The CRASH-3 trial is being conducted to assess the effect of tranexamic acid on risk of death or disability in patients with Traumatic Brain Injury (TBI). TBI can cause bleeding in the brain. If left to continue, it can create pressure that can lead to further damage that will result in death or permanent disability. By conducting this trial we are collecting important evidence to help determine i
f tranexamic acid is an effective treatment for patients with TBI. OUTCOME:
PRIMARY OUTCOME: The primary outcome is death in hospital within 28 days of injury among patients randomised within 3 hours of injury (cause-specific mortality will also be recorded). SECONDARY OUTCOMES:
(a) Vascular occlusive events (myocardial infarction, pulmonary embolism, clinical evidence of deep vein thrombosis)
(b) Stroke
(c) Disability assessed using the Disability Rating Scale and Patient Orientated Outcome measures
(d) Seizures
(e) Neurosurgical intervention
(f) Days in intensive care
(g) Other adverse events
TRIAL DESIGN: A pragmatic, randomised, double blind placebo controlled trial among 13,000 traumatic brain injury patients
The CRASH-3 trial is inspired by the results of the CRASH-2 trial. The CRASH-2 trial showed that tranexamic acid, an affordable and heat stable drug, reduced death due to bleeding and had the most beneficial effect when administered as soon as possible after injury.
