April Virtual Journal Club – Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT)

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CRASH-3 Trial

CRASH-3 Trial3

  • Published in the Lancet in 2019, this study aimed to assess the effects of TXA in patients with traumatic brain injury (TBI).
  • This was a randomised, placebo-controlled, triple-blinded trial undertaken in 175 hospitals in 29 countries. Adults with TBI within 3 h of injury, with a Glasgow Coma Scale (GCS) score of 12 or lower or any intracranial bleeding on CT scan, and no major extracranial bleeding were eligible.
  • Patients were randomly assigned (1:1) patients to receive TXA (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo.
  • The primary outcome was head injury-related death in hospital within 28 days of injury in patients treated within 3 h of injury.
  • 12,737 patients with TBI were randomised, 6406 in TXA group [50.3%] and 6331 in placebo group [49.7%], of whom 9202 (72.2%) patients were treated within 3 h of injury.
  • The risk of head injury-related death reduced with TXA in patients with mild-to-moderate head injury (RR 0.78 [95% CI 0.64-0.95]) but not in patients with severe head injury (0.99 [95% CI 0.91-1.07]; p value for heterogeneity 0.030).
  • Early treatment was more effective than later treatment in patients with mild and moderate head injury (p=0.005) but time to treatment had no obvious effect in patients with severe head injury (p=0.73).
  • The risk of vascular occlusive events was similar in the TXA and placebo groups (RR 0.98 (0.74-1.28). The risk of seizures was also similar between groups (1.09 [95% CI 0.90-1.33]).