CRASH-2
CRASH-2 Trial Summary
Objective
The CRASH-2 (Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage 2) trial aimed to assess the effects of early administration of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage.
Methods
- Design: Multicenter, randomized, placebo-controlled trial.
- Participants: 20,211 adult trauma patients with, or at risk of, significant bleeding were enrolled from 274 hospitals in 40 countries within 8 hours of injury.
- Interventions: Patients were randomly assigned to receive either tranexamic acid (loading dose of 1 g over 10 minutes, followed by an infusion of 1 g over 8 hours) or matching placebo.
- Outcome Measures: The primary outcome was death in hospital within 4 weeks of injury. Secondary outcomes included vascular occlusive events, receipt of blood transfusion, and level of dependency at hospital discharge or on day 28 if still in hospital.
Results
- Primary Outcome: All-cause mortality was significantly reduced with tranexamic acid (14.5% vs. 16.0%; relative risk [RR] 0.91, 95% confidence interval [CI] 0.85–0.97; p=0.0035). Deaths due to bleeding were significantly reduced (4.9% vs. 5.7%; RR 0.85, 95% CI 0.76–0.96; p=0.0077).
- Secondary Outcomes: Vascular occlusive events did not differ significantly between the groups. The need for blood transfusion was slightly lower in the tranexamic acid group, but this was not statistically significant. Dependency at discharge or day 28 was slightly lower in the tranexamic acid group, but this was also not statistically significant.
Conclusion
The CRASH-2 trial demonstrated that early administration of tranexamic acid in trauma patients with significant haemorrhage reduced the risk of death due to bleeding and all-cause mortality without increasing the risk of vascular occlusive events. Tranexamic acid should be considered for use in bleeding trauma patients.
Reference
Roberts I, Shakur H, Afolabi A, et al. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010;376:23-32. doi:10.1016/S0140-6736(10)60835-5. File:CRASH2.pdf