The Trauma INtramuscular Tranexamic Acid Clinical Trial

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03875937

Acronym

TraumaINTACT

Enrollment

Registered

2019-03-15

Start date

2019-09-17

Completion date

2020-02-12

Last updated

2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Haemorrhage

Keywords

tranexamic acid, pharmacokinetic, intramuscular

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.

Interventions

DRUGTranexamic 1 gram

To be administered intramuscularly (2 injections)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Prospective, open-label, multicentre, pharmacokinetic study.

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026