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
The article is reprinted after 'Lancet 2010; 376: 23-32' by the above collaborators with written permission from Lancet Authority.
Background: Tranexamic 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 ocdusive events, and the receipt of blood transfusion in trauma patients.
Methods: This randomised controlled trial was undertaken in 274 hospitals in 40 countries. In Bangladesh we have taken 12 patients for this study. 20211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of in jury to either tranexamic acid (loading dose 1 g over 10 mm 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 staft) 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 ocdusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN867SO1O2, Clinicaltrials.gov NCT00375258, and South African Clinical Trial Register DOH-27-0607.1919.
Findings: 10096 patients were allocated to tranexamic acid and 10115 to placebo, of whom 10060 and 10067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic add (1463(14.5%] tranexamic add group vs 1613 [16.0%] placebo group; relative risk 0.91, 95% Cl 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=O .0077).
Interpretation: Tranexamic 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.
Funding: UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.
Bangladesh Crit Care J September 2013; 1 (2): 71-79
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