Clinical Trial Results:
Pharmacokinetics of intramuscular tranexamic acid in trauma patients: a clinical trial
Summary
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EudraCT number |
2019-000898-23 |
Trial protocol |
GB |
Global end of trial date |
12 Feb 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Jan 2021
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First version publication date |
14 Jan 2021
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Other versions |
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Summary report(s) |
Trauma-INTACT publication Trauma-INTACT figures Trauma-INTACT supplementary table |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2019/KEP/218
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03875937 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
London School of Hygiene and Tropical Medicine
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Sponsor organisation address |
Keppel Street, London, United Kingdom, WC1E 7HT
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Public contact |
Clinical Trials Unit, London School of Hygiene and Tropical Medicine, 0207 2994684, traumaim@Lshtm.ac.uk
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Scientific contact |
Clinical Trials Unit, London School of Hygiene and Tropical Medicine, 0207 2994684, traumaim@Lshtm.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Sep 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Feb 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Feb 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Sep 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
1
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Adults (18-64 years) |
20
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From 65 to 84 years |
6
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85 years and over |
3
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Recruitment
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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
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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
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Tranexamic acid | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Tranexamic Acid
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Investigational medicinal product code |
B02AA02
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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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)
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tranexamic acid
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Reporting group description |
- |
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End point title |
Serum concentration over time [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
Within 4 minutes of administration of i.m. TXA
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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 |
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Attachments |
Trauma-INTACT figures |
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No statistical analyses for this end point |
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End point title |
Serum concentration over time [2] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
Within 11 minutes of i.m. TXA
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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 |
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Attachments |
Trauma-INTACT figures |
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No statistical analyses for this end point |
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End point title |
Local reactions at injection site | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up to 7 days
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to 7 days
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
Tranexamic acid
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |