• CRASH-2 trial collaborators, Haleema Shakur, Ian Roberts, Raúl Bautista, José Caballero, Tim Coats, Yashbir Dewan, Hesham El-Sayed, Tamar Gogichaishvili, Sanjay Gupta, Jorge Herrera, Beverley Hunt, Pius Iribhogbe, Mario Izurieta, Hussein Khamis, Edward Komolafe, María-Acelia Marrero, Jorge Mejía-Mantilla, Jaime Miranda, Carlos Morales, Oluwole Olaomi, Fatos Olldashi, Pablo Perel, Richard Peto, P V Ramana, R R Ravi, and Surakrant Yutthakasemsunt.
• Clinical Trials Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
• Lancet. 2010 Jul 3; 376 (9734): 233223-32.

BackgroundTranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients.MethodsThis randomised controlled trial was 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 tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.govNCT00375258, and South African Clinical Trial RegisterDOH-27-0607-1919.Findings10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (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).InterpretationTranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients.FundingUK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.Copyright 2010 Elsevier Ltd. All rights reserved.

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