ANZICS CTG Endorsed Study
Pre-hospital anti-fibrinolytics for traumatic coagulopathy and haemorrhage
The PATCH Trauma study aims to address whether early administration of tranexamic acid (TXA), compared to placebo, reduces mortality and improves recovery at six months in severely injured adults at risk of acute traumatic coagulopathy (ATC) who are treated in advanced trauma systems.
In 10-25% of severely injured patients, bleeding is exacerbated by ATC characterized by hyperfibrinolysis detectable on hospital arrival. Patients with ATC are 3-4 times more likely to die and develop multiple organ failure, and have longer intensive care and hospital stays. A large international study (CRASH-2) showed TXA reduced all-cause mortality in adult trauma patients with, or at risk of, significant haemorrhage. Almost all of the patients enrolled in CRASH-2 were treated in hospitals in low and middle income countries that have markedly different standards of care for the management of ATC, higher baseline mortality rates, and a younger patient population than trauma centres in Australia and New Zealand. A post-hoc analysis of the CRASH-2 trial results found there was an unexpected increase in the risk of death due to bleeding when TXA was given beyond three hours from injury.
The PATCH Trauma study is a multi-centre randomised, placebo-controlled and blinded study that will enroll 1184 severely injured patients at risk of ATC in the prehospital setting. Emergency medical services clinicians will assess patient eligibility using the coagulopathy of severe trauma (COAST) score. TXA or placebo will be administered in the prehospital and a second dose given soon after hospital arrival. The primary outcome of the study is the proportion of patients with a favourable outcome at six months (moderate disability to good recovery, GOSE scores 5-8) compared to those who have died (GOSE 1), or have severe disability (GOSE 2-4). Secondary outcomes include vascular occlusive events (AMI, stroke, DVT, PE), blood product use, 24 hour and 28 day mortality, and the effects of TXA on coagulation, fibrinolysis and inflammatory mediators.
Stephen Bernard (Chair), Mark Bailey, Ann-Marie Baker, Zsolt Balogh, Camila Battistuzzo (Project Manager), Jasmin Board, Brian Burns, Peter Cameron, Rosemary Carney, Grant Christey, Jamie Cooper, Natasha Dodge, Mark Fitzgerald, Andrew Forbes, Dashiell Gantner, Russell Gruen, Malcolm Johnston-Leek, Maija Kaukonen, Stefan Mazur, Colin McArthur, Robert Medcalf, Biswadev Mitra, Sandy Muecke, Lynne Murray, Paul Myles, Veronica Pitt, Stephen Rashford, Michael Reade, Tony Smith, Andy Swain, Huyen Tran and Paul Young.
ANZIC Research Centre, Monash University
NHMRC Project Grant $1,668,152.46
NZ Lottery Grants Board Translational Research Project $60,000.00
Intensive Care Foundation Research Grant $38,350.00
Health Research Council of New Zealand NZ$943,384
NHMRC Project Grant $656,155.00
Project Status as of June 2019
The PATCH study has enrolled approximately 74% of the target cohort of 1184 as end of June 2019. In the past 12 months the average monthly enrolments increased from 20 to 23 per month. At the current rate of enrolment, recruitment is expected to be completed by August 2020 and the study by early 2021. This increase in the monthly enrolments is due to the nine new sites activated in 2018-19. There are 32 sites across Australian and New Zealand, incorporating ambulance/retrieval services and major trauma centres participating on PATCH.
The second interim analysis was submitted to the DSMC in December 2018 and there was unanimous agreement to continue the study.
The second NHMRC grant application (PATCH II) was successful. The grant will provide funding from January 2019 to December 2021 and it will be crucial for the successful completion of the trial across Australia.
NCT02187120 (Clinicaltrials.gov ID)