Traumatic Brain Injury (TBI) is a devastating condition with limited venues of pharmacological treatment that would improve outcomes. A new trial published in the Lancet [1] shows evidence of improved outcomes in TBI using Tranexamic acid.
This study was a international multicenter randomized placebo-controlled trial of Tranexamic acid administered within 3 hours of injury which included 12737 patients with TBI with a GCS of 12 or lower or any intracranial bleeding on CT scan. The study prespecified a sensitivity analysis that excluded patients with GCS 3 or with bilaterally fixed pupils considering the dire outcome in this group of patients regardless of treatment.
The study presents the data on 9127 patients which brings evidence that there is a statistically significant effect of Tranexamic acid (administered as a loading dose of 1g infused over 10 minutes followed by an intravenous infusion of 1 g over 8h) on head-injury related mortality in mild to moderate TBI but not in those with severe TBI without evidence of adverse effects or vascular occlusive events.
The study also showed there was a time to treatment interaction with the most benefit accrued in the group of patients treated the earliest but notably this effect was seen only in the group of patients with mild to moderate injury (GCS of 9 to 15).
The present trial is significant as it is one of the first pharmacological interventions to show evidence of benefit in the acute setting of TBI but also the limited time window which must be considered in future trials evaluating measures meant to control intracranial bleeding in TBI.
The CRASH-3 trial investigators provided evidence that Tranexamic acid may be beneficial when administered within 3 hours in patients with mild to moderate traumatic brain injury
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