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    Clinical Trial Results:
    Bicentric clinical trial with in vitro experiments to assess the effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia

    Summary
    EudraCT number
    		 2012-004087-22
    Trial protocol
    		 AT  
    Global end of trial date
    28 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Nov 2016
    First version publication date
    18 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FiT2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01955811
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Innsbruck
    Sponsor organisation address
    Anichstr. 35, Innsbruck, Austria, 6020
    Public contact
    Projektmanagement, Medizinische Universität Innsbruck / Univ.-Klinik für Allgem. und Chirurgische Intensivmedizin, +43 51250480604, bettina.schenk@i-med.ac.at
    Scientific contact
    Projektmanagement, Medizinische Universität Innsbruck / Univ.-Klinik für Allgem. und Chirurgische Intensivmedizin, +43 51250480604, bettina.schenk@i-med.ac.at
    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
    28 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the difference in maximum clot firmness (MCF) in ROTEM ExTEM® between blood samples after in vitro spiking and compared to those blood samples obtained from the same patients after platelet-transfusion.
    Protection of trial subjects
    Blood was drawn from an already implemented line.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jan 2013
    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
    Austria: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    34
    From 65 to 84 years
    59
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		  Patient with the clinical need for platelet transfusion  Age 18-85 years

    Period 1
    Period 1 title
    Baseline V2 (1 hour after PT)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Platelet transfusion
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    platelet concentrate
    Investigational medicinal product code
    PT
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1-2 units (250 - 500 ml)

    Arm title
    		 Fibrinogen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fibrinogen Concentrate
    Investigational medicinal product code
    F1
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection, Concentrate and solvent for solution for infusion
    Routes of administration
    In vitro use
    Dosage and administration details
    50,100,200 and 400 mg/kg body weight

    Number of subjects in period 1
    		Platelet transfusion Fibrinogen
    Started
    96
    96
    Completed
    96
    96
    Period 2
    Period 2 title
    Baseline (before PT)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fibrinogen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fibrinogen Concentrate
    Investigational medicinal product code
    F1
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection, Concentrate and solvent for solution for infusion
    Routes of administration
    In vitro use
    Dosage and administration details
    50,100,200 and 400 mg/kg body weight

    Arm title
    		 Platelet transfusion
    Arm description
    		 platelet transfusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    platelet concentrate
    Investigational medicinal product code
    PT
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1-2 units (250 - 500 ml)

    Number of subjects in period 2
    		Fibrinogen Platelet transfusion
    Started
    96
    96
    Completed
    96
    96

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline V2 (1 hour after PT)
    Reporting group description
    		 -

    Reporting group values
    		 Baseline V2 (1 hour after PT) Total
    Number of subjects
    		 96 96
    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
        Adults (18-64 years)
    		 34 34
        From 65-84 years
    		 59 59
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 75 75

    End points

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    End points reporting groups
    Reporting group title
    Platelet transfusion
    Reporting group description
    		 -

    Reporting group title
    Fibrinogen
    Reporting group description
    		 -
    Reporting group title
    Fibrinogen
    Reporting group description
    		 -

    Reporting group title
    Platelet transfusion
    Reporting group description
    		 platelet transfusion

    Primary: EXTEM MCF

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    End point title
    		 EXTEM MCF
    End point description
    End point type
    Primary
    End point timeframe
    Blood samples from V2 (1 hour after platelet transfusion) are compared to blood samples from V1 (before platelet transfusion) spiked with various amounts of human fibrinogen concentrate.
    End point values
    		 Platelet transfusion Fibrinogen Fibrinogen Platelet transfusion
    Number of subjects analysed
    96
    96
    96
    96
    Units: mm
        arithmetic mean (standard deviation)
    49 ± 9
    53 ± 9
    44 ± 9
    58 ± 9
    Statistical analysis title
    		 Wilcoxon signed rank test
    Comparison groups
    Fibrinogen v Platelet transfusion
    Number of subjects included in analysis
    192
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.95
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    JAN/2013-AUG/2014
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Patient Population
    Reporting group description
    		 -

    Serious adverse events
    		 Patient Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 96 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Patient Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 96 (1.04%)
    General disorders and administration site conditions
    Pain
    Additional description: Patient suffered from pain in the shoulder.
         subjects affected / exposed
    1 / 96 (1.04%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2013
    addition of confocal microscopy, adaption of fibrinogen values
    14 Jun 2013
    adaption of time period and fibrinogen concentration

    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.
    A limitation of the study is that fibrinogen addition was performed ex vivo and that a significant proportion of patients (24%) received fibrinogen concentrate in addition to PT which potentially influences results from V2 Baseline (1 h after PT)
    For support, Contact us.
    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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