Long-Term Outcomes of Trauma Patients After Treatment With Prehospital Tranexamic Acid: A Subgroup Analysis From the PATCH-Trauma Trial.

OBJECTIVES

The aim of this study was to assess 24-month functional outcomes of patients randomly assigned to prehospital tranexamic acid (TXA) compared with those assigned to placebo.

METHODS

The PATCH-Trauma trial assessed administration of TXA by prehospital clinicians and demonstrated greater survival at 28 days from injury among patients allocated to receive TXA, but no difference in favorable functional outcomes at 6 months.This was a subgroup analysis of patients enrolled in the PATCH-Trauma trial. The primary outcome measure was the 8-point Glasgow Outcome Scale-Extended (GOS-E) at 24 months after injury, dichotomized to favorable functional outcomes (GOS-E 5-8) and dead or unfavorable functional outcomes (GOS-E 1-4). We also assessed mortality at 24 hours, 28 days, 6 months, and 24 months after injury.

RESULTS

There were 584 patients eligible for inclusion, and 516 patients had data on 24-month outcomes available. Baseline characteristics were comparable. At 24 months, a favorable outcome was reported in 167 (64.0%; 95% CI: 57.8-69.8) patients in the TXA group and 149 (58.4%; 95% CI: 52.1-64.5) in the placebo group (P = .20). There was no difference in the change in GOS-E profile from 6 to 24 months (coeff -0.06; 95% CI: -0.30 to 0.19; P = .64). There was no difference in mortality at any timepoint.

CONCLUSION

Prehospital treatment and ongoing hospital infusion of TXA did not result in improved survival or statistically significant functional outcomes at 24 months compared to placebo. Consideration of longer-term outcomes after trauma is recommended for evidence to practice decisions.