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Trauma-INTACT

Trauma-INTACT is a prospective, open-label, multicentre, pharmacokinetic study.

Objective: 

To assess the population pharmacokinetics of intramuscular TXA in trauma patients.

Background: 

The anti-fibrinolytic TXA has been licensed for over 30 years for use in the prevention and treatment of haemorrhage. More recently, large clinical trials have shown that TXA reduces death from bleeding after trauma and post-partum haemorrhage (PPH). Urgent treatment is essential. Most haemorrhage deaths occur soon after bleeding onset and treatment delay reduces the survival benefit. Every fifteen minutes treatment delay reduces the survival benefit by about 10% until around 3 hours after which there is no benefit. To reduce treatment delay, UK patients with serious injury are often given an intravenous (IV) injection of TXA in the ambulance, before they get to hospital. Nevertheless,there are times when giving an IV injection is difficult, such as in patients trapped in crashed vehicles or soldiers in combat situations with no medics available. If TXA could be given by intramuscular (IM) injection, rapid  administration would be possible even in difficult situations.

If absorption was similarly rapid in trauma patients, this would strongly suggest the IM route as a potential alternative to IV use. In this study we will assess the population pharmacokinetics of IM TXA in trauma patients.

STATUS

Trial set-up

START DATE

1 May 2019

END DATE

31 October 2020

FUNDERS
J P Moulton Charitable Foundation
EXISTING LOCATIONS