NCT01990768.

Trial name or title	Prehospital Tranexamic Acid Use for Traumatic Brain Injury.
Methods	Randomised, placebo controlled trial.
Participants	Adult (≥15 years) patients with moderate to severe TBI. Setting: USA (two western states ‐ Oregon and Washington)
Interventions	Group 1) Loading dose of tranexamic acid (1 gram by intravenous injection) given prior to hospital arrival followed by maintenance dose (1 gram by intravenous injection) over 8 hours after hospital arrival. Group 2) Loading dose of tranexamic acid (2 gram by intravenous injection) given prior to hospital arrival followed by placebo maintenance dose over 8 hours after hospital arrival. Group 3) Placebo loading dose given prior to hospital arrival followed by placebo maintenance dose over 8 hours after hospital arrival.
Outcomes	Primary outcome is disability as measure by GOS‐E score (Sander 2002) at six months after injury. Secondary outcomes are volume of intracranial haemorrhage, Disability Rating Scale, death, neurosurgical intervention, ventilator‐free days, seizures, cerebral ischaemic events, myocardial infarction, pulmonary embolism, deep vein thrombosis, alterations in fibrinolysis.
Starting date	June 2014
Contact information	Susanne May, PhD (sjmay@uw.edu)
Notes	Clinicaltrials.gov NCT01990768. Total sample size is 1002 (334 per group).