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    Clinical Trial Results:
    Vasculopathic Injury and Plasma as Endothelial Rescue – OCTAplas trial

    Summary
    EudraCT number
    		 2014-000452-28
    Trial protocol
    		 DK  
    Global end of trial date
    24 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2022
    First version publication date
    21 Jan 2022
    Other versions
    Summary report(s)
    		 Article

    Trial information

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    Trial identification
    Sponsor protocol code
    VIPER-OCTA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02253082
    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
    31 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To conduct a pilot trial to assess the effects of OctaplasLG® on endothelial integrity, as compared to standard FFP, in a patient population experiencing severe endothelial dysfunction.
    Protection of trial subjects
    As the patients are admitted to the hospital, standard of care is provided to the patients. The excluding criteria prevent inclusion of patients not eligible for the trial.
    Background therapy
    		 Standard of care
    Evidence for comparator
    		 The comparator is FFP and i used as standard of care as coagulation factor replacement related to bleeding
    Actual start date of recruitment
    01 Apr 2014
    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: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    33
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From November 2014 to July 2016, 57 subjects (Intension-to-treat population) were randomized to obtain 44 evaluable patients. Included patients were admitted to Rigshospitalet, Copenhagen University Hospital, Denmark, undergoing emergency surgery for thoracic aortic dissection

    Pre-assignment
    Screening details
    		 Patients were screened upon admission to the hospital

    Pre-assignment period milestones
    Number of subjects started
    		 72 [1]
    Number of subjects completed
    		 57

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 1
    Reason: Number of subjects
    		 Exclusion criteria meet: 10
    Reason: Number of subjects
    		 Intervention not available: 1
    Reason: Number of subjects
    		 Missed inclusion: 3
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of 72 is the number of of patients screened. The number of 57 is the number of patients randomised and the number of 44 is the number of patients fulfilling per protocol and therefore the primary endpoint.
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Data analyst [2]
    Blinding implementation details
    research staff performed onsite randomization (1:1) by envelope opening. The randomization was done in a block size of 6; sequence and envelopes were generated and validated by 2 independent people otherwise not involved in the trial. Randomization was performed using Microsoft Excel software (Microsoft, Redmond, WA)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OctaplasLG
    Arm description
    		 Adminitration until bleeding control
    Arm type
    		 Experimental

    Investigational medicinal product name
    OctaplasLG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Administration until bleeding control

    Arm title
    		 Fresh frozen plasma (FFP)
    Arm description
    		 Plasma adminitration until bleeding control. This arm i standard of care.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    FFP
    Investigational medicinal product code
    Other name
    Fresh frozen plasma
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Administration until bleeding control

    Notes
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: the laboratory staff performing the biomarkers analyses and the statistician were blinded to the allocation.
    Number of subjects in period 1
    		OctaplasLG Fresh frozen plasma (FFP)
    Started
    29
    28
    Completed
    23
    21
    Not completed
    6
    7
         Physician decision
    1
    1
         Error in inclusion
    1
    -
         dead before 24 hours
    4
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 57 57
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adult (age 18 years or above)
    		 57 57
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 45 45

    End points

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    End points reporting groups
    Reporting group title
    OctaplasLG
    Reporting group description
    		 Adminitration until bleeding control

    Reporting group title
    Fresh frozen plasma (FFP)
    Reporting group description
    		 Plasma adminitration until bleeding control. This arm i standard of care.

    Primary: Endothelial derived biomarkers

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    End point title
    		 Endothelial derived biomarkers
    End point description
    The primary outcome measure was glycocalyx and endothelial injury as measured by plasma levels of endothelialderived biomarkers (syndecan-1, soluble thrombomodulin [sTM], soluble (s) E-selectin, sVE-cadherin) at24 hours after surgery compared to the baseline defined as 15 minutes before weaning from CPB
    End point type
    Primary
    End point timeframe
    24 hours
    End point values
    		 OctaplasLG Fresh frozen plasma (FFP)
    Number of subjects analysed
    23
    21
    Units: ng/ml
    median (inter-quartile range (Q1-Q3))
        Thrombomodulin
    3.5 (1.8 to 6)
    1.4 (0.3 to 4.1)
        Selectin
    8.4 (2.3 to 21.4)
    12.3 (-19.5 to 19.3)
        Cadherin
    372.0 (221.1 to 522.1)
    543.0 (223.6 to 686.3)
        Syndecan-1
    -67.6 (-76.1 to -45.5)
    -34.3 (-76.9 to -20.6)
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Fresh frozen plasma (FFP) v OctaplasLG
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Mortality

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    End point title
    		 Mortality
    End point description
    End point type
    Secondary
    End point timeframe
    Mortality at day 30 and day 90
    End point values
    		 OctaplasLG Fresh frozen plasma (FFP)
    Number of subjects analysed
    29
    28
    Units: number
        Day 30 mortality
    6
    7
    Statistical analysis title
    		 Secondary endpoint
    Comparison groups
    OctaplasLG v Fresh frozen plasma (FFP)
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.76
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For evaluation of safety, we followed severe adverse reactions, transfusion-associated ALI, and transfusion-associated cardiac overload in the first 30 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Octaplas
    Reporting group description
    		 Intervention arm Only SAE and SAR are recorded due to severly ill patients

    Reporting group title
    Standard FFP
    Reporting group description
    		 The control arm. Only SAE and SAR are recorded due to severly ill patients

    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: As these patients are severly ill only SAEs and SARs are recorded
    Serious adverse events
    		 Octaplas Standard FFP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 29 (27.59%)
    11 / 28 (39.29%)
         number of deaths (all causes)
    6
    7
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Ischaemia
         subjects affected / exposed
    3 / 29 (10.34%)
    4 / 28 (14.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion reaction
    Additional description: transfusion-associated circulatory overload (TACO)
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Transfusion
    Additional description: Need for blood transfusion above 2 RBC within 24 hours
         subjects affected / exposed
    4 / 29 (13.79%)
    5 / 28 (17.86%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Octaplas Standard FFP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 28 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29863610
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