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.govNCT00375258, and South African Clinical Trial RegisterDOH-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 [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). 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. Copyright 2010 Elsevier Ltd. All rights reserved.
RCT Entities:
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 traumapatients. METHODS: This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult traumapatients 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. 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 [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). INTERPRETATION:Tranexamic acid safely reduced the risk of death in bleeding traumapatients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding traumapatients. FUNDING: UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation. Copyright 2010 Elsevier Ltd. All rights reserved.
Authors: Jason M Samuels; Ernest E Moore; Christopher C Silliman; Anirban Banerjee; Mitchell J Cohen; Arsen Ghasabyan; James Chandler; Julia R Coleman; Angela Sauaia Journal: J Trauma Acute Care Surg Date: 2019-04 Impact factor: 3.313
Authors: Anirban Banerjee; Christopher C Silliman; Ernest E Moore; Monika Dzieciatkowska; Marguerite Kelher; Angela Sauaia; Kenneth Jones; Michael P Chapman; Eduardo Gonzalez; Hunter B Moore; Angelo D'Alessandro; Erik Peltz; Benjamin E Huebner; Peter Einerson; James Chandler; Arsen Ghasabayan; Kirk Hansen Journal: J Trauma Acute Care Surg Date: 2018-06 Impact factor: 3.313
Authors: Donald H Jenkins; Joseph F Rappold; John F Badloe; Olle Berséus; Lorne Blackbourne; Karim H Brohi; Frank K Butler; Andrew P Cap; Mitchell Jay Cohen; Ross Davenport; Marc DePasquale; Heidi Doughty; Elon Glassberg; Tor Hervig; Timothy J Hooper; Rosemary Kozar; Marc Maegele; Ernest E Moore; Alan Murdock; Paul M Ness; Shibani Pati; Todd Rasmussen; Anne Sailliol; Martin A Schreiber; Geir Arne Sunde; Leo M G van de Watering; Kevin R Ward; Richard B Weiskopf; Nathan J White; Geir Strandenes; Philip C Spinella Journal: Shock Date: 2014-05 Impact factor: 3.454