PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study (POISE-3)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in hemoglobin
研究概览
简要总结
A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.
详细描述
The POISE-3 pilot is a randomized controlled trial of 100 patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Utilizing a partial factorial design, the POISE-3 pilot will determine the effect of rosuvastatin versus placebo and TXA versus placebo in the perioperative setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing noncardiac surgery
- •>45 years of age
- •expected to require at least an overnight hospital admission after surgery; AND
- •have a preoperative NT-pro-BNP measurement >100 ng/mL; OR
- •if a preoperative NT-pro-BNP measurement is not available, then the patient must fulfill 1 or more of the following 5 criteria:
- •history of coronary artery disease
- •history of peripheral vascular disease
- •history of stroke
- •undergoing major vascular surgery
- •have any 3 of the following 9 risk criteria:
- •undergoing major surgery
- •history of congestive heart failure
- •history of a transient ischemic attack
- •diabetic and currently taking an oral hypoglycemic agent or insulin
- •age >70 years
- •hypertension
- •serum creatinine > 175 umol/L (>2.0 mg/dl)
- •history of smoking within 2 years of surgery
- •undergoing emergent/urgent surgery
排除标准
- •planned use of systemic Tranexamic Acid during surgery
- •hypersensitivity or known allergy to TXA
- •creatinine clearance <30 mL/min (MDRD)
- •history of seizure disorder
- •history of venous thromboembolism
- •acute arterial thrombosis
- •no preoperative measurement of hemoglobin
- •subarachnoid hemorrhage within the past 30 days
- •hematuria caused by diseases of the renal parenchyma
- •previously enrolled in POISE-3 pilot trial
- •not consenting to participate in POISE-3 pilot trial prior to surgery
- •Patients meeting any of the following criteria will be excluded from the Rosuvastatin/Placebo arm:
- •preoperative treatment with a statin or a non statin lipid lowering drug or ciclosporin during the 48 hours before surgery
- •hypersensitivity or known allergy to Rosuvastatin
- •pre-disposed factors for myopathy or rhabdomyolysis
研究组 & 干预措施
Tranexamic Acid vs. matching placebo
Tranexamic Acid 1g bolus with anesthesia induction followed by 1g bolus at the start of surgical closure.
干预措施: Tranexamic Acid Placebo (Drug)
Tranexamic Acid vs. matching placebo
Tranexamic Acid 1g bolus with anesthesia induction followed by 1g bolus at the start of surgical closure.
干预措施: Tranexamic Acid (Drug)
Rosuvastatin vs. matching placebo
Rosuvastatin 20 mg orally or matching placebo once per day until 30 days after surgery
干预措施: Rosuvastatin or matching placebo (Drug)
结局指标
主要结局
Change in hemoglobin
时间窗: Postoperative day 1.
Change in preoperative hemoglobin to the morning hemoglobin recorded on day 1 after surgery.
Postoperative intervention discontinuation
时间窗: Postoperative day 1 to 30.
Interruption of the intervention longer than 24 hours within the first 10 days postoperatively, and longer than 48 hours from postoperative day 10 to 30.
次要结局
- All-cause mortality(Postoperative day 30.)
- Non-fatal myocardial infarction(Postoperative day 30.)
- A composite of vascular mortality and non-fatal: myocardial infarction, stroke, cardiac arrest, pulmonary embolus, deep venous thrombosis, life threatening bleeding, major bleeding.(Postoperative day 30.)