CRASH-3
Trial question
What is the effect of tranexamic acid in patients with acute traumatic brain injury?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 9202
9202 patients (1800 female, 7402 male).
Inclusion criteria: adult patients with traumatic brain injury who were within 3 hours of injury, had a GCS 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 traumatic brain injury.
Interventions
N=4649 tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 hours).
N=4553 placebo (0.9% sodium chloride by intravenous infusion).
Primary outcome
Rate of head injury-related death in hospital within 28 days of injury
18.5%
19.8%
19.8 %
14.9 %
9.9 %
5.0 %
0.0 %
Tranexamic
acid
Placebo
No significant
difference ↔
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 traumatic brain injury who were within 3 hours of injury, had a GCS 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.
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