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    Clinical Trial Results:
    A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.

    Summary
    EudraCT number
    		 2016-004489-24
    Trial protocol
    		 BG   HU   DE   FR   SE   GB   RO  
    Global end of trial date
    20 May 2022

    Results information
    Results version number
    		 v1
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    IG1405
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03461406
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto Grifols, S.A
    Sponsor organisation address
    Can Guasch, 2, Parets del Vallès, Barcelona, Spain, 08150
    Public contact
    Department of Drug Development, Instituto Grifols, S.A., 34 935712000, IGregulatory.affairs@grifols.com
    Scientific contact
    Department of Drug Development, Instituto Grifols, S.A., 34 935712000, IGregulatory.affairs@grifols.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001598-PIP01-13
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of subjects achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).
    Protection of trial subjects
    Written Informed Consent Form (ICF) by the subject or a parent and/or legal guardian along with subject assent were obtained before any study specific procedure took place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 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 States: 28
    Country: Number of subjects enrolled
    Bulgaria: 26
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    Romania: 62
    Country: Number of subjects enrolled
    Serbia: 44
    Country: Number of subjects enrolled
    United Kingdom: 4
    Worldwide total number of subjects
    186
    EEA total number of subjects
    110
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    6
    Infants and toddlers (28 days-23 months)
    37
    Children (2-11 years)
    67
    Adolescents (12-17 years)
    76
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study at sites in the United States, Bulgaria, France, Hungary, Romania, Serbia, and United Kingdom, from 18 January 2019 (first subject enrolled to receive the study drug) to 20 May 2022 (last subject completed).

    Pre-assignment
    Screening details
    		 Paediatric subjects with excessive bleeding during surgery were randomized into 1: 1 ratio to receive FS Grifols and EVICEL. A total of 197 subjects were screened, out of which 186 subjects were randomized (Intent-to-treat population), 178 received study treatment (modified intent-to-treat population), 171 subjects completed the study.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fibrin Sealant Grifols
    Arm description
    		 Subjects topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FS Grifols
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal spray, solution
    Routes of administration
    Topical
    Dosage and administration details
    The FE Grifols solution was applied topically via drip or spray application.

    Arm title
    		 EVICEL
    Arm description
    		 Subjects topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EVICEL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal spray, solution
    Routes of administration
    Topical
    Dosage and administration details
    The EVICEL solution was applied topically via drip or spray application.

    Number of subjects in period 1
    		Fibrin Sealant Grifols EVICEL
    Started
    95
    91
    Parenchymous Surgery
    45 [1]
    43 [2]
    Soft Tissue Surgery
    45 [3]
    44 [4]
    Completed
    87
    84
    Not completed
    8
    7
         Consent withdrawn by subject
    -
    1
         Death
    1
    2
         Screen failure
    3
    1
         Lost to follow-up
    3
    -
         Reason not specified
    1
    3
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who underwent parenchymous surgery were included.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who underwent parenchymous surgery were included.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who underwent soft tissue surgery were included.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who underwent soft tissue surgery were included.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fibrin Sealant Grifols
    Reporting group description
    		 Subjects topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.

    Reporting group title
    EVICEL
    Reporting group description
    		 Subjects topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.

    Reporting group values
    		 Fibrin Sealant Grifols EVICEL Total
    Number of subjects
    		 95 91 186
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.43 ( 6.108 ) 8.84 ( 6.320 ) -
    Gender categorical
    Units: Subjects
        Female
    		 40 30 70
        Male
    		 55 61 116

    End points

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    End points reporting groups
    Reporting group title
    Fibrin Sealant Grifols
    Reporting group description
    		 Subjects topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.

    Reporting group title
    EVICEL
    Reporting group description
    		 Subjects topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.

    Primary: Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start (T4)

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    End point title
    		 Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start (T4)
    End point description
    Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator’s (surgeon’s) judgment, so that the surgical closure of the exposed field could begin. Modified ITT (mITT) population included all subjects in the ITT population who meet the intra-operative enrollment criteria, and thus treated with any amount of investigational product (IP). Overall number analysed are the number of participants with haemostasis by 4 minutes.
    End point type
    Primary
    End point timeframe
    From start of treatment until 4 minutes after treatment start (Day 1)
    End point values
    		 Fibrin Sealant Grifols EVICEL
    Number of subjects analysed
    91
    87
    Units: percentage of subjects
    number (not applicable)
        Parenchymous
    100.0
    100.0
        Soft Tissue
    93.3
    90.9
    Statistical analysis title
    		 Hemostasis by 4 Minutes (Parenchymous)
    Comparison groups
    Fibrin Sealant Grifols v EVICEL
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative risk
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.09
    Statistical analysis title
    		 Hemostasis by 4 Minutes (Soft Tissue)
    Comparison groups
    Fibrin Sealant Grifols v EVICEL
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative risk
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.16

    Secondary: Cumulative Proportion of Subjects Achieving Hemostasis at the TBS by the 7 Minutes After Treatment Start (T7)

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    End point title
    		 Cumulative Proportion of Subjects Achieving Hemostasis at the TBS by the 7 Minutes After Treatment Start (T7)
    End point description
    Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator’s (surgeon’s) judgment, so that the surgical closure of the exposed field could begin. The cumulative percentage of subjects achieving hemostasis at the TBS by the time points of T7 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or Grade 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure. Modified ITT (mITT) population included all subjects in the ITT population who meet the intra-operative enrollment criteria, and thus treated with any amount of investigational product (IP).
    End point type
    Secondary
    End point timeframe
    From start of treatment to 7 minutes after start of treatment (Day 1)
    End point values
    		 Fibrin Sealant Grifols EVICEL
    Number of subjects analysed
    91
    87
    Units: percentage of subjects
    number (not applicable)
        Parenchymous
    100.0
    100.0
        Soft tissue
    100.0
    100.0
    Statistical analysis title
    		 Hemostasis by 7 Minutes (Parenchymous)
    Comparison groups
    Fibrin Sealant Grifols v EVICEL
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative risk
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.09
    Statistical analysis title
    		 Hemostasis by 7 Minutes (Soft tissue)
    Comparison groups
    Fibrin Sealant Grifols v EVICEL
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative risk
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.09

