The TRAUMA INtramuscular Tranexamic Acid Clinical Trial-Trauma-INTACT
Research type
Research Study
Full title
Pharmacokinetics of intramuscular tranexamic acid in trauma patients: a clinical trial
IRAS ID
262119
Contact name
Ian Roberts
Contact email
Sponsor organisation
London School of Hygiene and Tropical Medicine
Eudract number
2019-000898-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 7 days
Research summary
Tranexamic acid (TXA) helps blood to clot to stop bleeding. Research have shown that TXA reduces death from severe bleeding after trauma and childbirth. However, treatment must be given as soon as possible after bleeding starts. To reduce delay, UK patients with serious injuries often receive TXA in the ambulance as an injection into a vein (IV). However, sometimes it is difficult to give IV-TXA early enough such as when patients are trapped in crashed vehicles. Giving TXA as an injection into the muscle (IM) would ensure patients receive the drug earlier. Studies in healthy volunteers show that effective levels of IM-TXA in the blood are reached within 30 minutes. If absorption of IM-TXA was similarly rapid in trauma patients, then IM-TXA could be used as an alternative when IV use is difficult. The Trauma-INTACT study will assess how fast IM-TXA is absorbed in adult trauma patients enrolled in two UK hospitals. All patients will receive the routine 1-gram IV-TXA. Normally, a second dose of IV-TXA may be given to further help with the management of bleeding. In the Trauma-INTACT study all patients will receive their second TXA dose into their muscle rather than into a vein. Because the second dose is often interrupted while the patient undergoes diagnostic tests (e.g. CT scanning) or surgery and is sometimes omitted completely, giving the second dose by intramuscular injection should not involve any risk. Intramuscular injection may cause some pain and redness at the injection site. However, these symptoms are unlikely to be significant in trauma patients who routinely receive strong analgesia. Eight blood samples (about 4 teaspoons) will be taken to carry out the analysis. Patients will be observed for a period of up to 7 days after the intramuscular injections to check for any reactions or adverse events.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/0945
Date of REC Opinion
1 Aug 2019
REC opinion
Further Information Favourable Opinion