Early Prehospital Tranexamic Acid Following Injury Is Associated With a 30-day Survival Benefit: A Secondary Analysis of a Randomized Clinical Trial

Ann Surg. 2021 Sep 1;274(3):419-426. doi: 10.1097/SLA.0000000000005002.

Abstract

Objective: We sought to characterize the timing of administration of prehospital tranexamic acid (TXA) and associated outcome benefits.

Background: TXA has been shown to be safe in the prehospital setting post-injury.

Methods: We performed a secondary analysis of a recent prehospital randomized TXA clinical trial in injured patients. Those who received prehospital TXA within 1 hour (EARLY) from time of injury were compared to those who received prehospital TXA beyond 1 hour (DELAYED). We included patients with a shock index of >0.9. Primary outcome was 30-day mortality. Kaplan-Meier and Cox Hazard regression were utilized to characterize mortality relationships.

Results: EARLY and DELAYED patients had similar demographics, injury characteristics, and shock severity but DELAYED patients had greater prehospital resuscitation requirements and longer prehospital times. Stratified Kaplan-Meier analysis demonstrated significant separation for EARLY patients (N = 238, log-rank chi-square test, 4.99; P = 0.03) with no separation for DELAYED patients (N = 238, log-rank chi-square test, 0.04; P = 0.83). Stratified Cox Hazard regression verified, after controlling for confounders, that EARLY TXA was associated with a 65% lower independent hazard for 30-day mortality [hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.19-0.65, P = 0.001] with no independent survival benefit found in DELAYED patients (HR 1.00, 95% CI 0.63-1.60, P = 0.999). EARLY TXA patients had lower incidence of multiple organ failure and 6-hour and 24-hour transfusion requirements compared to placebo.

Conclusions: Administration of prehospital TXA within 1 hour from injury in patients at risk of hemorrhage is associated with 30-day survival benefit, lower incidence of multiple organ failure, and lower transfusion requirements.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Antifibrinolytic Agents / administration & dosage*
  • Blood Transfusion / statistics & numerical data
  • Double-Blind Method
  • Emergency Medical Services*
  • Female
  • Hemorrhage / mortality
  • Hemorrhage / prevention & control*
  • Humans
  • Injury Severity Score
  • Male
  • Middle Aged
  • Multiple Organ Failure / mortality
  • Shock, Hemorrhagic / drug therapy
  • Survival Analysis
  • Time Factors
  • Tranexamic Acid / administration & dosage*

Substances

  • Antifibrinolytic Agents
  • Tranexamic Acid