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The Trauma INtramuscular Tranexamic Acid Clinical Trial

NCT03875937 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-04-10

No results posted yet for this study

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

Conditions

  • Traumatic Haemorrhage

Interventions

DRUG

Tranexamic 1 gram

To be administered intramuscularly (2 injections)

Sponsors & Collaborators

  • Barts & The London NHS Trust

    collaborator OTHER

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • University of Versailles

    collaborator OTHER

  • JP Moulton Charitable Foundation

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Haleema Shakur-Still · London School of Hygiene and Tropical Medicine

  • Ian Roberts · London School of Hygiene and Tropical Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03875937 on ClinicalTrials.gov