The Trauma INtramuscular Tranexamic Acid Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2020-02-12

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

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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.

Conditions

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Traumatic Haemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, open-label, multicentre, pharmacokinetic study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tranexamic acid 1 gram intramuscularly

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.

Group Type EXPERIMENTAL

Tranexamic 1 gram

Intervention Type DRUG

To be administered intramuscularly (2 injections)

Interventions

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Tranexamic 1 gram

To be administered intramuscularly (2 injections)

Intervention Type DRUG

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.