Clinical Trials Directory

Trials / Completed

CompletedNCT03875937

The Trauma INtramuscular Tranexamic Acid Clinical Trial

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
31 (actual)
Sponsor
London School of Hygiene and Tropical Medicine · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTranexamic 1 gramTo be administered intramuscularly (2 injections)

Timeline

Start date
2019-09-17
Primary completion
2020-02-12
Completion
2020-02-12
First posted
2019-03-15
Last updated
2020-04-10

Locations

2 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03875937. Inclusion in this directory is not an endorsement.