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

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

Shimena R Li  1 , Francis Guyette  2 , Joshua Brown  1   3 , Mazen Zenati  1   3 , Katherine M Reitz  1 , Brian Eastridge  4 , Raminder Nirula  5 , Gary A Vercruysse  6 , Terence O'Keeffe  6 , Bellal Joseph  6 , Matthew D Neal  1   3 , Brian S Zuckerbraun  1   3 , Jason L Sperry  1   3
Affiliations
Clinical Trial

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

Shimena R Li et al. Ann Surg. .

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.

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Conflict of interest statement

The authors report no conflicts of interest.

Figures

Figure 1.
Figure 1.
Patient Selection Flowchart
Figure 2.
Figure 2.
Unadjusted Kaplan-Meier Survival Analysis for 24-hour and 30-day Survival Comparing Prehospital TXA and Placebo Patients for EARLY (A, C) and DELAYED (B, D) Subgroups P values were calculated using log-rank testing.
See this image and copyright information in PMC

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