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    Clinical Trial Results:
    A prospective randomized pilot trial on safety and feasibility of Argatroban as anticoagulant in patients with extracorporeal membrane oxygenation (ECMO)

    Summary
    EudraCT number
    		 2021-001456-34
    Trial protocol
    		 AT  
    Global end of trial date
    07 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Sep 2024
    First version publication date
    25 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ArgatrobanECMO_1.2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria, 1090
    Public contact
    Department of Medicine I, ICU 13i2, Medical University of Vienna, +43 14040044570,
    Scientific contact
    Department of Medicine I, ICU 13i2, Medical University of Vienna, +43 14040044570,
    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
    06 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • Safety of Argatroban as anticoagulant in ECMO
    Protection of trial subjects
    Subjects may prematurely discontinue from the study at any time. Premature discontinuation from the study means that the subject did not undergo an end of study examination as planned per protocol. Subjects must be withdrawn under the following circumstances: • at their own request • if the Investigator feels it would not be in the best interest of the subject to continue (e.g. severe bleeding, severe thrombosis, ongoing difficulties to reach target values, need for major surgery) • if the subject violates conditions laid out in the consent form / information sheet or disregards instructions by the study personal • Switch to argatroban: • confirmed HIT (following 4Ts score and PF4-antibody testing)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    27
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 40
    Number of subjects completed
    		 40

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Argatroban
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Argatroban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Intravenous use
    Dosage and administration details
    Starting dose: 0.2µg/kg/min, titration according to target range

    Arm title
    		 Unfractionated Heparin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Unfractionated Heparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Intravenous use
    Dosage and administration details
    According to anticoagulation target

    Number of subjects in period 1
    		Argatroban Unfractionated Heparin
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 40 40
    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)
    		 27 27
        From 65-84 years
    		 13 13
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 59 (51 to 66) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 33 33
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline Data

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    40
    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)
    27
        From 65-84 years
    13
        85 years and over
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    59 (51 to 66)
    Gender categorical
    Units: Subjects
        Female
    7
        Male
    33

    End points

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

    Reporting group title
    Unfractionated Heparin
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline Data

    Primary: Safety and Efficacy

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    End point title
    		 Safety and Efficacy
    End point description
    Combined endpoint of clinically relevant bleeding or thromboembolism
    End point type
    Primary
    End point timeframe
    Inclusion until End of Study
    End point values
    		 Argatroban Unfractionated Heparin Full analysis
    Number of subjects analysed
    20
    20
    40
    Units: % of patients
    30
    25
    28
    Statistical analysis title
    		 Pearson’s Chi-squared test
    Comparison groups
    Argatroban v Unfractionated Heparin
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Inclusion until End of Study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    unexpected adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 unexpected adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 unexpected adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 40 (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 unexpected serious or non-serious adverse events were observed during the study

    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
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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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