PATCH Study
PATCH: Pre-Hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage
A multi-centre randomised, double-blind, placebo-controlled trial of pre-hospital treatment with tranexamic acid for severely injured patients at risk of acute traumatic coagulopathy.
Goal
To determine the effects of early administration of tranexamic acid on survival and recovery of severely injured patients treated within advanced trauma systems.
Rationale
Bleeding is the most common preventable cause of death following severe injury. Up to a quarter of severely injured patients develop a condition known as acute traumatic coagulopathy that is observed shortly after injury and is associated with excessive clot breakdown and increased mortality. Bleeding is exacerbated by early-onset clotting defects, which are associated with high mortality. Tranexamic Acid (TXA) has been shown to reduce mortality due to bleeding when given in hospital, but its usefulness as a pre-emptive strike at the scene of an injury in the context of advanced trauma systems is unknown.
Civilian and military experts have argued that a prospective randomised study performed in a controlled environment with laboratory monitoring of coagulation and standardised transfusion protocols is essential before TXA becomes standard of care in trauma.*
The PATCH-Trauma Study will contribute new knowledge on the early administration of TXA for severely injured patients treated in advanced trauma systems.
Overview
- International multi-centre, double-blind, randomised, placebo-controlled trial
- 1310 participants recruited
- Pre-hospital treatment with tranexamic acid in advanced trauma systems
- Mortality and functional recovery at six months
- Assessment of fibrinolysis, coagulation, and thrombotic events
Study Progress
Patient recruitment commenced in 2014 and completed in September 2020.
- 1st Interim Analysis (25% + 6 month follow-up) was November 2017. DSMC supported continuation of study.
- 2nd Interim Analysis (50% + 6 month follow-up) was November 2018. DSMC supported continuation of study.
Endorsement
The PATCH Study was endorsed by the Australian and New Zealand Intensive Care Clinical Trials Group (ANZICS-CTG).
Funding
The PATCH Study was funded by the NHMRC, New Zealand Health Research Council, New Zealand Lottery Grants Board and DFG (Deutsche Forschungsgemeinschaft).
Trial Registration
ClinicalTrials.gov Identifier NCT02187120
Contact
For further information about this study, please contact Nicole Ng by email.
Protocol
DSMC Charter
Publications
Reade MC, Pitt V, Gruen RL. Tranexamic acid and trauma: current status and knowledge gaps with recommended research priorities. Shock. 2013 Aug;40(2):160-1. doi: 10.1097/SHK.0b013e31829ab240.
Gruen RL, Jacobs IG, Reade MC; PATCH-Trauma study. Trauma and tranexamic acid. Med J Aust. 2013 Sep 2;199(5):310-1. doi: 10.5694/mja13.10747.
Mitra B, Mazur S, Cameron PA, Bernard S, Burns B, Smith A, Rashford S, Fitzgerald M, Smith K, Gruen RL; PATCH-Trauma Study Investigators. Tranexamic acid for trauma: filling the 'GAP' in evidence. Emerg Med Australas. 2014 Apr;26(2):194-7. doi: 10.1111/1742-6723.12172.
Mitra B, Bernard S, Gantner D, PATCH-Trauma study investigators, et al. Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial. BMJ Open. 2021 Mar 15;11(3):e046522. doi: 10.1136/bmjopen-2020-046522.
PATCH SAP V1.0. Uploaded 19 Aug 2022.
Trial Management
Australia: Russell Gruen (Principal Investigator), Stephen Bernard (PI- Australia), Biswadev Mitra, Dashiell Gantner, Robert Medcalf, Michael Reade, Huyen Tran, Andrew Forbes, Brian Burns, Jamie Cooper, Mark Fitzgerald, Paul Myles, Peter Cameron, Stephen Rashford, Zsolt Balogh
New Zealand: Colin McArthur (PI- New Zealand), Paul Young, Grant Christey, Ross Freebairn, Alex Kazemi, Tony Smith, Andrew Swain,
Germany: Marc Maegele (PI-Germany)
*Gruen and Mitra. The Lancet 2011; Napolitano et al. J.Trauma Acute Care Surg. 2013; Pusateri et al. Shock 2013.