Traumatic bleeding, mostly from road traffic accidents or violent crime, kills around two million people worldwide each year, with more than 90% of these deaths occurring in low and middle income countries.
The School’s researchers identified tranexamic acid (TXA), a clot stabilising drug already in use for certain conditions, as having the potential to reduce bleeding in trauma patients, around a third of whom die from acute haemorrhage.
To investigate this question, a global collaboration of health professionals from high, middle and low income countries was established, coordinated by the Clinical Trials Unit at the School, to conduct the CRASH-2 trial: a randomised controlled trial on the effects of the early administration of TXA on death, vascular obstruction and blood transfusion.
Around 20,000 adults with significant traumatic bleeding were recruited from 274 hospitals in 40 countries. The patients were injected with TXA or placebo within a few hours of being injured, followed by another dose of either TXA or placebo in a drip over the next eight hours. TXA reduced the chances of death from severe blood loss by a third with no side effects.
The results were published in 2010 and the World Health Organization (WHO) included TXA on its essential medicines list in 2011.
Subsequent analyses of the CRASH-2 results showed strong evidence that early treatment with TXA was more effective in controlling traumatic bleeding than later treatment and that it could be administered to a wide range of patients. The initial trial results gained worldwide media coverage, helped by a coordinated media campaign by all the centres involved in the trial.
The CRASH-2 trial has changed the practices of the UK Ministry of Defence and the US Department of Defense. After reports that soldiers in Afghanistan and Iraq were being treated with an untested experimental blood-clotting drug, the trials team alerted MoD officials to the potential of TXA, and within weeks of the results being published in 2010, the British army incorporated the drug into its combat care treatment protocols – the first routine use of TXA.
TXA was the first drug to be fast-tracked for use in the NHS under the government’s medicines innovation scheme and is now used widely across the NHS.
The ongoing WOMAN trial, coordinated by the School with 13 partners, is investigating whether TXA can help save the lives of the 100,000 women who die every year because of blood loss in childbirth. And CRASH-3 is to investigate TXA for treatment of significant traumatic brain injury.