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    Clinical Trial Results:
    Rivaroxaban and PCC: Prothrombin Complex Concentrate in patients with bleeding complications related to Rivaroxaban

    Summary
    EudraCT number
    		 2013-004484-31
    Trial protocol
    		 AT  
    Global end of trial date
    21 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2021
    First version publication date
    10 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Riva-PCC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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 Allg. u.l Chirurg. Intensivmedizin, 0043 51250424635, bettina.schenk@i-med.ac.at
    Scientific contact
    Projektmanagement, Medizinische Universität Innsbruck / Univ.-Klinik für Allg. u.l Chirurg. Intensivmedizin, 0043 51250424635, 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
    26 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment of effective reversal of Rivaroxaban (Xarelto) with Prothrombin Complex Concentrate (Beriplex)
    Protection of trial subjects
    Blood samples were drawn from an already implemented line, if applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Aug 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
    Austria: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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
    10
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at the medical University of Innsbruck, Austria from 19.08.2014 (first patient first visit) until 21.10.2016 (last patient last visit).

    Pre-assignment
    Screening details
    		 Patients were screened according to the in- and exclusion criteria.

    Period 1
    Period 1 title
    Visit 2
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Patients after PCC treatment
    Arm description
    		 Thrombin generation after treatment with Prothrombin Complex Concentrate (PCC)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prothrombin Complex Concentrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 IU per kg Body Weight. If bleeding did not stop, the dose was repeated.

    Number of subjects in period 1
    		Patients after PCC treatment
    Started
    14
    Completed
    14
    Period 2
    Period 2 title
    Overall Trial
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment with PCC
    Arm description
    		 All patients included received 25 IU/kg Body Weight Prothrombin Complex Concentrate (PCC). If bleeding did not stop, the dose was repeated.
    Arm type
    		 Treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Treatment with PCC
    Started
    14
    Completed
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Visit 2
    Reporting group description
    		 -

    Reporting group values
    		 Visit 2 Total
    Number of subjects
    		 14 14
    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)
    		 10 10
        From 65-84 years
    		 2 2
        85 years and over
    		 2 2
    Age continuous
    Units: years
        median (full range (min-max))
    		 80 (47 to 96) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 9 9

    End points

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    End points reporting groups
    Reporting group title
    Patients after PCC treatment
    Reporting group description
    		 Thrombin generation after treatment with Prothrombin Complex Concentrate (PCC)
    Reporting group title
    Treatment with PCC
    Reporting group description
    		 All patients included received 25 IU/kg Body Weight Prothrombin Complex Concentrate (PCC). If bleeding did not stop, the dose was repeated.

    Subject analysis set title
    Period 2: 1 hour after IMP administration
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all study participants

    Primary: difference in thrombin generation between V1 and V2

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    End point title
    		 difference in thrombin generation between V1 and V2
    End point description
    End point type
    Primary
    End point timeframe
    V1 - prior to treatment with PCC V2 - 10 minutes after the end of PCC administration
    End point values
    		 Treatment with PCC Patients after PCC treatment
    Number of subjects analysed
    14 [1]
    14 [2]
    Units: milliextinction(s)
        arithmetic mean (standard deviation)
    316 ( 75 )
    524 ( 94 )
    Notes
    [1] - Before treatment with PCC (Baseline)
    [2] - After treatment with PCC (Visit 2)
    Statistical analysis title
    		 Statistical assessment of primary endpoint
    Comparison groups
    Treatment with PCC v Patients after PCC treatment
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - Intra-Population analysis (before treatment versus after treatment)

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    inclusion until +7 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Since these were critically ill patients the non-serious AEs are too many to list here. In total 10 Serious Adverse Events were reported (Abdominal sepsis, Septic shock, multiple organ failure, sepsis, lower respiratory tract and lung infections, Stroke, Heart failure (NOS), Haemorrhage intracranial, Metastases to central nervous system, Peripheral artery stent insertion.) Three patients died within 30 days after treatment and no death was related to the IMP.

    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/29344007
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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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