The Trauma INtramuscular Tranexamic Acid Clinical Trial

Phase 1

Completed

• Conditions: Traumatic Haemorrhage
• Interventions: Drug: Tranexamic 1 gram

• Registration Number: NCT03875937
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Study Start: 2019-09-17
• Status Verified: 2020-02
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranexamic acid 1 gram intramuscularly	Tranexamic 1 gram	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of participants with Injection sites reactions	death, discharge or day seven (whichever comes first)
Number of adverse events reported by type	death, discharge or day 7 (whichever comes first)	adverse events will be coded using MedDRA

Trial Locations

Locations (2)

St George's Hospital; 🇬🇧 London, United Kingdom

The Royal London Hospital; 🇬🇧 London, United Kingdom