6/28/23, 12:22 AM CRASH-3 Pathway Feedback Search Clinical Topics Home Studies CRASH 3 CRASH 3 Disease Traumatic brain injury Trial question What is the effect of tranexamic acid in patients with acute TBI? Study design Multi-center Double blinded RCT Population Characteristics of study participants 20.0% female N = 9202 80.0% male 9202 patients (1799 female, 7402 male) Inclusion criteria: adult patients with TBI who were within 3 hours of injury, had a Glasgow Coma Scale score 12 or any intracranial bleeding on CT scan, and no major extracranial bleeding Key exclusion criteria: the responsible clinician's 'uncertainty' as to the appropriateness of tranexamic acid treatment in a particular patient with TBI Interventions N=6406 tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 hours) N=6331 placebo (0.9% sodium chloride by intravenous infusion) Primary outcome Rate of head injury-related death in hospital within 28 days of injury 19.8 % 19.8 18.5 14 9 % https://web.pathway.md/studies/rec6awzUz1qIKQ0yZ 1/2 6/28/23, 12:22 AM 14.9 % CRASH-3 Pathway 9.9 % 5.0 % No significant difference 0.0 % Tranexamic acid Placebo No significant difference in the rate of head injury-related death in hospital within 28 days of injury (18.5% vs. 19.8%; RR 0.94, 95% CI 0.86 to 1.02) Secondary outcomes Significant decrease in mild-to-moderate head injury-related death (5.8% vs. 7.5%; RR 0.78, 95% CI 0.64 to 0.95) Significant decrease in head injury-related death among patients with reactive pupils (11.5% vs. 13.2%; RR 0.87, 95% CI 0.77 to 0.98) No significant difference in severe head injury-related death (39.6% vs. 40.1%; RR 0.99, 99% CI 0.91 to 1.07) Safety outcomes No significant differences in risk of vascular occlusive events, seizures, and stroke. Conclusion In adult patients with TBI who were within 3 hours of injury, had a Glasgow Coma Scale score 12 or any intracranial bleeding on CT scan, and no major extracranial bleeding, tranexamic acid was not superior to placebo with respect to the rate of head injury-related death in hospital within 28 days of injury. Reference CRASH- trial collaborators. Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial. Lancet. 2019 Nov 9;394(10210):1713-1723. Open reference URL https://web.pathway.md/studies/rec6awzUz1qIKQ0yZ 2/2