Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial

Biswadev Mitra; Stephen Bernard; Dashiell Gantner; Brian Burns; Michael C Reade; Lynnette Murray; Tony Trapani; Veronica Pitt; Colin McArthur; Andrew Forbes; Marc Maegele; Russell L Gruen; PATCH-Trauma study investigators; PATCH-Trauma Study investigators

doi:10.1136/bmjopen-2020-046522

Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial

BMJ Open. 2021 Mar 15;11(3):e046522. doi: 10.1136/bmjopen-2020-046522.

Authors

Biswadev Mitra^{1

2

3}, Stephen Bernard^{3

4

5}, Dashiell Gantner^{3

4

6}, Brian Burns^{7

8}, Michael C Reade^{9

10

11}, Lynnette Murray^{3

4

6}, Tony Trapani^{3

4

6}, Veronica Pitt³, Colin McArthur¹², Andrew Forbes³, Marc Maegele^{13

14}, Russell L Gruen¹⁵; PATCH-Trauma study investigators; PATCH-Trauma Study investigators

Affiliations

¹ Emergency and Trauma Centre, Alfred Hospital, Melbourne, Victoria, Australia biswadev.mitra@monash.edu.
² National Trauma Research Institute, Melbourne, Victoria, Australia.
³ Department of Epidemiology and Preventive Medicine, Monash University School of Public Health and Preventive Medicine, Melbourne, Victoria, Australia.
⁴ Department of Intensive Care, Alfred Hospital, Melbourne, Victoria, Australia.
⁵ Ambulance Victoria, Melbourne, Victoria, Australia.
⁶ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.
⁷ Greater Sydney Area Helicopter Emergency Medical Service, Sydney, New South Wales, Australia.
⁸ Sydney Medical School, Sydney University, Sydney, New South Wales, Australia.
⁹ Faculty of Medicine, The University of Queensland, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
¹⁰ Joint Health Command, Australian Defence Force, Canberra, Australian Capital Territory, Australia.
¹¹ Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
¹² Critical Care Medicine, Auckland District Health Board, Auckland, New Zealand.
¹³ Cologne Merheim Medical Center, Department of Traumatology, Othopedic Surgery and Sportsmedicine, University of Witten/Herdecke, Cologne, Germany.
¹⁴ Institute for Research in Operative Medicine, University Witten-Herdecke, Cologne, Germany.
¹⁵ College of Health and Medicine, Australian National University, Canberra, Australian Capital Territory, Australia.

Abstract

Introduction: Haemorrhage causes most preventable prehospital trauma deaths and about a third of in-hospital trauma deaths. Tranexamic acid (TXA), administered soon after hospital arrival in certain trauma systems, is an effective therapy in preventing or managing acute traumatic coagulopathy. However, delayed administration of TXA appears to be ineffective or harmful. The effectiveness of prehospital TXA, incidence of thrombotic complications, benefit versus risk in advanced trauma systems and the mechanism of benefit remain uncertain.

Methods and analysis: 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. We present the trial protocol and an overview of the statistical analysis plan. There will be 1316 patients recruited by prehospital clinicians in Australia, New Zealand and Germany. 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. 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.

Ethics and dissemination: 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. In New Zealand, Northern A Health and Disability Ethics Committee provided approval. In Germany, Witten/Herdecke University has provided ethics approval. The PATCH-Trauma study aims to provide definitive evidence of the effectiveness of prehospital TXA, when used in conjunction with current advanced trauma care, in improving outcomes after severe injury.

Trial registration number: NCT02187120.

Keywords: accident & emergency medicine; bleeding disorders & coagulopathies; blood bank & transfusion medicine; trauma management.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Antifibrinolytic Agents* / therapeutic use
Emergency Medical Services*
Germany
Humans
Multicenter Studies as Topic
New South Wales
New Zealand
Northern Territory
Quality of Life
Queensland
Randomized Controlled Trials as Topic
South Australia
Tasmania
Tranexamic Acid* / therapeutic use
Victoria

Substances

Antifibrinolytic Agents
Tranexamic Acid

Associated data

ClinicalTrials.gov/NCT02187120