		 14.35

    Secondary: Change in TAT at 1 hour

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    End point title
    		 Change in TAT at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    16
    Units: µg/L
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0.3)
    0 (0 to 0.2)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.79
         upper limit
    		 3.79

    Secondary: Change in TAT at 24 hours

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    End point title
    		 Change in TAT at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    14
    13
    Units: µg/L
        median (inter-quartile range (Q1-Q3))
    -5 (-12.4 to 0)
    -2.4 (-12.1 to 0)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.85
         upper limit
    		 12.05

    Secondary: Change in HMWK at 1 hour

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    End point title
    		 Change in HMWK at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    15
    Units: U/dL
        median (inter-quartile range (Q1-Q3))
    -3.15 (-4.1 to 02)
    10.9 (-2.6 to 23.3)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.29
         upper limit
    		 24.29

    Secondary: Change in HMWK at 24 hours

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    End point title
    		 Change in HMWK at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    14
    12
    Units: U/dL
        median (inter-quartile range (Q1-Q3))
    6.3 (-7.9 to 21.4)
    14.6 (-9.75 to 24.45)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.3
         upper limit
    		 34.1

    Secondary: Change in PRK at 1 hour

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    End point title
    		 Change in PRK at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    15
    Units: U/dL
        median (inter-quartile range (Q1-Q3))
    10.3 (-2.85 to 18.1)
    -4 (-12 to 14.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.7
         upper limit
    		 0.9

    Secondary: Change in PRK at 24 hours

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    End point title
    		 Change in PRK at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    14
    12
    Units: U/dL
        median (inter-quartile range (Q1-Q3))
    5.55 (-6.4 to 25.7)
    -2.8 (-34.75 to 13.3)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -12.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.12
         upper limit
    		 19.52

    Secondary: Change in C1-inhibitor at 1 hour

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    End point title
    		 Change in C1-inhibitor at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    16
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    7.2 (-6.4 to 13.1)
    2.3 (-7.55 to 7.1)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.62
         upper limit
    		 4.82

    Secondary: Change in C1-inhibitor at 24 hours

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    End point title
    		 Change in C1-inhibitor at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    34.15 (8.1 to 45.95)
    24.2 (10.9 to 40.2)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.15
         upper limit
    		 19.95

    Secondary: change in a2-antiplasmin at 1 hour

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    End point title
    		 change in a2-antiplasmin at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    8.4 (4.2 to 16.7)
    -1 (-2.9 to 7.2)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -9.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.15
         upper limit
    		 -1.65

    Secondary: change in a2-antiplasmin at 24 hours

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    End point title
    		 change in a2-antiplasmin at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    34.85 (16.5 to 43.25)
    23.95 (6.3 to 36)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -11.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.82
         upper limit
    		 13.42

    Secondary: Change in plasminogen at 1 hour

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    End point title
    		 Change in plasminogen at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    17
    Units: U/dL
        median (inter-quartile range (Q1-Q3))
    6.7 (1.3 to 11.7)
    -1 (-4.2 to 1)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.31
         upper limit
    		 -2.09

    Secondary: Change in plasminogen at 24 hours

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    End point title
    		 Change in plasminogen at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    14
    Units: U/dL
        median (inter-quartile range (Q1-Q3))
    16.35 (8.25 to 22.85)
    2.6 (-3.8 to 10.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.05
         upper limit
    		 -2.15

    Secondary: Change in tPA:Ag activity at 1 hour

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    End point title
    		 Change in tPA:Ag activity at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    16
    Units: µg/L
        median (inter-quartile range (Q1-Q3))
    -0.3 (-1.7 to 1.1)
    0 (-1.35 to 1.1)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.7

    Secondary: Change in tPA:Ag at 24 hours

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    End point title
    		 Change in tPA:Ag at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    13
    Units: µg/L
        median (inter-quartile range (Q1-Q3))
    0.2 (-1.4 to 3.95)
    -1.5 (-3.4 to 0)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.36
         upper limit
    		 1.76

    Secondary: Change in Prothrombin F.1+2 at 1 hour

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    End point title
    		 Change in Prothrombin F.1+2 at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    16
    Units: pM
        median (inter-quartile range (Q1-Q3))
    13 (0 to 219.5)
    0 (-233.5 to 137)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    PCC per protocol v FFP per protocol
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -244.38
         upper limit
    		 192.38

