TBI: prehospital tranexamic acid does not improve 6-month outcomes

  • Rowell SE & al.
  • JAMA
  • 8 Sep 2020

  • curated by Jenny Blair, MD
  • Clinical Essentials
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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

  • TA is often used to treat severe hemorrhagic shock.
  • CRASH-3 (n=12,737) found no mortality difference with TA bolus vs placebo.
  • Editorial : results "provide support for a large effectiveness trial."

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).
  • 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.