A major new trial will test a cheap, widely available drug that investigators hope could prevent tens of thousands of deaths from haemorrhage each year.
The trial, the clinical randomisation of an antifibrinolytic in significant haemorrhage (CRASH-2) trial, will test the effects of tranexamic acid (TXA), an antifibrinolytic, on mortality and need for transfusion among adult trauma patients with ongoing major haemorrhage or who have a significant risk of haemorrhage.
Among people aged between 5 years and 45 years worldwide trauma is second only to HIV and AIDS as a cause of death. Many of the three million patients who die each year from traumatic injury do so after reaching hospital.
Ian Roberts, a professor of epidemiology at the London School of Hygiene and Tropical Medicine and the lead researcher in the trial, said that traumatic injury has typically been a “poor relation” of chronic disease in terms of research effort. The first CRASH trial (the corticosteroid randomisation after significant head injury trial), showed that the widespread use of steroids for head injury, practised for decades, brought no significant benefit and may have done more harm than good.
Tranexamic acid is a good candidate to control traumatic haemorrhage because it is already widely used to control bleeding in surgery, said Professor Roberts. “If we can establish that TXA brings even a 2% benefit in survival, in half a million patients a year that would save 10 000 lives.”
The randomised, placebo controlled study is currently recruiting participants, and so far it has signed up 55 hospitals in 15 countries and about 1500 patients. The organisers hope to recruit a total of 20 000 subjects with a range of traumatic injuries.
One doctor involved in the trial who is all too well placed to study such injuries is Bassim Irheim Mohammad Al Sheibani, from Diwaniyah University Hospital in Diwaniyah province, Iraq. He has so far recruited eight patients, three quarters of whom have suffered injuries from the present civil unrest. The remaining two are car crash victims.
Dr Bassim says his hospital’s emergency department sees about 10 000 patients in a bad month, yet the hospital has no specialised emergency doctor, a common situation in Iraqi hospitals. “Many Iraqi physicians get away from this specialty because, first, there is no training centre, and, second, because the immediate violence commonly targets doctors working in the ER [emergency room].”
He added, “There is a special challenge in dealing with the relatives of the patient because any complication or death of the trauma patient can lead to violence against me or my team.” Dr Bassim also has to drive 220 km along a dangerous road to Baghdad to pick up the trial materials.
The US and British armies have both expressed an interest in the trial, although they have yet to provide funding. Drug companies have not shown any interest, said Professor Roberts, “since the treatment has passed patent and is quite simple and cheap.”
See the trial’s website, www.crash2.lshtm.ac.uk.