    Secondary: Change in Prothrombin F.1+2 at 24 hours

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    End point title
    		 Change in Prothrombin F.1+2 at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    14
    13
    Units: pM
        median (inter-quartile range (Q1-Q3))
    -524.5 (-920 to -317)
    -651 (-934 to -398)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -153
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -542.95
         upper limit
    		 236.95

    Secondary: Change in PAP at 1 hour

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    End point title
    		 Change in PAP at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    18
    16
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    104 (-34 to 336)
    -54 (-139 to 38.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -157
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -386.64
         upper limit
    		 72.64

    Secondary: change in PAP at 24 hours

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    End point title
    		 change in PAP at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    15
    13
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    179 (-73 to 391)
    -49 (-220 to 320)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -228
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -593.96
         upper limit
    		 137.96

    Secondary: Change in TAFI at 1 hour

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    End point title
    		 Change in TAFI at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    19
    16
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    9 (3 to 16)
    4 (-1 to 7)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 1

    Secondary: Change in TAFI at 24 hours

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    End point title
    		 Change in TAFI at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    13
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    13 (7.5 to 21.5)
    8 (-2 to 11)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    PCC per protocol v FFP per protocol
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.96
         upper limit
    		 5.96

    Secondary: Change in thrombomodulin at 1 hour

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    End point title
    		 Change in thrombomodulin at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    18
    16
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    100 (30 to 524)
    183.5 (67 to 406.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    146
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -131.72
         upper limit
    		 423.72

    Secondary: Change in thrombomodulin at 24 hours

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    End point title
    		 Change in thrombomodulin at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    15
    13
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    38 (-67 to 251)
    70 (3 to 169)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -162.33
         upper limit
    		 226.33

    Secondary: Change in Tissue Factor at 1 hour

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    End point title
    		 Change in Tissue Factor at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    17
    16
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    0.8 (-0.7 to 8.4)
    0.05 (-2.05 to 1.35)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.79
         upper limit
    		 4.19

    Secondary: Change in Tissue Factor at 24 hours

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    End point title
    		 Change in Tissue Factor at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    15
    13
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    1 (-0.5 to 2.2)
    0 (-2.1 to 0.4)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.21
         upper limit
    		 1.21

    Secondary: Change in sEPCR at 1 hour

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    End point title
    		 Change in sEPCR at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    18
    16
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    0 (0 to 749)
    0 (-1319 to 713.5)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1129.98
         upper limit
    		 1129.98

    Secondary: Change in sEPCR at 24 hours

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    End point title
    		 Change in sEPCR at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    15
    13
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    0 (-1167 to 0)
    -362 (-2189 to 167)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    362
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2202.82
         upper limit
    		 1478.82

    Secondary: Change in TG-ETP at 1 hour

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    End point title
    		 Change in TG-ETP at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    17
    17
    Units: nM Thrombin
        median (inter-quartile range (Q1-Q3))
    350 (-237 to 667)
    159 (-352 to 714)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    191
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -765.84
         upper limit
    		 383.84

    Secondary: Change in TG-ETP at 24 hours

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    End point title
    		 Change in TG-ETP at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    14
    14
    Units: nM Thrombin
        median (inter-quartile range (Q1-Q3))
    581.5 (112 to 961)
    686 (116 to 1407)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -763.25
         upper limit
    		 817.25

    Secondary: Change in TG- Peak thrombin at 1 hour

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    End point title
    		 Change in TG- Peak thrombin at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    17
    17
    Units: nM Thrombin
        median (inter-quartile range (Q1-Q3))
    88 (-48 to 118)
    6 (-57 to 64)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -194.68
         upper limit
    		 30.68

    Secondary: Change in TG- Peak thrombin at 24 hours

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    End point title
    		 Change in TG- Peak thrombin at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    14
    14
    Units: nM Thrombin
        median (inter-quartile range (Q1-Q3))
    82.5 (-29 to 166)
    53 (-7 to 223)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -141.4
         upper limit
    		 113.4

    Secondary: Change in TG- lag time at 1 hour

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    End point title
    		 Change in TG- lag time at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    17
    17
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    -1.33 (-5.61 to 0.44)
    -0.45 (-0.88 to 0.33)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.51
         upper limit
    		 4.27

