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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 surgeryстатья
- Авторы: Marcucc Maura, Painter Thomas W., Conen David, Likhvantsev Valery, Kuzovlev Artem, Kadantseva Kristina, Subbotin Valerii, Berikashvili Levan, Devereaux P.J.
- Журнал: Trials
- Том: 23
- Номер: 101
- Год издания: 2022
- Издательство: BioMed Central
- Местоположение издательства: London
- DOI: 10.1186/s13063-021-05992-1
- Аннотация: Methods: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization.Discussion: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality.Trial registration: ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.Keywords: Noncardiac surgery, Tranexamic acid, Perioperative bleeding, Perioperative hypotension, Cardiovascularcomplications, Randomized controlled trial
- Добавил в систему: Каданцева Кристина Кирилловна