CRASH-2
Trial question
What is the effect of tranexamic acid in trauma patients with significant hemorrhage?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
16.0% female
84.0% male
N = 20207
20207 patients (3272 female, 16935 male).
Inclusion criteria: adult trauma patients with, or at risk of, significant bleeding.
Key exclusion criteria: a clear indication for tranexamic acid, or a clear contraindication to tranexamic acid treatment.
Interventions
N=10093 tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h IV).
N=10114 placebo (matching placebo of 0.9% saline IV).
Primary outcome
All-cause death
14.5%
16%
16.0 %
12.0 %
8.0 %
4.0 %
0.0 %
Tranexamic
acid
Placebo
Significant
decrease ▼
NNT = 66
Significant decrease in all-cause death (14.5% vs. 16%; RR 0.91, 95% CI 0.85 to 0.97).
Secondary outcomes
Significant decrease in death due to bleeding (4.9% vs. 5.7%; RR 0.85, 95% CI 0.76 to 0.96).
No significant difference in death due to vascular occlusion (0.3% vs. 0.5%; RR 0.9, 95% CI 0.75 to 1.08).
No significant difference in vascular occlusive events (1.7% vs. 2%; RR 0.84, 95% CI 0.68 to 1.02).
Conclusion
In adult trauma patients with, or at risk of, significant bleeding, tranexamic acid was superior to placebo with respect to a all-cause death.
Reference
CRASH- trial collaborators, Shakur H, Roberts I et al. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32.
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