Tranexamic acid within three hours of injury reduces head injury-related death, according to results from the groundbreaking Clinical Randomisation of an Antifibrinolytic in Significant Head Injury (CRASH-3) trial.
The randomised, placebo-controlled trial was carried out in 175 hospitals in 29 countries and recruited adults with traumatic brain injury (TBI) who were within three hours of injury, with a Glasgow Coma Scale (GCS) score of ≥12 or any intracranial bleeding on computed tomography scan and no major extracranial bleeding. Participants were randomly assigned 1:1 to receive tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over eight hours) or matching placebo.
Between 20 July 2012 and 31 Jan 2019, 12,737 patients with TBI were allocated to receive tranexamic acid (n=6406) or placebo (n=6331), of whom 9202 (72.2%) were treated within three hours of injury.
Among patients treated within three hours of injury, the risk for head injury-related death was 18.5 per cent in the tranexamic acid group versus 19.8 per cent in the placebo group (risk ratio [RR], 0.94; 95% CI, 0.86-1.02).
In the pre-specified sensitivity analysis that excluded patients with a GCS score of three or bilateral unreactive pupils at baseline, the risk for head injury-related death was 12.5 per cent with tranexamic acid versus 14.0 per cent with placebo (RR, 0.89; 95% CI, 0.80-1.00).
The risk for head injury-related death reduced with tranexamic acid in patients with mild-to-moderate head injury (RR, 0.78; 95% CI, 0.64-0.95) but not in patients with severe head injury (RR, 0.99; 95% CI, 0.91-1.07; Pfor heterogeneity=.030).
The risks for vascular occlusive events and seizures were similar between groups (RR, 0.98; 95% CI, 0.74-1.28 and RR, 1.09; 95% CI, 0.90-1.33, respectively).
The authors recommend that patients with TBI should be treated with tranexamic acid as soon as possible after injury.