    Secondary: Change in TG - lag time at 24 hours

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    End point title
    		 Change in TG - lag time at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    14
    14
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    -1.69 (-5.61 to 1.11)
    0.34 (-0.22 to 2)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    2.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 6.31

    Secondary: Change in TG- time to peak at 1 hour

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    End point title
    		 Change in TG- time to peak at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    17
    17
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    -2.83 (-9.56 to 0.61)
    0.67 (-0.89 to 2)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    PCC per protocol v FFP per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 7.88

    Secondary: Change in TG- time to peak at 24 hours

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    End point title
    		 Change in TG- time to peak at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    14
    14
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    -3.44 (-9.33 to 1.89)
    1.11 (-0.67 to 3.22)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    4.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.97
         upper limit
    		 10.39

    Secondary: Change in Free PS antigen at 1 hour

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    End point title
    		 Change in Free PS antigen at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    18
    16
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    8.35 (4.4 to 11.7)
    13 (6.55 to 16.05)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    PCC per protocol v FFP per protocol
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 10.23

    Secondary: Change in Free PS antigen at 24 hours

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    End point title
    		 Change in Free PS antigen at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 FFP per protocol PCC per protocol
    Number of subjects analysed
    16
    13
    Units: IU/dL
        median (inter-quartile range (Q1-Q3))
    15.6 (-2.1 to 24.55)
    12.2 (4.6 to 19.3)
    Statistical analysis title
    		 Difference in change between treatment groups
    Comparison groups
    FFP per protocol v PCC per protocol
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.88
         upper limit
    		 10.68

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from one hour after receiving study intervention until 90 days following intervention or death, whichever occurs first.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Fresh Frozen Plasma (FFP) Safety population
    Reporting group description
    		 All consenting patients who bled and received FFP regardless of whether they were randomised.

    Reporting group title
    Prothrombin Complex Concentrate (PCC) Safety population
    Reporting group description
    		 All consenting patients who bled and received PCC regardless of whether they were randomised.

    Serious adverse events
    		 Fresh Frozen Plasma (FFP) Safety population Prothrombin Complex Concentrate (PCC) Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 26 (34.62%)
    5 / 29 (17.24%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    1
    Investigations
    Raised INR
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Lacunar infarction
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord ischaemia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute right ventricular failure
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Heart failure
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Multiorgan failure
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fresh Frozen Plasma (FFP) Safety population Prothrombin Complex Concentrate (PCC) Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 26 (80.77%)
    22 / 29 (75.86%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Thrombosis
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Thrombophlebitis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Haematoma
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Haemorrhage
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Tracheostomy
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 29 (10.34%)
         occurrences all number
    1
    3
    Cardiac pacemaker insertion
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Asthenia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    14 / 26 (53.85%)
    14 / 29 (48.28%)
         occurrences all number
    15
    15
    Atelectasis
         subjects affected / exposed
    5 / 26 (19.23%)
    2 / 29 (6.90%)
         occurrences all number
    5
    2
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Hypoxia
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Pneumothorax
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Respiratory failure
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 29 (10.34%)
         occurrences all number
    1
    3
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Transaminases increased
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Blood lactic acid increased
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Lactic acidosis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Thoracic cavity drainage
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    2
    Cardiac perforation
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    Pulmonary oedema
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Nervous system disorders
    Meningioma
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Seizure
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Eye disorders
    Microvascular cranial nerve palsy
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 26 (3.85%)
    5 / 29 (17.24%)
         occurrences all number
    1
    5
    Melaena
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Anuria
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Acute on chronic liver failure
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Polyuria
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Cholecystitis acute
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Sepsis
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Pneumonia
         subjects affected / exposed
    2 / 26 (7.69%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    Bacterial infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Enterococcus test positive
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    4 / 26 (15.38%)
    0 / 29 (0.00%)
         occurrences all number
    4
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Hypernatraemia
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Aug 2019
    Additional exclusion criteria (ECMO, any other reason clinician deems unsuitable), clarification of endpoints and analysis, qualitative research manual, updated IMP label
    06 Jan 2020
    Addition of a meeting at the end of the study where participants will be invited to hear study results and asked for their feedback on study recruitment procedures and outcome measures, to inform the large trial

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This is a feasibility/pilot study with the aim of determining the recruitment rate for a larger-scale trial and assessing trial procedures. It was not statistically powered to compare FFP and PCC in terms of effectiveness or safety.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31815658
    For support, Contact us.
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