    Secondary: Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10)

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    End point title
    		 Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10)
    End point description
    Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator’s (surgeon’s) judgment, so that the surgical closure of the exposed field could begin. The cumulative percentage of subjects achieving hemostasis at the TBS by the time points of T10 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or Grade 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure. Modified ITT (mITT) population included all subjects in the ITT population who meet the intra-operative enrollment criteria, and thus treated with any amount of investigational product (IP).
    End point type
    Secondary
    End point timeframe
    From start of treatment to 10 minutes after start of treatment (Day 1)
    End point values
    		 Fibrin Sealant Grifols EVICEL
    Number of subjects analysed
    91
    87
    Units: percentage of subjects
    number (not applicable)
        Parenchymous
    97.8
    100.0
        Soft tissue
    100.0
    100.0
    Statistical analysis title
    		 Hemostasis by 10 Minutes (Parenchymous)
    Comparison groups
    Fibrin Sealant Grifols v EVICEL
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative risk
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.02
    Statistical analysis title
    		 Hemostasis by 10 Minutes (Soft tissue)
    Comparison groups
    Fibrin Sealant Grifols v EVICEL
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative risk
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.09

    Secondary: Prevalence of Treatment Failures

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    End point title
    		 Prevalence of Treatment Failures
    End point description
    Subjects were considered treatment failures if there is a. persistent bleeding at the TBS beyond T4 b. Grade 3 or Grade 4 breakthrough bleeding from the TBS that jeopardizes subject safety according to the investigator’s judgment at any moment during the 10-minute observational period and until TClosure c. Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure, or use of study treatment at the TBS beyond T4 and until TClosure d. Rebleeding (Grade ≥1) at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure. Modified ITT (mITT) population included all subjects in the ITT population who meet the intra-operative enrollment criteria, and thus treated with any amount of investigational product (IP).
    End point type
    Secondary
    End point timeframe
    From start of treatment up to 10 minutes after start of treatment and until the time of completion of surgical closure (Day 1)
    End point values
    		 Fibrin Sealant Grifols EVICEL
    Number of subjects analysed
    91
    87
    Units: Subjects
        Parenchymous
    0
    0
        Soft Tissue
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing informed consent form through the final study visit (30 ± 7 days post operative)
    Adverse event reporting additional description
    The Safety population included all subjects who receive any amount of IP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Fibrin Sealant Grifols
    Reporting group description
    		 Subjects received FS Grifols, which consists of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.

    Reporting group title
    EVICEL
    Reporting group description
    		 Subjects received EVICEL, which consists of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.

    Serious adverse events
    		 Fibrin Sealant Grifols EVICEL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 91 (8.79%)
    9 / 87 (10.34%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    1
    2
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (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
    Pulmonary embolism
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Respiratory failure
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (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
    		 Fibrin Sealant Grifols EVICEL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 91 (21.98%)
    13 / 87 (14.94%)
    Investigations
    Blood magnesium decreased
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 87 (1.15%)
         occurrences all number
    1
    1
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Platelet count increased
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Mechanical ventilation complication
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Procedural pain
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Procedural vomiting
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Wound complication
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Wound dehiscence
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 87 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 87 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 91 (2.20%)
    3 / 87 (3.45%)
         occurrences all number
    2
    3
    General disorders and administration site conditions
    Generalised oedema
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 91 (0.00%)
    5 / 87 (5.75%)
         occurrences all number
    0
    6
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 87 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Melaena
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 87 (2.30%)
         occurrences all number
    1
    2
    Vomiting
         subjects affected / exposed
    5 / 91 (5.49%)
    3 / 87 (3.45%)
         occurrences all number
    5
    3
    Reproductive system and breast disorders
    Acquired hydrocele
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Bronchospasm
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 87 (1.15%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Pleural effusion
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Pneumothorax
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Postoperative abscess
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Wound infection
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Decreased appetite
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 May 2019
    The purpose of the amendment was to revise to describe the modifications made to the FS Grifols container and packaging and revise to describe the modified procedure for the spray application because the original applicator was replaced. The new applicator is a Dual Applicator tip, which does not require gas pressure and can be used for both drip and spray applications of the IP.
    06 Nov 2019
    The purpose of the amendment was to update the number of subjects allowed to enroll into the study. To update to clarify that subjects participating or planning to participate in any other study will not be allowed to enroll in this study. To revise to clarify the amount of IP allowed for each age group and to correct the recommended psi for EVICEL application.
    02 Nov 2021
    The purpose of the amendment was to update to allow enrollment of preterm (up to gestational age <37 week) and term newborn infants (0 to 27 days) undergoing emergency (non-elective) surgery, per FDA advice. To revise to allow for flexibility in enrollment if hepatic surgeries are less than 50%. To update number of subjects planned in case of under or over enrollment. To update to further define and clarify the demographic information to be recorded and to clarify all Screening and to updated to describe FDA regulations and guidance for recording race information.
    11 Nov 2021
    The purpose of the amendment was a administrative change to remove incorrect headers.

    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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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