Takeaway
- This trial found no benefit of tranexamic acid (TA) on neurologic outcomes of patients with traumatic brain injury (TBI) at the 6-month mark.
Why this matters
Key results
- TA groups vs placebo (n=819 at 6-month follow-up):
- Primary outcome: 65% vs 62%.
- 90% CL for benefit: −0.9% (P=.16).
- 97.5% CL for harm: 10.2% (P=.84).
- No significant differences in 28-day mortality, 6-month disability, progression of intracranial hemorrhage (ICH).
- Primary outcome: 65% vs 62%.
- Exploratory analyses: potential differences between regimens, more vs less severely injured patients.
Study design
- Double-blind, 3-group, randomized, phase 2 clinical TXA trial at 20 North American centers (n=966).
- Patients age ≥15 years with moderate to severe TBI were randomly assigned to receive, within 2 hours of injury:
- Out-of-hospital TA bolus plus maintenance,
- Out-of-hospital TA bolus plus placebo infusion, or
- Placebo bolus and infusion.
- Outcomes: 6-month favorable neurologic function of both TA groups vs placebo.
- Funding: National Heart, Lung, and Blood Institute.
Limitations
- Early mortality difference may have caused survival bias.
- Compared with CRASH-3, fewer enrollees had ICH.
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