Safety and Efficacy of Tranexamic Acid in Urologic Surgery: Results from the International, Randomized, Placebo-Controlled POISE-3 Trial

Authors

• Kari A O Tikkinen
• Maura Marcucci
• Alex L E Halme
• Sandra N Ofori
• Flavia K Borges
• Charlotte T B Kanstrup
• Lily J Park
• Farhad Tondroanamag
• Tuomas P Kilpeläinen
• Sara V Tornberg
• Thomas W Painter
• David Conen
• Vladimir Lomivorotov
• Daniel I Sessler
• Matthew T V Chan
• Maria Jose Martinez-Zapata
• Chew Y Wang
• Denis B Xavier
• Michael K Wang
• Wojciech Szczeklik
• Kate Leslie
• Luke T Lavallee
• Rodney H Breau
• Kumar Balasubramanian
• P J Devereaux

Language

English

Publication Date

8-1-2026

Journal

European Urology

DOI

10.1016/j.eururo.2026.03.019

PMID

42020258

Abstract

Background and objective: Perioperative bleeding is common. Evidence for tranexamic acid (TXA) in urology remains limited and conflicting, and major urologic guidelines provide no recommendations. In an a priori planned analysis, we evaluated TXA among patients undergoing urologic surgery in POISE-3.

Methods: POISE-3 was an international randomized trial of patients undergoing surgery with bleeding and cardiovascular risk factors. Participants received TXA (1 g intravenous bolus at surgery start and end) or placebo. The primary efficacy outcome was a 30-day bleeding composite (life-threatening/major/critical organ), and the primary safety outcome was a 30-day thrombosis composite (myocardial injury after noncardiac surgery [MINS], nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism [VTE]).

Key findings and limitations: Among 1124 urologic participants (556 TXA and 568 placebo), 489 had laparoscopic/robotic, 360 open, 244 transurethral, and 31 percutaneous surgery. The composite bleeding outcome occurred in 45 (8.1%) with TXA and in 62 (10.9%) with placebo (hazard ratio [HR] = 0.73, 95% confidence interval [CI] = 0.50-1.07). Major bleeding occurred in 34 (6.1%) with TXA and in 54 (9.5%) with placebo (HR = 0.63, 95% CI = 0.41-0.97). The composite safety outcome occurred in 67 (12.1%) with TXA and in 62 (10.9%) with placebo (HR = 1.12, 95% CI = 0.79-1.58; MINS: 62 vs 58; strokes: 2 vs 2; VTEs: 3 vs 3). We identified no interactions by surgical approach, cancer status, or recent antithrombotic usage. Patient-important thrombotic events were few, limiting precision for stroke and VTE estimates.

Conclusions and clinical implications: TXA reduced major bleeding and supports perioperative use in urologic surgery, especially when the bleeding risk is high.

Keywords

Humans, Tranexamic Acid, Antifibrinolytic Agents, Male, Urologic Surgical Procedures, Aged, Middle Aged, Female, Treatment Outcome, Postoperative Hemorrhage, Blood Loss, Surgical, Double-Blind Method, Antifibrinolytic agents, Blood loss, Blood transfusion, Cystectomy, Nephrectomy, Nephrolithotomy, Percutaneous, Prostatectomy, Stroke, Thrombosis, Transurethral resection of prostate

Published Open-Access

yes

Recommended Citation

Tikkinen, Kari A O; Marcucci, Maura; Halme, Alex L E; et al., "Safety and Efficacy of Tranexamic Acid in Urologic Surgery: Results from the International, Randomized, Placebo-Controlled POISE-3 Trial" (2026). Faculty, Staff and Student Publications. 1543.
https://digitalcommons.library.tmc.edu/uthsph_docs/1543