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CRASH-2: Tranexamic acid decreased mortality in trauma patients at risk for bleeding

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Tranexamic acid was safe and effective and reduced the risk for all-cause mortality when administered within 1 month among trauma patients at risk for hemorrhage, according to new findings from the Clinical Randomization of an Antifibrinolytic in Significant Hemorrhage 2 trial.

“This simple, inexpensive treatment could save thousands of lives worldwide — a tremendous result — the result of an unprecedented global collaboration of doctors from high, middle and low income countries,” Ian Roberts, MD, professor of epidemiology, at the London School of Hygiene and Tropical Medicine, United Kingdom, told HemOnc Today.

Clinical Randomization of an Antifibrinolytic in Significant Hemorrhage 2 (CRASH-2) researchers assessed the effects of early administration of tranexamic acid (Cyklokapron) on mortality, vascular occlusive events and blood transfusions in 20,211 trauma patients at 274 hospitals in 40 countries.

Patients were randomly assigned within 8 hours of injury to either tranexamic acid injection 1 g for 10 minutes duration then 1 g for 8 hours duration (n=10,060) or matching placebo (n= 10,067).

Primary outcome measure was mortality within 4 weeks of injury during hospital stay — grouped as: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, or other. All analyses were intention to treat.

Tranexamic acid significantly reduced all-cause mortality in 14.5% of patients assigned tranexamic acid when compared with 16% of patients assigned placebo (RR=0.91; 95% CI, 0.85–0.97; P=.0035). Moreover, the risk for mortality caused by bleeding was significantly reduced in 4.9% of patients assigned tranexamic acid vs. 5.7% of those assigned placebo (RR=0.85; 95% CI, 0.76–0.96; P=.0077).

In addition, mortality caused by vascular occlusion occurred in only 0.3% of those assigned tranexamic acid vs. 0.5% of those assigned placebo. Of these, seven vs. 22 deaths occurred from MI, eight vs. five from stroke and 18 vs. 21 from pulmonary embolism, respectively.

Of those assigned tranexamic acid, 34.3% were classified as dead or dependent at discharge or at day 28 when compared with 35.4% of those assigned placebo (RR=0.97; 95% CI, 0.93-1.0; P=.12).

About 15% of those assigned tranexamic acid reported no symptoms at discharge or at day 28 vs. 13.3% of those assigned placebo.

In an accompanying editorial, Jerrold H. Levy, MD, of Emory University School of Medicine, wrote, “[This] study shows that inhibition of fibrinolysis 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.” – by Jennifer Southall

Roberts I. Lancet. 2010;doi:10.1016/S0140-6736(10)60835-5.

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