Goal

The PATCH-Trauma Study is an international 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. The study aims 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
  • 1316 participants at high risk of acute traumatic coagulopathy
  • Pre-hospital treatment with tranexamic acid in advanced trauma systems
  • Mortality and functional recovery at six months
  • Assessment of fibrinolysis, coagulation, and thrombotic events

Statistical Analysis Plan

PATCH Statistical analysis plan v1.0 - 19th August 2022

Funding

Funded by the Australian Government National Health and Medical Research Council.

Participation of New Zealand sites is made possible by funding from the New Zealand Health Research Council and the New Zealand Lottery Grants Board.

Participation of Germany sites is made possible by the national research funding agency DFG (Deutsche Forschungsgemeinschaft MA 2569/6-1) - In Progress.

Endorsement

This study is endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZIC-CTG)

ClinicalTrials.gov Identifier: NCT02187120

*Gruen and Mitra. The Lancet 2011; Napolitano et al. J.Trauma Acute Care Surg. 2013; Pusateri et al. Shock 2013