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    Clinical Trial Results:
    Vasculopathic Injury and Plasma as Endothelial Rescue in septic shock (SEPSIS) trial

    Summary
    EudraCT number
    		 2016-000707-81
    Trial protocol
    		 DK  
    Global end of trial date
    04 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 May 2018
    First version publication date
    06 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VIPER-SEPSIS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02875236
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet, Section for Transfusion Medicine, Capitol Region Blood Bank
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, DK-2100
    Public contact
    Pär I. Johansson, Section for Transfusion Medicine, Capitol Region Blood Bank, 45 35452030, per.johansson@regionh.dk
    Scientific contact
    Pär I. Johansson, Section for Transfusion Medicine, Capitol Region Blood Bank, 45 35452030, per.johansson@regionh.dk
    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
    02 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Efficacy of octaplasLG® administration as compared to crystalloids (standard) in patients with septic shock
    Protection of trial subjects
    Patients are closely monitored during the trial. - Blood drawn only from already inserted catheter - WBC must be between 4,000-12,000/mm3 - TRALI/TACO and anaphylaxis are closely monitored
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    2
    From 65 to 84 years
    2
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients are recruited from ITA at Bispebjerg Hospital in the period from 29/8-2016 to 26/9-2016

    Pre-assignment
    Screening details
    		 Patients admitted to the ICU were screened for inclusion in the trial

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Octaplas
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    OctaplasLG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Resuscitation fluid to patient with septic shock. No fixed dosage. OctaplasLG is given at 200 ml interval until patient reach adequate volume resuscitation

    Arm title
    		 Ringer-acetat
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ringer-acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Resuscitation fluid to patient with septic shock. No fixed dosage. Ringer-acetate is given at 200 ml interval until patient reach adequate volume resuscitation

    Number of subjects in period 1
    		Octaplas Ringer-acetat
    Started
    2
    3
    Completed
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Octaplas
    Reporting group description
    		 -

    Reporting group title
    Ringer-acetat
    Reporting group description
    		 -

    Reporting group values
    		 Octaplas Ringer-acetat Total
    Number of subjects
    		 2 3 5
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 2 2
        From 65-84 years
    		 1 1 2
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 82 (78 to 85) 67 (60 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 3
        Male
    		 0 2 2
    Subject analysis sets

    Subject analysis set title
    Demographics
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Only five patients were included so the study was prematurely ended

    Subject analysis sets values
    		 Demographics
    Number of subjects
    5
    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)
    2
        From 65-84 years
    2
        85 years and over
    1
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    71 (60 to 85)
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    2

    End points

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    End points reporting groups
    Reporting group title
    Octaplas
    Reporting group description
    		 -

    Reporting group title
    Ringer-acetat
    Reporting group description
    		 -

    Subject analysis set title
    Demographics
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Only five patients were included so the study was prematurely ended

    Primary: Change in Microscan

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    End point title
    		 Change in Microscan [1]
    End point description
    Change in microvascular perfusion using microscan
    End point type
    Primary
    End point timeframe
    From baseline until 6h
    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: A this trial was premature ended with only 5 patients included an analysis of the primary endpoint were not performed
    End point values
    		 Octaplas Ringer-acetat
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: percentage
        number (not applicable)
    Notes
    [2] - Premature termination of the study therefore this analysis could not performed
    [3] - Premature termination of the study therefore this analysis could not performed
    No statistical analyses for this end point

    Primary: Change in biomarkers

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    End point title
    		 Change in biomarkers [4]
    End point description
    Change in biomarkers (sE-selectin, syndecan-1, thrombomodulin, sVE-cadherin, nucleosomes) indicative of endothelial activation and damage
    End point type
    Primary
    End point timeframe
    From baseline to 6h
    Notes
    [4] - 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: A this trial was premature ended with only 5 patients included an analysis of the primary endpoint were not performed
    End point values
    		 Octaplas Ringer-acetat
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: various
        number (not applicable)
    Notes
    [5] - Premature termination of the trial therefore this analysis was not performed
    [6] - Premature termination of the trial therefore this analysis was not performed
    No statistical analyses for this end point

    Secondary: Mortality

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    End point title
    		 Mortality
    End point description
    Number of patients dying within 90 days
    End point type
    Secondary
    End point timeframe
    Difference in 6h, 24h, 7, 30 and 90 days mortality
    End point values
    		 Octaplas Ringer-acetat
    Number of subjects analysed
    2
    3
    Units: Arbitary
    1
    3
    No statistical analyses for this end point

    Secondary: SAE

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    End point title
    		 SAE
    End point description
    Number of SAE reported until day 30
    End point type
    Secondary
    End point timeframe
    SAE reported until day 30
    End point values
    		 Octaplas Ringer-acetat
    Number of subjects analysed
    2
    3
    Units: number
    0
    0
    No statistical analyses for this end point

    Secondary: Days in ventilator

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    End point title
    		 Days in ventilator
    End point description
    Mean value of the numbers of days the patients were on ventilation
    End point type
    Secondary
    End point timeframe
    Days on ventilator until discharge or dead
    End point values
    		 Octaplas Ringer-acetat
    Number of subjects analysed
    2
    3
    Units: Number
    0
    3
    No statistical analyses for this end point

    Secondary: Length of stay in the ICU

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    End point title
    		 Length of stay in the ICU
    End point description
    Mean value of number of days the patients were admitted on the ICU
    End point type
    Secondary
    End point timeframe
    From baseline until discharge from the ICU or dead
    End point values
    		 Octaplas Ringer-acetat
    Number of subjects analysed
    2
    3
    Units: number
    4
    8
    No statistical analyses for this end point

    Secondary: Days on vasopressor

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    End point title
    		 Days on vasopressor
    End point description
    Mean value of number of days patients were on vasopressor treatment
    End point type
    Secondary
    End point timeframe
    Number of days on vasopressor until discharge or death
    End point values
    		 Octaplas Ringer-acetat
    Number of subjects analysed
    2
    3
    Units: Number
    2
    3
    No statistical analyses for this end point

    Secondary: Bleeding requirement above 2 RBC / day

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    End point title
    		 Bleeding requirement above 2 RBC / day
    End point description
    Number of patients in each group with bleeding requirement above 2 RBC /day
    End point type
    Secondary
    End point timeframe
    From baseline until 72h
    End point values
    		 Octaplas Ringer-acetat
    Number of subjects analysed
    2
    3
    Units: Number
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline until day 30
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    OctaplasLG
    Reporting group description
    		 -

    Reporting group title
    Ringer-Acetate
    Reporting group description
    		 -

    Serious adverse events
    		 OctaplasLG Ringer-Acetate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    1
    3
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 OctaplasLG Ringer-Acetate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse reaction were recorded during the study

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2016
    Removal of statistical analysis NIRS. This removal did not impact patient safety or resulted in any ethical considerations

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Nov 2016
    This trial was prematurely ended due to lack of patient. No safety concerns were observed during the trial
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    premature termination of the trial resulted in lack of patients included and therefore lack of statistical analysis
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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
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