CRASH-3 [Version 1.0]
Research type
Research Study
Full title
Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial.
IRAS ID
88262
Contact name
Ian Roberts
Eudract number
2011-003669-14
ISRCTN Number
ISRCTN15088122
Clinicaltrials.gov Identifier
Research summary
Worldwide, over 10 million people are killed or hospitalised because of traumatic brain injury (TBI) each year. The social and economic burden of TBI is considerable. Systemic tranexamic acid (TXA) is widely used in surgery. A systematic review of randomised controlled trials of TXA in surgical patients shows that TXA reduces the number of patients receiving a blood transfusion by about a third. Recently, the CRASH-2 trial showed that administration of TXA significantly reduces deaths due to traumatic bleeding. Two pilot studies have evaluated the effect of TXA in TBI. Meta-analysis of the two trials shows a significant reduction in haemorrhage growth and mortality with TXA. However, the estimates are imprecise and there are no data on the effect of TXA on vascular occlusive events and disability. The CRASH-3 trial is an international, multi-centre, randomised placebo controlled trial of the effects of early administration of TXA on death, disability and vascular occlusive events in adult patients with TBI. A total of 10,000 adult TBI patients who fulfil the eligibility criteria will be randomised to receive either TXA or matching placebo. Adults with TBI, who are within eight hours of injury, with any intracranial bleeding on CT scan or who have a Glasgow Coma Score (GCS) of 12 or less, and do not require immediate blood transfusion for extra-cranial bleeding, are eligible for inclusion. The fundamental eligibility criterion is the doctor??s ??uncertainty?? as to whether or not to use TXA in a particular TBI patient. A loading dose of 1 gram TXA will be followed by a 1 gram maintenance dose over eight hours. In-hospital deaths, disability and complications will be assessed at death, hospital discharge, or 28 days following randomisation, whichever occurs first.
REC name
East of England - Essex Research Ethics Committee
REC reference
12/EE/0274
Date of REC Opinion
19 Jul 2012
REC opinion
Favourable Opinion