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    Clinical Trial Results:
    STOP-MSU – Stopping haemorrhage with Tranexamic acid for hyperacute Onset Presentation including Mobile Stroke Units

    Summary
    EudraCT number
    		 2020-004746-10
    Trial protocol
    		 FI  
    Global end of trial date
    28 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2024
    First version publication date
    18 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NTA1702
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03385928
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Florey Institute of Neuroscience and Mental Health
    Sponsor organisation address
    245 Burgundy Street, Heidelberg, Australia, VIC 3084
    Public contact
    Michele Sallaberger, The Florey Institute of Neuroscience and Mental Health, 61 390357269, michele.sallaberger@florey.edu.au
    Scientific contact
    Michele Sallaberger, The Florey Institute of Neuroscience and Mental Health, 61 390357269, michele.sallaberger@florey.edu.au
    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
    19 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy and safety of administration of intravenous tranexamic acid in patients with intracerebral haemorrhage within 2 hours of onset.
    Protection of trial subjects
    Informed consent
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2017
    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
    Finland: 18
    Country: Number of subjects enrolled
    Australia: 145
    Country: Number of subjects enrolled
    Taiwan: 38
    Worldwide total number of subjects
    201
    EEA total number of subjects
    18
    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)
    201
    From 65 to 84 years
    0
    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
    		 202 [1]
    Number of subjects completed
    		 201

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    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: 1 patient withdrew consent
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic acid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    ATC B02AA02
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h

    Number of subjects in period 1
    		Tranexamic acid Placebo
    Started
    103
    98
    Completed
    103
    98
    Period 2
    Period 2 title
    24 hour
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic acid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    ATC B02AA02
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous 1 g over 10 min followed by 1 g over 8 h

    Number of subjects in period 2
    		Tranexamic acid Placebo
    Started
    103
    98
    Completed
    103
    98
    Period 3
    Period 3 title
    90 days
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic acid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    ATC B02AA02
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h

    Number of subjects in period 3
    		Tranexamic acid Placebo
    Started
    103
    98
    Completed
    103
    98

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Tranexamic acid Placebo Total
    Number of subjects
    		 103 98 201
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 65 (54 to 76) 67 (57 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 40 42 82
        Male
    		 63 56 119

    End points

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    End points reporting groups
    Reporting group title
    Tranexamic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Tranexamic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Tranexamic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Haematoma growth

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    End point title
    		 Haematoma growth
    End point description
    End point type
    Primary
    End point timeframe
    24 hours
    End point values
    		 Tranexamic acid Placebo
    Number of subjects analysed
    103
    98
    Units: Haematoma growth
    43
    37
    Statistical analysis title
    		 Primary outcome
    Comparison groups
    Tranexamic acid v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.19

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    90 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Tranexamic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    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: NA
    Serious adverse events
    		 Tranexamic acid Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 103 (21.36%)
    16 / 98 (16.33%)
         number of deaths (all causes)
    19
    15
         number of deaths resulting from adverse events
    Vascular disorders
    Major thromboembolic events
         subjects affected / exposed
    3 / 103 (2.91%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    19 / 103 (18.45%)
    15 / 98 (15.31%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 15
         deaths causally related to treatment / all
    0 / 19
    0 / 15
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Tranexamic acid Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 98 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2020
    Version 6.0, 15 October 2020

    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/38648814
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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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