NCT02187120.

Trial name or title	Pre‐hospital Anti‐fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study).
Methods	Randomised, placebo controlled trial.
Participants	Adult patients (age ≥18 years); injured through any mechanism; COAST score≥3. Setting: Australia (Victoria)
Interventions	1g TXA or placebo (0.9% NaCl) by slow intravenous injection as early as possible following injury. Soon after arrival to the emergency department, patients will be given 1g TXA or placebo infused intravenously for 8 hours.
Outcomes	Primary: 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: Units of blood products used in the first 24 hours (packed red blood cells, fresh frozen plasma, platelets, prothrombin complex concentrate, Factor VIIa, cryoprecipitate); Coagulation profile (INR, APTT, D‐Dimer, platelet count); ICU ventilator‐free days in first 28 days; Vascular occlusive events (myocardial infarction, stroke, DVT, PE); Mortality; Proportion of deaths due to: bleeding, vascular occlusion (PE, stroke or acute myocardial infarction), multi‐organ failure and head injury; Cumulative incidence of sepsis at 28 days or hospital discharge whichever occurs first; Severity of chronic pain 6 months after injury and its interference with daily activities measured using the modified Brief Pain Inventory; Quality of life (SF12® and EQ5D) at 6 months.
Starting date	July 2014
Contact information	Veronica Pitt, PhD (veronica.pitt@monash.edu) http://patchtrauma.org/
Notes	Total planned sample size is 1184.