The Trauma INtramuscular Tranexamic Acid Clinical Trial

Study Overview
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Brief Summary
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Intramuscular injection of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics of intramuscular TXA in trauma patients. Primary endpoint: Serum TXA concentrations over time. Secondary endpoints: Local reactions at injection sites and adverse events

Detailed Description
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A prospective, open-label, multicentre, pharmacokinetic study conducted in the UK hospital. Potential eligible patients will have received a 1 gram IV dose of TXA at the scene of the injury or on arrival in hospital and a second dose is clinically indicated.

Official Title
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Pharmacokinetics of Intramuscular Tranexamic Acid in Trauma Patients: a Clinical Trial

Conditions
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Traumatic Haemorrhage

Intervention / Treatment
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* Drug: Tranexamic 1 gram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (appear to be at least 16 years old) trauma patients who have received 1 gram of intravenous TXA for the management of haemorrhage in whom a second dose is clinically indicated are eligible. Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, open-label, multicentre, pharmacokinetic study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid 1 gram intramuscularly<br>Patients will receive a 1 gram dose of TXA by IM injection at least 1 hour and 30 minutes after their initial IV injection received at the scene or on arrival to hospital. The IM dose will be given as two 5mL (0.5 gram each) injections into the thigh (rectus femoris or vastus lateralis), gluteal or deltoid muscles, depending on the clinical scenario (e.g. taking into account the type of injury). Injections should be given in a non-injured muscle. | Drug: Tranexamic 1 gram<br>* To be administered intramuscularly (2 injections)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of serum TXA concentrations over time. |  | Blood samples will be taken pre-dose and up to 11 hours after IM TXA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Injection sites reactions |  | death, discharge or day seven (whichever comes first) | 
| Number of adverse events reported by type | adverse events will be coded using MedDRA | death, discharge or day 7 (whichever comes first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, pharmacokinetic, intramuscular