Results from an international trial involving over 20,000 participants in 40 countries suggest that if recently injured patients with serious bleeding were to be given an injection of a cheap, widely available drug, it could save the lives of tens of thousands of people every year worldwide, including victims of traffic accidents, shootings, stabbings and land mine injuries.

The results of the CRASH-2 study, a large, randomised trial involving over 20,000 adult patients in 274 hospitals in 40 countries, are published in the 14 June online issue of The Lancet, along with other information and an editorial commentary.

The trial was funded by England’s National Institute for Health Research (NIHR) Health Technology Assessment programme and was led by Dr Ian Roberts, Professor of Epidemiology at the London School of Hygiene and Tropical Medicine (LSHTM).

Roberts and colleagues found that early administration of tranexamic acid (TXA, a drug that reduces clot breakdown) to patients with severe, recent bleeding injuries saves lives with no evidence of side effects from unwanted clotting.

They suggest using the the widely available and easily administered off-patent drug, which is manufactured by a number of different companies, and costs about £3 ($4.50) per gram, in this way could save tens of thousands of lives every year worldwide.

The trial was the first to test TXA in injured patients, although previous, smaller studies have shown that the drug also reduces bleeding in patients undergoing major surgery.

The trial was necessary to check the safety of TXA for this type of use, because although it is obviously an advantage to have a drug that reduces clot breakdown in situations of severe bleeding, doctors were concerned about side effects like increased risk of complications like heart attacks, strokes and blood clots in the lungs.

However, the trial showed TXA reduced deaths from bleeding with no increase in such complications.

Roberts told the press that about 600,000 injured people bleed to death every year around the world: it is the second biggest killer of people between 5 and 45 years old, second only to HIV/AIDS.

“Injuries may be accidental, for example traffic crashes, or intentional, such as shootings, stabbings or land mine injuries and the majority of deaths occur soon after injury,” explained Roberts, adding that:

“Although most deaths from injuries are in developing countries, injury is a leading cause of death in young adults throughout the world.”

He said it was also important to note that deaths from injuries are on the rise the globe over, and often the victims are young adults with families to support.

For the study, Roberts and colleagues only enrolled patients who had significant bleeding, or were at risk of significant bleeding and the injury had happened within the last few hours.

They randomly allocated participants to either the treatment group or the placebo group. The treatment group received one gram of TXA by injection followed by another 1 gram in a drip in the following 8 hours. The placebo group had the same treatment but received a matching placebo instead of the TXA.

They followed up the patients in both groups for 4 weeks after injury, counting all deaths. The analysis showed that compared to placebo, TXA reduced the chance of death due to massive blood loss by around one sixth.

Roberts and colleagues estimated that TXA used in this way could save up to 100,000 lives worldwide, including 13,000 in India and 12,000 in China.

Roberts said:

“We believe that doctors across the world should now consider using it [TXA] to improve accident victims’ chances of survival and that it should be considered for inclusion in the WHO List of Essential Medicines.”

Article and other information on crash-2 from The Lancet.

Source: LSHTM.

Written by: Catharine Paddock, PhD