- Tranexamic acid reduced head injury-related mortality by 22% among patients with mild to moderate traumatic brain injury (TBI) treated within 3 hours.
Why this matters
- Intracranial bleeding after TBI increases risks for poor outcomes.
- Among the 72.2% of patients treated within 3 hours of injury, risk for head injury-related death with tranexamic acid vs placebo: 18.5% vs 19.8%.
- Risk ratio, 0.94 (95% CI, 0.86-1.02).
- Greater reduction after excluding patients with Glasgow Coma Scale score of 3 or bilateral unreactive pupils: 12.5% vs 14.0%.
- Risk ratio, 0.89 (95% CI, 0.80-1.00).
- By severity:
- Mild to moderate injury: risk ratio, 0.78 (95% CI, 0.64-0.95).
- Severe injury: risk ratio, 0.99 (95% CI, 0.91-1.07).
- Difference in benefit going from time to treatment of 0-240 minutes:
- Significant in mild and moderate head injury (P=.005).
- Not significant in severe head injury (P=.73).
- Tranexamic acid, placebo similar on risks for vascular occlusive events, seizures.
- In a Comment, Andrew P. Cap, MD, PhD, writes, "Despite its limitations, CRASH-3 is a remarkable study that will change practice, and tranexamic acid will benefit future patients with TBI who might reasonably have a chance of recovery from their injuries."
- Randomized controlled trial, 12,737 adults with TBI (CRASH-3 trial):
- ≤3 hours after injury (originally ≤8 hours).
- Glasgow Coma Scale score ≤12 or intracranial bleeding on CT scan.
- No major extracranial bleeding.
- Randomization: tranexamic acid vs placebo.
- Main outcome: in-hospital head injury-related death ≤28 days after injury in patients treated ≤3 hours after injury.
- Funding: National Institute for Health Research Health Technology Assessment; others.
- Wide confidence intervals.
- Possible missed thrombotic/embolic events.
- Inclusion of patients with unilateral unreactive pupils.