The PATCH-Trauma Study Shines A New Light On Tranexamic Acid’s Role In Pre-hospital Treatment Of Major Trauma

A ground-breaking study, published in the New England Journal of Medicine, conducted by researchers from Aotearoa New Zealand, Australia, and Germany, has raised a challenging question — In the event of severe injury, would individuals want to receive a treatment which reduced their probability of dying but also increased their risk of surviving severely disabled? 
 

The Pre-hospital Antifibrinolytics for Traumatic Coagulopathy and Haemorrhage (PATCH-Trauma) Study focused on the use of tranexamic acid (TXA), a readily available drug known for its ability to limit bleeding during surgery. The research examined TXA's effectiveness as a pre-emptive measure for patients at risk of life-threatening bleeding following trauma, an area of ongoing controversy.

The PATCH-Trauma Study, coordinated in New Zealand by the Medical Research Institute of New Zealand (MRINZ), is a large trial in which treatment was administered at the scene of an accident or injury, or in an ambulance. Over the course of eight years, 1310 severely injured patients received treatment from 15 ambulance services and 21 trauma centres across New Zealand, Australia, and Germany.

In the study, patients were randomly assigned to receive pre-hospital TXA or a placebo, in addition to all usual care. The findings revealed that, on average, for every 100 patients who received TXA, there were four additional survivors at a six-month mark, but also four additional patients with severe disability requiring them to rely heavily on caregivers.

Injury is the leading cause of death among young New Zealanders under 45, with most deaths occurring before reaching a hospital. Consequently, pre-hospital interventions for limiting bleeding are of paramount importance. The PATCH-Trauma Study confirms the results of several prior studies — that TXA can stop bleeding and help save lives. However, this is the first study where the results indicate that TXA may be associated with a reduction in the survivor’s ability to lead an independent life.

Professor Paul Young, Deputy Director and Intensive Care Medicine lead at the MRINZ, and PATCH-Trauma Study author, describes this research as a milestone in trauma care. He emphasises the complexity of the predicament, stating, “This is an example of how science does not always provide us with simple answers. Individuals will have varying perspectives on whether surviving with severe disability is preferable to death.”

Given the critical condition of patients who could be given this medication, nuanced discussions regarding its use for individual decision-making at time of delivery are not practical. The findings of this study now require broad consultation so that differing views on the use of TXA can be accounted for when considering pre-hospital care policy.

Lead investigator Dr Colin McArthur, who led the PATCH-Trauma Study in New Zealand, underscores the collaborative nature of the trial, saying, "We highly value our frontline research partners in Hato Hone St John and Wellington Free Ambulance services, emergency departments, and intensive care units, working in tandem to best support patients and the healthcare system. This research was only possible with collaboration throughout the motu and around the world."

Associate Professor Bridget Dicker, Hato Hone St John Paramedic and Head of Clinical Audit and Research, commends the efforts of all paramedics in New Zealand who participated in the study, including road and air ambulance staff, staying, “The PATCH-Trauma Study shows paramedics’ dedication to conducting rigorous clinical trials under enormously challenging circumstances while caring for patients in a critical condition.”

Dr Tony Smith, Hato Hone St John Deputy Clinical Director, a clinician who enrolled some of the first patients into the study, and Dr Andy Swain, the Medical Director of Wellington Free Ambulance both acknowledge the significance of these results for study participants and their whānau throughout New Zealand. “Without the generous contribution of the participants and their families, the study simply could not have happened,” says Dr Swain.

The PATCH-Trauma study received endorsement from the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZIC-CTG), was approved by a New Zealand Health and Disability Ethics Committee, with funding from the New Zealand Health Research Council and the New Zealand Lottery Grants Board.

KEY POINTS AT A GLANCE

The PATCH-Trauma study, undertaken by intensive care, emergency medicine, and paramedic researchers in New Zealand, Australia, and Germany, was recently published in the New England Journal of Medicine, raising a challenging question — In the event of severe injury, is it preferable to survive but with severe disability, or not survive at all? 
 

The study examined the drug tranexamic acid (TXA), commonly used to limit bleeding during surgery, examining its effectiveness as a pre-emptive measure for patients at risk of life-threatening bleeding following trauma. 
 

The findings revealed that, on average, for every 100 patients who received TXA, there were four additional survivors at a six-month mark, but also four additional patients with severe disability requiring them to rely heavily on caregivers. 
 

TXA is currently part of the treatment provided by ambulance personnel throughout New Zealand for patients with bleeding associated with severe injuries. This study confirms the results of several prior studies: that TXA can help to save lives. However, this is the first study where the results indicate that TXA may be associated with a reduction in the survivor’s ability to lead an independent life. These results will require careful consideration by clinicians throughout New Zealand to consider any change to current treatment protocols. 
 

The results of the The Pre-hospital Antifibrinolytics for Traumatic Coagulopathy and Haemorrhage (PATCH-Trauma) Study were published in the New England Journal of Medicine on June 14. The paper was authored by 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, Veronica Pitt, Stephen Rashford, Michael C. Reade, Andrew H. Swain, Tony Trapani, and Paul J. Young. 
 

Here in New Zealand, the PATCH-Trauma study was underpinned by collaboration between the Medical Research Institute of New Zealand (MRINZ), Hato Hone St John, and Wellington Free Ambulance. 
 

