ANZICS CTG Endorsed Study
The PATCH Study
Pre-hospital anti-fibrinolytics for traumatic coagulopathy and haemorrhage
Study Description
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 1316 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.
Management Committee
Stephen Bernard (Chair), Biswadev Mitra, Russell Gruen, Robert Medcalf, Michael Reade, Huyen Tran, Andrew Forbes, Paul Myles, Peter Cameron, Mark Fitzgerald, Stephen Rashford, Brian Burns, Tony Smith, Grant Christey, Zsolt Balogh, Lynne Murray, Maija Kaukonen, Stefan Mazur, Ann-Marie Baker, Andy Swain, Paul Young, Mark Bailey, Dashiell Gantner, Jasmin Board, Phoebe Mccracken, Colin McArthur, Sally Hurford, Camila Battistuzzo, Nicole Ng, Marc Maegele
Administering Institution
ANZIC RC
Sample Size
1316 patients
Funding
NHMRC, NZ Lottery Grants Board, Intensive Care Foundation, NZ HRC, NHMRC, Deutsche Forschungsgemeinschaft
Reference
CTG1314-005, NCT02187120
Contact
Stephen Bernard (email)
Nicole Ng (email)