The Trauma INtramuscular Tranexamic Acid Clinical Trial

NCT03875937 | Completed Phase 1

• 2 other identifiers: 2019/KEP/2182019-000898-23
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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

Conditions

Traumatic Haemorrhage

Keywords

tranexamic acid; pharmacokinetic; intramuscular

Outcome Measures

Primary Outcomes (1)

• Concentration of serum TXA concentrations over time.

  Blood samples will be taken pre-dose and up to 11 hours after IM TXA

Secondary Outcomes (2)

• 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)

Study Arms (1)

Tranexamic acid 1 gram intramuscularly

EXPERIMENTAL

Patients will receive a 1 gram dose of TXA by IM injection at least 1 hour and 30 minutes after their initial IV injection received at the scene or on arrival to hospital. The IM dose will be given as two 5mL (0.5 gram each) injections into the thigh (rectus femoris or vastus lateralis), gluteal or deltoid muscles, depending on the clinical scenario (e.g. taking into account the type of injury). Injections should be given in a non-injured muscle.

Drug: Tranexamic 1 gram

Interventions

Tranexamic 1 gram DRUG

To be administered intramuscularly (2 injections)

Tranexamic acid 1 gram intramuscularly

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Barts & The London NHS Trust: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• University of Versailles: collaborator
• JP Moulton Charitable Foundation: collaborator

Study Sites (2)

The Royal London Hospital

London, E1 1FR, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• Grassin-Delyle S, Shakur-Still H, Picetti R, Frimley L, Jarman H, Davenport R, McGuinness W, Moss P, Pott J, Tai N, Lamy E, Urien S, Prowse D, Thayne A, Gilliam C, Pynn H, Roberts I. Pharmacokinetics of intramuscular tranexamic acid in bleeding trauma patients: a clinical trial. Br J Anaesth. 2021 Jan;126(1):201-209. doi: 10.1016/j.bja.2020.07.058. Epub 2020 Sep 30.

  PMID: 33010927 DERIVED

Study Officials

• Haleema Shakur-Still

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Ian Roberts

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, multicentre, pharmacokinetic study.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: September 17, 2019
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: freely available 1 year after main publication
• Access Criteria: Free login to website required for monitoring usage of data

Locations

GB (2)