NCT03505723: POISE-3

PeriOperative ISchemic Evaluation-3 Trial

Completed Phase 3 Last updated 12 February 2025

What this trial tests

Phase 3 trial testing Tranexamic Acid in Perioperative Bleeding in 9,535 participants. Completed in 3 February 2023.

Timeline

27 June 2018

Primary endpoint
8 November 2021

3 February 2023

Quick facts

Lead sponsor	Population Health Research Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Enrollment	9,535
Start date	27 June 2018
Primary completion	8 November 2021
Estimated completion	3 February 2023
Sites	114 locations across Hong Kong, Italy, Malaysia, Poland, Denmark, New Zealand, Netherlands, Russia

Drugs / interventions tested

• Tranexamic Acid (Tranexamic Acid) — full drug profile →
• Placebo (Saline)
• Perioperative hypotension-avoidance strategy
• Perioperative hypertension-avoidance strategy

Conditions studied

• Perioperative Bleeding — all drugs for Perioperative Bleeding →
• Venous Thrombosis — all drugs for Venous Thrombosis →
• Arterial Thrombosis — all drugs for Arterial Thrombosis →

Sponsor

Population Health Research Institute

Who can join

45 and older, any sex, with Perioperative Bleeding or Venous Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tranexamic Acid in Patients Undergoing Noncardiac Surgery.
   Devereaux PJ, Marcucci M, Painter TW, Conen D, et al · · 2022 · cited 229× · PMID 35363452 · DOI 10.1056/nejmoa2201171
2. Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial.
   Marcucci M, Painter TW, Conen D, Lomivorotov V, et al · · 2023 · cited 121× · PMID 37094336 · DOI 10.7326/m22-3157
3. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery.
   Marcucci M, Painter TW, Conen D, Leslie K, et al · · 2022 · cited 15× · PMID 35101083 · DOI 10.1186/s13063-021-05992-1
4. Drugs to reduce bleeding and transfusion in major open vascular or endovascular surgery: a systematic review and network meta-analysis.
   Beverly A, Ong G, Kimber C, Sandercock J, et al · · 2023 · cited 12× · PMID 36800489 · DOI 10.1002/14651858.cd013649.pub2
5. Safety and Efficacy of Tranexamic Acid in General Surgery.
   Park LJ, Marcucci M, Ofori SN, Borges FK, et al · · 2025 · cited 9× · PMID 39813061 · DOI 10.1001/jamasurg.2024.6048
6. A sub-study of the POISE-3 randomized trial examined effects of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury.
   POISE-3 Trial Investigators and Study Groups. · · 2025 · cited 9× · PMID 39490985 · DOI 10.1016/j.kint.2024.10.007
7. Perioperative myocardial injury and infarction after noncardiac surgery: a review of pathophysiology, diagnosis, and management.
   Kashlan B, Kinno M, Syed M. · · 2024 · cited 6× · PMID 38343871 · DOI 10.3389/fcvm.2024.1323425
8. Effects of a Hypotension-Avoidance Versus a Hypertension-Avoidance Strategy on Neurocognitive Outcomes After Noncardiac Surgery.
   Marcucci M, Chan MTV, Painter TW, Efremov S, et al · · 2025 · cited 4× · PMID 40456161 · DOI 10.7326/annals-24-02841