Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial.

作者：F. Guyette, Joshua B. Brown, M. Zenati, Barbara J. Early-Young, Peter W. Adams, B. Eastridge, R. Nirula, G. Vercruysse, T. O'keeffe, B. Joseph, L. Alarcon, C. Callaway, B. Zuckerbraun, M. Neal, R. Forsythe, M. Rosengart, T. Billiar, D. Yealy, A. Peitzman, J. Sperry · 发表于：JAMA Surgery · 年份：2020 · DOI：10.1001/jamasurg.2020.4350 · 被引用次数：210 · 研究领域：Medicine

Importance In-hospital administration of tranexamic acid after injury improves outcomes in patients at risk for hemorrhage. Data demonstrating the benefit and safety of the pragmatic use of tranexamic acid in the prehospital phase of care are lacking for these patients. Objective To assess the effectiveness and safety of tranexamic acid administered before hospitalization compared with placebo in injured patients at risk for hemorrhage. Design, Setting, and Participants This pragmatic, phase 3, multicenter, double-blind, placebo-controlled, superiority randomized clinical trial included injured patients with prehospital hypotension (systolic blood pressure ≤90 mm Hg) or tachycardia (heart rate ≥110/min) before arrival at 1 of 4 US level 1 trauma centers, within an estimated 2 hours of injury, from May 1, 2015, through October 31, 2019. Interventions Patients received 1 g of tranexamic acid before hospitalization (447 patients) or placebo (456 patients) infused for 10 minutes in 100 mL of saline. The randomization scheme used prehospital and in-hospital phase assignments, and patients administered tranexamic acid were allocated to abbreviated, standard, and repeat bolus dosing regimens on trauma center arrival. Main Outcomes and Measures The primary outcome was 30-day all-cause mortality. Results In all, 927 patients (mean [SD] age, 42 [18] years; 686 [74.0%] male) were eligible for prehospital enrollment (460 randomized to tranexamic acid intervention; 467 to placeb...