In Germany, Witten/Herdecke University has provided ethics approval. In New Zealand, Northern A Health and Disability Ethics Committee provided approval. The study was approved by The Alfred Hospital Research and Ethics Committee in Victoria and also approved in New South Wales, Queensland, South Australia, Tasmania and the Northern Territory. Secondary outcomes will include mortality at hospital discharge and at 6 months, blood product usage, quality of life and the incidence of predefined adverse events. The primary outcome will be the eight-level Glasgow Outcome Scale Extended (GOSE) at 6 months after injury, dichotomised to favourable (GOSE 5-8) and unfavourable (GOSE 1-4) outcomes, analysed using an intention-to-treat (ITT) approach. There will be 1316 patients recruited by prehospital clinicians in Australia, New Zealand and Germany. We present the trial protocol and an overview of the statistical analysis plan. The Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH-Trauma study) is comparing TXA, initiated prehospital and continued in hospital over 8 hours, with placebo in patients with severe trauma at risk of acute traumatic coagulopathy. The effectiveness of prehospital TXA, incidence of thrombotic complications, benefit versus risk in advanced trauma systems and the mechanism of benefit remain uncertain. However, delayed administration of TXA appears to be ineffective or harmful. Tranexamic acid (TXA), administered soon after hospital arrival in certain trauma systems, is an effective therapy in preventing or managing acute traumatic coagulopathy. Haemorrhage causes most preventable prehospital trauma deaths and about a third of in-hospital trauma deaths. 15 College of Health and Medicine, Australian National University, Canberra, Australian Capital Territory, Australia.14 Institute for Research in Operative Medicine, University Witten-Herdecke, Cologne, Germany.13 Cologne Merheim Medical Center, Department of Traumatology, Othopedic Surgery and Sportsmedicine, University of Witten/Herdecke, Cologne, Germany.12 Critical Care Medicine, Auckland District Health Board, Auckland, New Zealand.11 Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
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