Published in the Lancet in 2010, this aimed to assess the effects and cost-effectiveness of the early administration of a short course of TXA on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients.
This was a large randomised, placebo-controlled trial undertaken in 274 hospitals in 40 countries. 20,211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either TXA (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo.
10,096 patients were allocated to TXA and 10,115 to placebo, of whom 10,060 and 10,067, respectively, were analysed.
All-cause mortality was significantly reduced with TXA (1463 [14.5%] tranexamic acid group vs. 1613 [16.0%] placebo group; relative risk 0.91, 95% CI 0.85-0.97; p=0.0035).
The risk of death due to bleeding was significantly reduced (489 [4.9%] vs. 574 [5.7%]; relative risk 0.85, 95% CI 0.76-0.96; p=0.0077).
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