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 1200 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, 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 (Project Manager), 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
Intensive Care Foundation Research Grant $38,350
Health Research Council of New Zealand NZ$943,384
Project Status as of June 2018
The PATCH study has enrolled approximately half the target cohort of 1184 patients as of June 2018. A planned interim analysis was conducted at 25% enrolment and the DSMC were in unanimous agreement for the study to continue. A second planned interim analysis is imminent (50% enrolment). There are 25 participating sites across Australia and New Zealand, incorporating ambulance and retrieval services and major trauma centres in VIC, SA, NSW, QLD, NT and NZ. Site activations are continuing in NSW and Tasmania and international sites are being sought.
NCT02187120 (Clinicaltrials.gov ID)