The CRASH-2 trial: Tranexamic acid in trauma patients [Classics Series]

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1. Tranexamic acid significantly reduces all-cause mortality in trauma patients with significant hemorrhage.

2. There were no significant differences between the tranexamic acid and placebo groups with regards to the incidence of vascular occlusive events or the need for transfusion or surgery.

Original Date of Publication: July 3, 2010

Study Rundown: While prior studies have demonstrated benefit in using tranexamic acid to manage surgical bleeding, no randomized trials had explored its use in managing trauma patients. The CRASH-II trial demonstrates that using tranexamic acid in trauma patients suffering from significant hemorrhage reduces all-cause mortality without any significant increase in the incidence of fatal or non-fatal vascular occlusive events. Subsequent analyses of the CRASH-II trial data have demonstrated that tranexamic acid should be delivered as soon as possible, as it is much less effective when given more than three hours following the injury. Given its effectiveness and cost-effectiveness, authors of the CRASH-II trial called for tranexamic acid to be added to the World Health Organization’s List of Essential Medicines, and it was included in March 2011.

Please click to read study in The Lancet

In-Depth [randomized, controlled trial]: The CRASH-II trial, originally published in The Lancet in 2010, was conducted to explore the effects of tranexamic acid in managing trauma patients with significant hemorrhage. A total of 20,211 patients were drawn from 274 hospitals in 40 countries and randomized as part of the study. Patients were considered eligible if they suffered significant hemorrhage (i.e., systolic blood pressure <90 mmHg, or heart rate >110 beats per minute, or both) or were at risk of significant hemorrhage, and were being treated within 8 hours of injury. Only patients where the responsible physician was uncertain about whether to treat with tranexamic acid were eligible; patients with clear indications or contraindications were excluded. Patients randomized to the tranexamic acid group received a loading dose of 1 g infused intravenously over 10 minutes, followed by 1 g over 8 hours.

The primary outcome was death in hospital within 4 weeks of injury, while secondary outcomes included vascular occlusive events, surgical intervention, receipt of blood transfusion, and the number of units of blood products transfused. Tranexamic acid was found to significantly reduce all-cause mortality (RR 0.91; 95% CI 0.85-0.97). In particular, patients in the tranexamic group were at significantly lower risk of death secondary to bleeding (RR 0.85; 95% CI 0.76-0.96). There were no significant differences between the two groups in the risk of fatal or non-fatal vascular occlusive events or need for transfusion of blood products or surgery.

By Aimee Li, M.D.; Andrew Cheung, M.D.

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