Out-of-Hospital Tranexamic Acid for Traumatic Brain Injury.

In this issue of JAMA, Rowell and colleagues from the Resuscitation Outcomes Consortium report findings from a randomized clinical trial of out-of-hospital administration of the antifibrinolytic agent tranexamic acid for patients with moderate or severe traumatic brain injury (TBI; defined as out-of-hospital Glasgow Coma Scale [GCS] score ≤12) and systolic blood pressure of at least 90 mm Hg.1 The study randomized patients to 3 treatment groups in which patients received either a 1-g tranexamic acid out-of-hospital bolus and 1-g in-hospital infusion over 8 hours (bolus maintenance group), a 2-g tranexamic acid out-of-hospital bolus and placebo infusion (bolus only group), or placebo bolus and placebo infusion (placebo group). The preplanned primary analysis compared the combined tranexamic acid treatment groups (n = 657) vs the placebo group (n = 309). There was no significant difference in the primary end point of favorable neurologic outcome at 6 months, defined as a Glasgow Outcome Scale-Extended score greater than 4 (65% of patients in the tranexamic acid group vs 62% in the placebo group; difference, −3.5% [90% 1-sided confidence limit for benefit, −0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). In addition, no significant differences between the combined tranexamic acid group vs the placebo group were identified in the secondary end points of 28-day all-cause mortality (14% vs 17%; adjusted difference, −2.9% [95% CI, −7.9% to 2.1%]), 6-month Disability Rating Scale score (6.8 vs 7.6; adjusted difference, −0.9; [95% CI, −2.5 to 0.7]), or progression of intracranial hemorrhage (ICH; 16% vs 20%; adjusted difference, −5.4% [95% CI, −12.8% to 2.1%]). [Opening paragraph]