June 14, 2010 -- The lives of between 70,000 and 100,000 trauma victims worldwide could be saved each year if they were given access to a cheap, widely available, and easily administered medication, a study shows.
Experts involved in the CRASH-2 study say that tranexamic acid (TXA), which reduces the rate of blood-clot breakdown, is so effective it should be included on the World Health Organization (WHO) list of essential medicines.
Injuries are a leading cause of death worldwide. Etienne Krug, MD, director of violence and injury prevention and disability at the World Health Organization, said at a news conference that "5.8 million die every year from injuries. This is much more than HIV, TB, and malaria deaths combined."
Of those deaths, more than 2 million die as a result of road traffic injuries, making it the ninth leading cause of death globally. About 1.6 million die from violence, warfare, and suicide. Furthermore, hemorrhage is responsible for about a third of in-hospital trauma deaths, as well as contributing to deaths from multi-organ failure.
"Each year about 600,000 injured patients bleed to death worldwide," said chief investigator Ian Roberts, professor at the London School of Hygiene and Tropical Medicine, in a statement.
Researchers carried out a trial involving more than 20,000 adult patients in 274 hospitals across 40 countries. Participants were randomly assigned to receive either 1 gram of TXA by injection followed by another 1 gram in a drip over the following eight hours, or a matching placebo.
The researchers studied the numbers of deaths in hospitals within four weeks of injury. They discovered that TXA reduced the risk of death by any cause by 10% compared with those who received the placebo; 14.5% of patients in the TXA group died compared with 16% in the placebo group.
Although the research team was concerned that TXA might increase the risk of complications, such as heart attacks, strokes, and clots in the lungs, they said that the results of CRASH-2 showed that TXA reduces death from bleeding without any increase in these complications. "The good news was we didn't see any evidence of increase [in unwanted clotting] at all," Roberts told the press conference. "In fact, we saw some decrease in the risk."
Saving up to 100,000 Lives
The researchers estimate that TXA could prevent between 70,000 and 100,000 deaths worldwide if it were readily available for trauma victims. In India it could save about 13,000 lives each year, and in China, 12,000. The medication could also have a dramatic impact on deaths in developed countries, with about 2,000 lives saved each year in the U.S. and more across Europe.
"Patients with severe injuries die very soon after their injuries," Roberts told the press conference, held at the London School of Hygiene and Tropical Medicine. Sixty percent of people who die after injury do so on the first day, Roberts said. "People bleed to death in the emergency department, so this is an emergency treatment."
The researchers conclude: "Tranexamic acid could be given in a wide range of health-care settings, and safely reduced the risk of death in bleeding trauma patients in our study. The option to use tranexamic acid should be available to doctors treating trauma patients in all countries, and this drug should be considered for inclusion on the WHO List of Essential Medicines."
The research is published in the Online First edition of The Lancet. It was funded by England's National Institute for Health Research (NIHR) Health Technology Assessment programme.
In an accompanying editorial, Jerrold H. Levy, MD, of Emory University School of Medicine in Atlanta, writes: "Today's study shows that inhibition of fibrinolysis [the process in which a blood clot is broken down] with tranexamic acid after major trauma is an important mechanism to reduce mortality. ... However, caution is needed before extrapolation of the results of CRASH-2 to other antifibrinolytic agents until they have been studied in a similarly robust manner."