The PATCH-Trauma study received endorsement from the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZIC-CTG), was approved by The New Zealand Northern A Health and Disability Ethics Committee 14/NTA/123 and received funding from the New Zealand Health Research Council and the New Zealand Lottery Grants Board.

###

TRIAL LINK: https://www.nejm.org/doi/full/10.1056/NEJMoa2215457

BIOS 
 

Medical Research Institute of New Zealand 
Rangahautia Te Ora

The Medical Research Institute of New Zealand (MRINZ) is Aotearoa New Zealand’s leading independent medical research institute. MRINZ research is guided by a simple philosophy: it must challenge dogma, increase knowledge, and have the potential to improve clinical practice and outcomes, both in Aotearoa New Zealand, and internationally. Committed to contributing toward a more equitable society that celebrates Te Ao Māori and upholds Te Tiriti o Waitangi, MRINZ’s research teams are dedicated to investigating important public health problems, delivering high quality evidence on which to improve the management of disease and patient care. 

Hato Hone St John 
Hato Hone St John provides emergency ambulance services to 90 percent of New Zealanders and covers 97 percent of the country’s geographical area. The organisation is made up of a mix of full-time paid employees and volunteer staff. Hato Hone St John has contracts with Te Whatu Ora Health New Zealand and ACC who fund approximately 90 percent of the operating costs for the ambulance service. The balance on what is required to run the service is made up from ambulance part charges, third-party contracts, and fundraising. Along with the emergency ambulance service, Hato Hone St John provides a significant number of community health programmes and initiatives which help build community resilience. They include Health Shuttles, Caring Caller, Friends of the Emergency Department, St John Youth, ASB St John in Schools, and Therapy Pets. Hato Hone St John also delivers event health services, medical alarm services, first aid training and operates retail stores across the country. 

Wellington Free Ambulance 
Wellington Free Ambulance is the only Emergency Ambulance Service for Greater Wellington and Wairarapa. They provide all services free of charge and operate 24 hours per day, 365 days per year. As well as providing Emergency Ambulance Services (52,000 incidents annually) Wellington Free also provides a Patient Transfer Service (46,000 transfers annually), has a specially trained Rescue Squad, and provides paramedic expertise on the regional rescue helicopter. The Clinical Communications Centre at Wellington Free Ambulance in Thorndon is one of three in New Zealand, answering emergency 111 calls, on average 245,000 calls annually. Wellington Free Ambulance Event Medics provide medical support at events across the region including sporting events, concerts, and festivals. They also teach lifesaving CPR skills to communities install and maintain AEDs across our region through the Lloyd Morrison Foundation Heartbeat programme. 

Professor Colin McArthur 
Colin McArthur is an intensive care medicine programme lead and senior research fellow at the MRINZ, and intensive care specialist in the Department of Critical Care Medicine, Auckland City Hospital. Graduating from Auckland University, he trained in both anaesthesia and intensive care medicine in New Zealand, the UK, and Hong Kong. He is a past Chair of the Australia and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group with over 25 years’ experience in investigator-led large-scale multicentre intensive care trials. In addition to being an active clinical trialist, Colin also leads research governance for New Zealand’s largest clinical research facility at Auckland City Hospital and holds honorary / adjunct appointments at Auckland University and Monash University, Melbourne. 

Professor Paul Young 
 

Paul Young is the deputy director of the MRINZ and intensive care medicine programme lead. An active member of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG), Paul is a leading member of the international intensive care research community. Paul is co-clinical leader of the Intensive Care Research Unit at Wellington Hospital, the Medical Director of the Wakefield Hospital ICU, and an active member of the Australian and New Zealand Intensive Care Society Clinical Trials Group. Paul is an Associate Professor at the University of Melbourne, an Adjunct Professor at Monash University, and the Associate Editor for the Critical Care and Resuscitation journal. Paul has published over 250 peer-reviewed journal articles. You can follow Paul’s clinical trial research on Twitter @DogICUma. 
 

Dr Andy Swain 
Andy Swain is the Medical Director of Wellington Free Ambulance and Associate Professor in Paramedicine at AUT. He works in the Emergency Department of Wellington Hospital, teaches ambulance staff, and is familiar with ambulance & helicopter environments. Andy has been involved with ambulance services and resuscitation since the 1980’s. He led the development of community paramedicine in the Wellington Region and flight paramedicine at Wellington’s Life Flight Trust. His research interests and publications are focused on out-of-hospital resuscitation and pre-hospital medicine. 

Associate Professor Bridget Dicker 
Bridget Dicker is the Head of Clinical Audit and Research for Hato Hone St John and concurrently serves as an Associate Professor at Auckland University of Technology. Bridget has made a significant contribution to the field of out-of-hospital emergency care with a focus on resuscitation. She developed and manages the New Zealand out-of-hospital cardiac arrest registry, which was established for research into epidemiological, or clinical factors that may contribute to improved outcomes. She is also a registered paramedic and continues to maintain her clinical practice alongside her academic role. 

Dr Tony Smith 
Tony Smith is one of the Deputy Clinical Directors for Hato Hone St John and helped provide clinical oversight of the PATCH-Trauma study. Tony is also an Intensive Care Medicine Specialist at Auckland City Hospital. He chairs the working group that develops the clinical procedures and guidelines for the emergency ambulance sector in New Zealand. He is actively involved in pre-hospital research, with a focus on a collaborative approach to contributing to multicenter trials. He is also a member of the helicopter emergency medical service in Auckland and has a very active hands-on role in pre-hospital care.

© Scoop Media