The Trauma INtramuscular Tranexamic Acid Clinical Trial

Traumatic Haemorrhage Clinical Trial

— TraumaINTACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875937
• Other study ID #: 2019/KEP/218
• Secondary ID: 2019-000898-23
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 17, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: February 2020
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Traumatic Haemorrhage

Intervention

Drug:
• Tranexamic 1 gram
To be administered intramuscularly (2 injections)

Locations

Country	Name	City	State
United Kingdom	St George's Hospital	London
United Kingdom	The Royal London Hospital	London

Sponsors (5)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Barts & The London NHS Trust, JP Moulton Charitable Foundation, St George's University Hospitals NHS Foundation Trust, University of Versailles

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of serum TXA concentrations over time.		Blood samples will be taken pre-dose and up to 11 hours after IM TXA
Secondary	Number of participants with Injection sites reactions		death, discharge or day seven (whichever comes first)
Secondary	Number of adverse events reported by type	adverse events will be coded using MedDRA	death, discharge or day 7 (whichever comes first)