POISE-3: Tranexamic Acid Reduces Major Bleeding in Urological Surgery by 37%

KEY FINDINGS

• Trial: The a priori planned urological surgery analysis of the POISE-3 trial was published in European Urology; the data were first presented at the AUA 2026 congress.
• Number of patients: 1,124 urological patients were randomized - 556 to tranexamic acid (TXA), 568 to placebo.
• Major bleeding: 6.1% with TXA versus 9.5% with placebo (HR 0.63; 95% CI 0.41-0.97) - an absolute risk reduction of 3.4% and a relative reduction of approximately 37%.
• Composite bleeding (primary efficacy): 8.1% versus 10.9% (HR 0.73; 95% CI 0.50-1.07).
• Composite thrombosis (primary safety): 12.1% versus 10.9% (HR 1.12; 95% CI 0.79-1.58) - no significant difference.
• Patient-important events: Rare in both arms - 2 strokes and 3 symptomatic proximal VTEs in each.

Background: A Long-Unanswered Question in Urology

Tranexamic acid is an agent that inhibits fibrinolysis, has been in use for decades and is extremely low cost. Supported by strong evidence in trauma (CRASH-2), obstetric haemorrhage (WOMAN) and orthopaedic surgery, this molecule has interestingly not been systematically adopted in urological surgery. This hesitation has three main sources:

• Insufficient and inconsistent evidence: Most existing urology-specific studies were small, single-centre or open-label; the results conflicted with one another.
• Concern about clot retention: The worry that antifibrinolytic use in the urinary tract could lead to clot tamponade and obstruction in the bladder has limited its use, particularly in transurethral procedures.
• Concern about thromboembolic risk: Urological oncological surgery is already an area carrying a high VTE risk, and the assumption that adding an antifibrinolytic would increase this risk is widespread.

For this reason the EAU and AUA guidelines contain no clear recommendation on routine TXA use in urological surgery. This analysis, led by Professor Kari A. O. Tikkinen of the University of Helsinki, was designed precisely to fill this gap.

Study Design

POISE-3 (PeriOperative ISchemic Evaluation-3) is an international, double-blind, randomized controlled trial comparing TXA with placebo in patients undergoing non-cardiac surgery who carry bleeding and cardiovascular risk factors. The main trial was conducted at more than 100 centres in 22 countries.

Key Results

TXA: tranexamic acid; MINS: myocardial injury after non-cardiac surgery; VTE: venous thromboembolism; HR: hazard ratio; CI: confidence interval

Interpretation of the Findings

While the reduction in the composite bleeding endpoint narrowly failed to cross the threshold of statistical significance (the upper bound of the confidence interval was 1.07), the 37% relative risk reduction achieved in major bleeding is statistically significant and largely driven by a fall in the need for transfusion.

On the safety side, the numerical increase in the composite thrombosis endpoint is driven predominantly by a biochemically defined component such as MINS; the events that genuinely matter to patients - stroke and VTE - remained at the level of only 2-3 cases in each arm. Although the small number of events makes these estimates statistically imprecise, the fact that the trial did not exclude high-risk patients makes the absence of a safety signal more clinically meaningful.

Implications for Clinical Practice

1. Risk-based patient selection is essential

The absolute benefit of TXA is directly proportional to the patient's baseline bleeding risk. Radical cystectomy, open/robotic partial nephrectomy, large-volume prostate surgery, PCNL and patients on antithrombotic therapy are the groups in which the greatest gain is expected. The rationale for routine use in short, low-bleeding-risk procedures is weaker.

2. Concern about clot retention is not supported by evidence

The absence of a significant interaction in efficacy or safety between the transurethral approach and other approaches substantially eases this long-standing hesitation in urology.

3. Use should not be withheld in oncological patients

The absence of an interaction by cancer status suggests that a similar benefit-risk balance applies in urological oncology patients. That said, standard VTE prophylaxis protocols must never be compromised.

4. An extremely favourable cost-effectiveness profile

TXA is a generic, cheap and widely available agent. The reduction achieved in the need for transfusion means a direct gain both in patient safety and in resource use.

5. Guideline updates should be expected

These data are likely to lay the groundwork for the first formal recommendations on TXA in the EAU and AUA perioperative care guidelines.

Methodological note: This analysis is a prespecified subgroup assessment of the POISE-3 trial. The sample size was not separately calculated for urological endpoints, and the small number of thrombosis events limits the precision of the safety estimates. The findings should be assessed on an individualised basis in the light of procedure type, the patient's baseline bleeding and thrombosis risks, patient preferences and institutional perioperative protocols.

Conclusion

The POISE-3 urological analysis fills the evidence gap on perioperative tranexamic acid use in urological surgery and delivers a threefold message: effective, safe and cheap. The 37% relative reduction achieved in major bleeding is a clinically meaningful gain, and it was achieved without a corresponding increase in thromboembolic events that matter to patients.

In robotic and minimally invasive urological surgery, bleeding control requires a holistic perioperative strategy beyond surgical technique. In the light of these data, the inclusion of tranexamic acid in our perioperative protocols for patients at high bleeding risk should be seriously considered.

References

• Tikkinen KAO, Marcucci M, Halme ALE, et al. Safety and Efficacy of Tranexamic Acid in Urologic Surgery: Results from the International, Randomized, Placebo-Controlled POISE-3 Trial. Eur Urol. 2026;90(2):140-149. doi:10.1016/j.eururo.2026.03.019
• Urology Times. Kari Tikkinen, MD, PhD, discusses POISE-3 findings on tranexamic acid in urologic surgery. 21 August 2026.
• UroToday. Tranexamic Acid in Urologic Surgery and the POISE-3 Subgroup Analysis - AUA 2026.
• Renal & Urology News. Tranexamic Acid Reduces Major Bleeding Risk in Urologic Surgery. 2026.
• Devereaux PJ, Marcucci M, Painter TW, et al. Tranexamic Acid in Patients Undergoing Noncardiac Surgery (POISE-3 main trial). N Engl J Med. 2022;386(21):1986-1997.