• PATCH-Trauma Investigators and the ANZICS Clinical Trials Group, Russell L Gruen, Biswadev Mitra, Stephen A Bernard, Colin J McArthur, Brian Burns, Dashiell C Gantner, Marc Maegele, Peter A Cameron, Bridget Dicker, Andrew B Forbes, Sally Hurford, Catherine A Martin, Stefan M Mazur, Robert L Medcalf, Lynnette J Murray, Paul S Myles, Sze J Ng, Veronica Pitt, Stephen Rashford, Michael C Reade, Andrew H Swain, Tony Trapani, and Paul J Young.
• From the College of Health and Medicine, Australian National University (R.L.G.), Canberra Health Services (R.L.G.), and Joint Health Command, Australian Defence Force (M.C.R.), Canberra, ACT, the Emergency and Trauma Centre (B.M., P.A.C.) and the Departments of Anaesthesiology and Perioperative Medicine (P.S.M.) and Intensive Care (S.A.B., D.C.G.), Alfred Hospital, the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (D.C.G., L.J.M., S.J.N., T.T., P.J.Y.), the School of Public Health and Preventive Medicine (B.M., S.A.B., C.J.M., P.A.C., A.B.F., C.A.M., V.P.), the Australian Centre for Blood Diseases (R.L.M.), and the Central Clinical School (P.S.M.), Monash University, Ambulance Victoria (S.A.B.), and the Department of Critical Care, University of Melbourne (P.J.Y.), Melbourne, Aeromedical Operations, NSW Ambulance, Trauma Service, Royal North Shore Hospital, and Sydney Medical School, University of Sydney, Sydney (B.B.), MedSTAR Emergency Medical Retrieval Services, South Australian Ambulance Service (S.M.M.), and the Emergency Department, Royal Adelaide Hospital (S.M.M.), Adelaide, SA, and Queensland Ambulance Service (S.R.) and the Faculty of Medicine, University of Queensland (M.C.R.), Brisbane - all in Australia; Te Toka Tumai Auckland City Hospital (C.J.M.), Hato Hone St. John, Mt. Wellington (B.D.), and the Department of Paramedicine, Faculty of Health and Environmental Sciences, Auckland University of Technology (B.D., A.H.S.), Auckland, and Medical Research Institute of New Zealand (C.J.M., S.H., P.J.Y.), Wellington Free Ambulance (A.H.S.), and the Intensive Care Unit, Wellington Hospital (P.J.Y.), Wellington - all in New Zealand; Cologne-Merheim Medical Center, Department of Traumatology, Orthopedic Surgery, and Sports Medicine, and the Institute for Research in Operative Medicine, Witten-Herdecke University - both in Cologne, Germany (M.M.).
• N. Engl. J. Med. 2023 Jul 13; 389 (2): 127136127-136.

BackgroundWhether prehospital administration of tranexamic acid increases the likelihood of survival with a favorable functional outcome among patients with major trauma and suspected trauma-induced coagulopathy who are being treated in advanced trauma systems is uncertain.MethodsWe randomly assigned adults with major trauma who were at risk for trauma-induced coagulopathy to receive tranexamic acid (administered intravenously as a bolus dose of 1 g before hospital admission, followed by a 1-g infusion over a period of 8 hours after arrival at the hospital) or matched placebo. The primary outcome was survival with a favorable functional outcome at 6 months after injury, as assessed with the use of the Glasgow Outcome Scale-Extended (GOS-E). Levels on the GOS-E range from 1 (death) to 8 ("upper good recovery" [no injury-related problems]). We defined survival with a favorable functional outcome as a GOS-E level of 5 ("lower moderate disability") or higher. Secondary outcomes included death from any cause within 28 days and within 6 months after injury.ResultsA total of 1310 patients were recruited by 15 emergency medical services in Australia, New Zealand, and Germany. Of these patients, 661 were assigned to receive tranexamic acid, and 646 were assigned to receive placebo; the trial-group assignment was unknown for 3 patients. Survival with a favorable functional outcome at 6 months occurred in 307 of 572 patients (53.7%) in the tranexamic acid group and in 299 of 559 (53.5%) in the placebo group (risk ratio, 1.00; 95% confidence interval [CI], 0.90 to 1.12; P = 0.95). At 28 days after injury, 113 of 653 patients (17.3%) in the tranexamic acid group and 139 of 637 (21.8%) in the placebo group had died (risk ratio, 0.79; 95% CI, 0.63 to 0.99). By 6 months, 123 of 648 patients (19.0%) in the tranexamic acid group and 144 of 629 (22.9%) in the placebo group had died (risk ratio, 0.83; 95% CI, 0.67 to 1.03). The number of serious adverse events, including vascular occlusive events, did not differ meaningfully between the groups.ConclusionsAmong adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo. (Funded by the Australian National Health and Medical Research Council and others; PATCH-Trauma ClinicalTrials.gov number, NCT02187120.).Copyright © 2023 Massachusetts Medical Society.

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