Written by Clay Smith
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Prehospital TXA did not benefit patients with moderate to severe traumatic brain injury.
Why does this matter?
CRASH-2 showed lower mortality from bleeding in trauma patients. CRASH-3 showed a slight 28-day mortality benefit in traumatic brain injury (TBI) patients with a GCS ≥9, especially in the subgroup to whom TXA was given early. With that thought, the authors wondered if it might be of even greater benefit if given pre-hospital.
Sooner was not better
This was a multicenter, multifactorial RCT with 966 patients ≥15* years with head injury, GCS ≤12, without hypotension who were included in the final analysis. There were 3 groups: TXA 1gm bolus prehospital and 1gm over the next 8h in-hospital; TXA 2gm prehospital bolus and placebo over the next 8h in-hospital; all placebo. For the primary outcome of favorable neurological outcome at 6 months, there was no benefit to the combined TXA groups vs placebo, 65% vs. 62%, respectively; adjusted difference 3.5% (-0.9% lower 1-sided 90% confidence limit). There was also no benefit in 28-day mortality or other secondary outcomes. There did not appear to be an increase in harm with TXA, such as seizure or arterial or venous thrombosis. There are a few concerns with this study. There was large loss to follow up at 6 months, with 15% of patients unavailable. GCS may be depressed from injury or a lot of other reasons, like intoxication. Only ~58% of patients actually had ICH, which may have muted the effectiveness of TXA. In a nutshell, TXA for bad head injury, even when given very early, does not appear to help.
Source
Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury. JAMA. 2020 Sep 8;324(10):961-974. doi: 10.1001/jama.2020.8958.
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*This post has been corrected. It initially said “≤15 years.” Thanks to our savvy readers who caught this mistake and sent numerous emails within minutes this morning to alert us to the error. Who says blogs aren’t peer reviewed? This one has 16,000 peers who review it every morning!
All the TXA studies have shown very large NNTs. Even TICH failed to show benefit despite thousands of patients (there were other issues as well). It seems very unrealistic to imagine 966 patients could possibly show a statistically signifanct result..