Evidence: safety

Evidence: safety

In the CRASH-2 study, tranexamic acid reduced the risk of death in trauma patients with bleeding with no statistically significant increase in the risk of vascular occlusive events (including myocardial infarction, stroke and pulmonary embolism)[15].

No adverse events in the CRASH-2 trial were regarded by clinicians as serious, unexpected and suspected to be related to the study treatment[15].

An exploratory analysis of CRASH-2 data suggested that administration of tranexamic acid more than 3 hours after injury was not significantly effective in reducing the risk of all-cause death (RR 1.00, 95% CI 0.90–1.13) and increased the risk of death due to bleeding (RR 1.44, 95% CI 1.12–1.84)[16].

[15] CRASH-2 trial collaborators. (2010) 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 376: 23–32.

[16] CRASH-2 trial collaborators. (2011) The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet 377: 1096–101.