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    Clinical Trial Results:
    Pharmacokinetics of intramuscular tranexamic acid in trauma patients: a clinical trial

    Summary
    EudraCT number
    		 2019-000898-23
    Trial protocol
    		 GB  
    Global end of trial date
    12 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jan 2021
    First version publication date
    14 Jan 2021
    Other versions
    Summary report(s)
    		 Trauma-INTACT publication
    Trauma-INTACT figures
    Trauma-INTACT supplementary table

    Trial information

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    Trial identification
    Sponsor protocol code
    2019/KEP/218
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03875937
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    London School of Hygiene and Tropical Medicine
    Sponsor organisation address
    Keppel Street, London, United Kingdom, WC1E 7HT
    Public contact
    Clinical Trials Unit, London School of Hygiene and Tropical Medicine, 0207 2994684, traumaim@Lshtm.ac.uk
    Scientific contact
    Clinical Trials Unit, London School of Hygiene and Tropical Medicine, 0207 2994684, traumaim@Lshtm.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
    30 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In an emergency situation, tranexamic acid is commonly administered intravenously, but this route might not always be feasible. If tranexamic acid injected intramuscularly is absorbed quickly, this route of administration of tranexamic acid might be an alternative to the intravenous route. We will determine how fast tranexamic acid is absorbed after intramuscular administration in bleeding trauma patients.
    Protection of trial subjects
    The trial was done in accordance with the good clinical practice guidelines by the International Conference on Harmonisation. The procedure at each site was approved by the relevant ethics committee and regulatory agencies. Consent was obtained from participants if their physical and mental capacity allowed (as judged by the treating clinician). If a participant was unable to give consent, proxy consent was obtained from a relative or representative. If a proxy was unavailable, then consent was waived. When consent was waived or given by a proxy, the participant was informed about the trial as soon as possible, and consent was obtained for ongoing data collection, if needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Sep 2019
    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: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    1
    Adults (18-64 years)
    20
    From 65 to 84 years
    6
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 The Trauma-INTACT trial enrolled 31 bleeding trauma patients aged 16 and older in 2 hospitals in the UK (1 patient was withdrawn before trial treatment was given so is not included in the analysis). The first patient was randomised on 17/09/19 and the final patient on 07/02/20.

    Pre-assignment
    Screening details
    		 All adult (appear to be at least 16 years old) bleeding trauma patients, who have received 1 gram of intravenous tranexamic acid (TXA) and for whom a second dose of TXA is clinically indicated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Tranexamic acid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tranexamic Acid
    Investigational medicinal product code
    B02AA02
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Patients received two 5mL (0.5g each) intramuscular injections of tranexamic acid. (All patients had already received a loading dose of 1g IV tranexamic acid, as per clinical guidelines, before being enrolled in the trial)

    Number of subjects in period 1
    		Tranexamic acid
    Started
    30
    Completed
    30

    Baseline characteristics

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

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 1 1
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 6 6
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 26 26

    End points

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

    Primary: Serum concentration over time

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    End point title
    		 Serum concentration over time [1]
    End point description
    End point type
    Primary
    End point timeframe
    Within 4 minutes of administration of i.m. TXA
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See publication attached
    End point values
    		 Tranexamic acid
    Number of subjects analysed
    30
    Units: mg L-1
    5
    Attachments
    		 Trauma-INTACT figures
    No statistical analyses for this end point

    Primary: Serum concentration over time

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    End point title
    		 Serum concentration over time [2]
    End point description
    End point type
    Primary
    End point timeframe
    Within 11 minutes of i.m. TXA
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See publication attached
    End point values
    		 Tranexamic acid
    Number of subjects analysed
    30
    Units: mg L-1
    10
    Attachments
    		 Trauma-INTACT figures
    No statistical analyses for this end point

    Secondary: Local reactions at injection site

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    End point title
    		 Local reactions at injection site
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 7 days
    End point values
    		 Tranexamic acid
    Number of subjects analysed
    30
    Units: N/A
        Erythema
    2
        Induration and subcutaneous nodules
    4
        Bruising
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 7 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Tranexamic acid
    Reporting group description
    		 -

    Serious adverse events
    		 Tranexamic acid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    9
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tranexamic acid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    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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