Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial
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. Howeve...
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2021-03-01
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| author | Stephen Bernard Ann-Marie Baker Peter Cameron Mark Fitzgerald Andrew Forbes Paul Young Colin McArthur Paul S Myles Russell Gruen Biswadev Mitra Russell L Gruen Dashiell Gantner Marc Maegele Lynnette Murray Tony Trapani Stephen Rashford Tony Smith Michael C Reade Veronica Pitt Robert Medcalf Michael Reade Huyen Tran Grant Christey Zsolt J Balogh Anthony Trapani Lynne Murray Stefan Mazur Camila Battistuzzo Andy Swain Jasmin Board Nicole S Ng Sally Hurford |
| author_facet | Stephen Bernard Ann-Marie Baker Peter Cameron Mark Fitzgerald Andrew Forbes Paul Young Colin McArthur Paul S Myles Russell Gruen Biswadev Mitra Russell L Gruen Dashiell Gantner Marc Maegele Lynnette Murray Tony Trapani Stephen Rashford Tony Smith Michael C Reade Veronica Pitt Robert Medcalf Michael Reade Huyen Tran Grant Christey Zsolt J Balogh Anthony Trapani Lynne Murray Stefan Mazur Camila Battistuzzo Andy Swain Jasmin Board Nicole S Ng Sally Hurford |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-f1beea52bfdd43599f1da549613e4e2a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-03-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-f1beea52bfdd43599f1da549613e4e2a2024-11-17T18:25:09ZengBMJ Publishing GroupBMJ Open2044-60552021-03-0111310.1136/bmjopen-2020-046522Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial 0Stephen Bernard1Ann-Marie Baker2Peter Cameron3Mark Fitzgerald4Andrew Forbes5Paul Young6Colin McArthur7Paul S Myles8Russell GruenBiswadev Mitra9Russell L Gruen10Dashiell Gantner11Marc Maegele12Lynnette Murray13Tony Trapani14Stephen Rashford15Tony Smith16Michael C Reade17Veronica Pitt18Robert MedcalfMichael Reade19Huyen TranGrant ChristeyZsolt J BaloghAnthony Trapani20Lynne Murray21Stefan MazurCamila BattistuzzoAndy Swain22Jasmin BoardNicole S NgSally Hurford3University College London6 Ambulance Victoria, Doncaster, Victoria, Australia1 Centre for Tumour Biology, Barts Cancer Institute, Queen Mary University of London, London, UKSchool of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, AustraliaTrauma Service, Alfred Health, Melbourne, VIC, AustraliaDepartment of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia15 Intensive Care Department, Wellington Hospital, London, UKdirector of intensive careAnaesthesia and Perioperative Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, AustraliaEmergency and Trauma Centre, Alfred Health, Melbourne, Victoria, AustraliaCollege of Health and Medicine, Australian National University, Canberra, Australian Capital Territory, AustraliaDepartment of Epidemiology and Preventive Medicine, Monash University School of Public Health and Preventive Medicine, Melbourne, Victoria, AustraliaCologne Merheim Medical Center, Department of Traumatology, Othopedic Surgery and Sportsmedicine, University of Witten/Herdecke, Cologne, GermanyDepartment of Epidemiology and Preventive Medicine, Monash University School of Public Health and Preventive Medicine, Melbourne, Victoria, AustraliaDepartment of Epidemiology and Preventive Medicine, Monash University School of Public Health and Preventive Medicine, Melbourne, Victoria, AustraliaQueensland Ambulance Service, Brisbane, Queensland, Australia8St John, Auckland, New ZealandThe University of Queensland - Saint Lucia Campus, Brisbane, Queensland, AustraliaDepartment of Epidemiology and Preventive Medicine, Monash University School of Public Health and Preventive Medicine, Melbourne, Victoria, AustraliaDepartment of Intensive Care Medicine, Royal Brisbane and Women`s Hospital, Brisbane, Queensland, AustraliaAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia1 Regeneration, Research and Early Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom10Wellington Free Ambulance, Wellington, New ZealandIntroduction 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.https://bmjopen.bmj.com/content/11/3/e046522.full |
| spellingShingle | Stephen Bernard Ann-Marie Baker Peter Cameron Mark Fitzgerald Andrew Forbes Paul Young Colin McArthur Paul S Myles Russell Gruen Biswadev Mitra Russell L Gruen Dashiell Gantner Marc Maegele Lynnette Murray Tony Trapani Stephen Rashford Tony Smith Michael C Reade Veronica Pitt Robert Medcalf Michael Reade Huyen Tran Grant Christey Zsolt J Balogh Anthony Trapani Lynne Murray Stefan Mazur Camila Battistuzzo Andy Swain Jasmin Board Nicole S Ng Sally Hurford Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial BMJ Open |
| title | Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial |
| title_full | Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial |
| title_fullStr | Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial |
| title_full_unstemmed | Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial |
| title_short | Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial |
| title_sort | protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma the patch trauma trial |
| url | https://bmjopen.bmj.com/content/11/3/e046522.full |
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