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    Clinical Trial Results:
    Coagulopathy during surgery for the repair of Extent 4 Thoraco-Abdominal Aortic Aneurysms - feasibility study of the use of Fibrinogen Concentrate by infusion in place of Fresh Frozen Plasma.

    Summary
    EudraCT number
    		 2009-016709-41
    Trial protocol
    		 GB  
    Global end of trial date
    31 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Aug 2021
    First version publication date
    19 Aug 2021
    Other versions
    Summary report(s)
    		 Journal

    Trial information

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    Trial identification
    Sponsor protocol code
    FIB692
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00994045
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ACCORD (University of Edinburgh and NHS Lothian)
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Dr Alastair Nimmo, NHS Lothian, +44 0131 242 3224, a.nimmo@ed.ac.uk
    Scientific contact
    Dr Alastair Nimmo, NHS Lothian, +44 0131 242 3224, a.nimmo@ed.ac.uk
    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
    01 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the pattern of coagulation abnormalities in both groups (fibrinogen group and Fresh Frozen Plasma group).
    Protection of trial subjects
    This single-centre study was approved by a research ethics committee, and clinical trial authorisation was granted by the Medicines and Healthcare products Regulatory Agency (MHRA). Written informed consent was obtained from all participants.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2010
    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
    United Kingdom: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    3
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between June 2010 and August 2013, twenty-three patients were assessed for enrolment in the study of whom 20 completed the study (10 in each group). Three patients were excluded: taking warfarin (n = 1); declined to participate (n = 1); research staff unavailable (n = 1).

    Pre-assignment
    Screening details
    		 This was a small, single site pilot study. The study did not require the collection of information about patients screened for eligibility.

    Period 1
    Period 1 title
    Baseline (overall trial) (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
    		 Fresh frozen plasma (FFP)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fresh Frozen Plasma (FFP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The FFP group received FFP at an initial rate of 15 ml.kg-1.h-1 (approximately 40 mg.kg-1.h-1 of fibrinogen).

    Arm title
    		 Fibrinogen concentrate
    Arm description
    		 Fibrinogen concentrate is derived from pooled human plasma which is purified, treated to inactivate pathogens and freeze dried. It may be stored at room temperature in the operating room and then dissolved in sterile water when required.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fibrinogen concentrate
    Investigational medicinal product code
    BT524
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fibrinogen concentrate at 40 mg.kg-1.h-1. Infusion rates were doubled, left unchanged or halved according to subsequent FIBTEM results. The infusions were stopped if FIBTEM A10 was ≥ 8 mm and there was no significant ongoing bleeding.

    Number of subjects in period 1
    		Fresh frozen plasma (FFP) Fibrinogen concentrate
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline (overall trial)
    Reporting group description
    		 -

    Reporting group values
    		 Baseline (overall trial) Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 17 17
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Fresh frozen plasma (FFP)
    Reporting group description
    		 -

    Reporting group title
    Fibrinogen concentrate
    Reporting group description
    		 Fibrinogen concentrate is derived from pooled human plasma which is purified, treated to inactivate pathogens and freeze dried. It may be stored at room temperature in the operating room and then dissolved in sterile water when required.

    Primary: Allogeneic blood components

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    End point title
    		 Allogeneic blood components
    End point description
    End point type
    Primary
    End point timeframe
    During surgery and up to 24 h postoperatively.
    End point values
    		 Fresh frozen plasma (FFP) Fibrinogen concentrate
    Number of subjects analysed
    10
    10
    Units: ml
        median (inter-quartile range (Q1-Q3))
    22.5 (2 to 41)
    4.5 (0 to 17)
    Statistical analysis title
    		 Allogeneic blood components
    Comparison groups
    Fibrinogen concentrate v Fresh frozen plasma (FFP)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.011
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Randomisation to 24 hours post surgery.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not applicable
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: There were no adverse events including non-serious adverse events.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Mar 2010
    Increase in volume of blood taken from each patient to allow all the necessary clotting tests to be performed. Blood taken at each sampling point will increase from 15mls to 22.5mls and max total will increase from 180mls to 270 mls. Modification of pharmacy label that will be applied to study drug. Drug label now states that drug must be stored at below 25 degrees & do not freeze.

    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/30467829
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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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