The Trauma INtramuscular Tranexamic Acid Clinical Trial (TraumaINTACT)

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Traumatic Haemorrhage

Treatments: Drug: Tranexamic 1 gram

Study type: Interventional

Funder types: Other

Identifiers

NCT03875937

2019/KEP/218

2019-000898-23 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Tranexamic acid 1 gram intramuscularly

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic 1 gram