The Trauma INtramuscular Tranexamic Acid Clinical Trial

London School of Hygiene and Tropical Medicine31 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Traumatic Haemorrhage

Interventions

Tranexamic 1 gramDRUG

To be administered intramuscularly (2 injections)

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (2)

The Royal London Hospital

London, United Kingdom

St George's Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Concentration of serum TXA concentrations over time.

Time frame: Blood samples will be taken pre-dose and up to 11 hours after IM TXA

Secondary Outcomes

Number of participants with Injection sites reactions

Time frame: death, discharge or day seven (whichever comes first)

Number of adverse events reported by type

adverse events will be coded using MedDRA

Time frame: death, discharge or day 7 (whichever comes first)

Data from ClinicalTrials.gov

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