Department of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Department of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Trials. 2022 Jan 31;23(1):101. doi: 10.1186/s13063-021-05992-1.
For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes.
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.
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.
ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.
对于接受非心脏手术的患者，出血和低血压较为常见，且与死亡率和心血管并发症的增加相关。氨甲环酸（TXA）是一种抗纤维蛋白溶解剂，具有减少手术出血的潜力；然而，其在非心脏手术中的疗效和安全性尚不确定。尽管通常的围手术期护理符合高血压回避策略（即大多数患者在围手术期内继续使用降压药物，术中平均动脉压 60mmHg 通常被接受），但低血压回避策略可能会改善围手术期结局。
围手术期缺血评估（POISE-3）试验是一项大型国际随机对照试验，旨在确定 TXA 是否优于安慰剂，用于 30 天后危及生命、主要和重要器官出血的复合结局，以及是否不劣于安慰剂，用于主要动脉和静脉血栓栓塞事件的发生，在随机分组后 30 天。使用部分析因设计，POISE-3 还将确定低血压回避策略与高血压回避策略对 30 天后主要心血管事件风险的影响。目标样本量为 10000 名参与者。年龄≥45 岁、有或有心血管和出血并发症风险的非心脏手术患者，随机接受 TXA1g 静脉推注或手术开始和结束时匹配的安慰剂。患者、医护人员、数据收集者、结局裁决者和研究者对治疗分配均设盲。接受≥1 种慢性降压药物治疗的患者还随机分为两种血压管理策略，两种策略在手术当天早上和手术后前两天患者降压药物的管理以及手术期间的目标平均动脉压方面存在差异。结局裁决者对血压治疗分配设盲。患者在随机分组后 30 天和 1 年进行随访。
非心脏手术中的出血和低血压较为常见，对患者预后有重大影响。POISE-3 试验将评估两种干预措施，以确定它们对出血、心血管并发症和死亡率的影响。
ClinicalTrials.gov NCT03505723。于 2018 年 4 月 23 日注册。
