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Completed

NCT Number: NCT03875937

The Trauma INtramuscular Tranexamic Acid Clinical Trial

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

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Key information

Conditions

Traumatic Haemorrhage

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St George's Hospital, London, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic 1 gram

Drug

To be administered intramuscularly (2 injections)

Primary outcomes

  1. 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

  1. Number of participants with Injection sites reactions

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

  2. Number of adverse events reported by type

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

    adverse events will be coded using MedDRA

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Barts & The London NHS Trust
  • JP Moulton Charitable Foundation
  • St George's University Hospitals NHS Foundation Trust
  • University of Versailles

Registry information

Official study title

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

Acronym: TraumaINTACT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.