NCT01402882.

Trial name or title	Clinical Randomisation of an Antifibrinolytic in Significant Head Injury (CRASH‐3).
Methods	Large, international, randomised, placebo controlled trial.
Participants	Adults with traumatic brain injury, who are within eight hours of injury, with any intracranial bleeding on CT scan or who have a GCS of 12 or less, and have no significant extra‐cranial haemorrhage, are eligible for inclusion, except those for whom antifibrinolytic agents are thought to be clearly indicated or clearly contra‐indicated.
Interventions	Loading dose of tranexamic acid (1 gram by intravenous injection) or placebo (sodium chloride 0.9%) given as soon as possible after randomisation. Maintenance dose of tranexamic acid (1 gram by intravenous injection) or placebo (sodium chloride 0.9%) given after the loading dose is finished.
Outcomes	Primary outcome is death in hospital within 28 days of injury. Secondary outcomes are vascular occlusive events (myocardial infarction, pulmonary embolism, clinical evidence of deep vein thrombosis), stroke, disability, seizures, neurosurgical intervention, days in intensive care, other adverse events.
Starting date	July 2012
Contact information	crash@Lshtm.ac.uk
Notes	Current Controlled Trials ISRCTN15088122; Clinicaltrials.gov NCT01402882. The JP Moulton Charitable Trust, UK, is funding the run‐in costs for the trial and up to 500 patients’ recruitment. Full funding is being sought from public funding organisations for the main trial.