Therapy
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
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Summary
Posted By: stuart green
E-Mail: stuart_green@health.qld.gov.au
Posted Date: 19/7/2010
Title: 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
Authors: CRASH-2 trial collaborators*
Reference: Preprint
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract: Summary 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 occlusive events, and the receipt of blood transfusion in trauma patients. Methods This 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.gov NCT00375258, and South African Clinical Trial Register DOH-27-0607-1919. Findings 10 096 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 [145%] tranexamic acid group vs 1613 [160%] placebo group; relative risk 091, 95% CI 085097; p=00035). The risk of death due to bleeding was significantly reduced (489 [49%] vs 574 [57%]; relative risk 085, 95% CI 076096; p=00077). 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.
 
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? (Was allocation concealment maintained?)
Yes Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. In hospitals in which telephone randomisation was not practicable we used a local pack system that selected the lowest numbered treatment pack from a box containing eight numbered packs. Apart from the pack number, the treatment packs were identical. The pack number was recorded on the entry form which was sent to the international trial coordinating centre in London, UK. Hospitals with reliable telephone access used the University of Oxford Clinical Trial Service Unit (CTSU) telephone randomisation service. The randomisation service used a minimisation algorithm balancing Protocol @http://www.crash2.lshtm.ac.uk/Protocol_Eng.html
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
Nearly all patients were fully followed up-remarkable for 20000+patients around the world. Lost 80 (<0.3%) Consent withdrawn 4 (<0.02%) Had full treatment 18965 (~94%)
2b. Were patients analyzed in the groups to which they were randomized?
Yes explicly stated "intention to treat analysis"
3. Were patients, health workers, and study personnel blind to treatment?
Yes
4. Were the groups similar at the start of the trial?
Yes
5. Aside from the experimental intervention, were the groups treated equally?
As blinding was complete, this is expected.
What are the Results?
1. How large was the treatment effect?
Tranexamic acid reduced death from 16% in placebo group to 14.5%(p=0.0035 RR-0.85 CI 0.85-0.97) Table 2 Tranexamic acid (n=10 060) Placebo (n=10 067) RR (95% CI) p value (two-sided) Any cause of death 1463 (145%) 1613 (160%) 091 (085097) 00035 Bleeding 489 (49%) 574 (57%) 085 (076096) 00077 Vascular occlusion* 33 (03%) 48 (05%) 069 (044107) 0096 Multiorgan failure 209 (21%) 233 (23%) 090 (075108) 025 Head injury 603 (60%) 621 (62%) 097 (087108) 060 Other causes 129 (13%) 137 (14%) 094 (074120) 063
2. How precise was the estimate of the treatment effect?
as above
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
short Yes. Mixed trauma, many countries.
2. Were all clinically important outcomes considered?
Yes. Major concern would thrombotic complications, these were assessed and were not significently diffrent.
3. Are the likely treatment benefits worth the potential harms and costs?
Cheap, easy-Yes

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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

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