Effect of Remote Ischemic Preconditioning on Platelet Activation During Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Platelet activation measured by CD62P expression using flow cytometry
研究概览
简要总结
In this study, the investigators are going to investigate the effects of remote ischemic preconditioning on platelet activation in patients undergoing cardiac surgery with cardiopulmonary bypass.
详细描述
Previous studies reported that remote ischemic conditioning reduce platelet activation in patients with coronary artery disease or patients undergoing ablation for atrial fibrillation. Cardiac surgery with cardiopulmonary bypass has been associated with platelet activation. In this randomized study, investigators are going to compare the effects of remote ischemic preconditioning (RIPC) on platelet activation using flow cytometry in patients undergoing cardiac surgery with cardiopulmonary bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cardiac surgery with cardiopulmonary bypass
排除标准
- •Preoperative left ventricle ejection fraction < 30%, mechanical ventricular support
- •Peripheral vascular disease
- •Poorly controlled diabetes mellitus
- •NSAIDs within 3 days
- •iv heparin within 6 h
- •low molecular weight heparin within 24 h
- •platelet inhibitor within 24 h
- •known thrombocytopenia
- •End stage renal disease / hemodialysis
- •Active infection
- •Pregnancy
研究组 & 干预措施
Remote ischemic preconditioning
Remote ischemic conditioning after anesthesia induction
- four cycles of 5 min of ischemia followed by 5 min of reperfusion by inflation to 200 mm Hg and deflation of a blood pressure cuff on the upper arm
干预措施: Remote ischemic preconditioning (Device)
Sham control
The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10mm Hg.
干预措施: Sham control (Device)
结局指标
主要结局
Platelet activation measured by CD62P expression using flow cytometry
时间窗: During 3hour after cardiopulmonary bypass initiation
CD62P AUC (area under the curve)
次要结局
- ASPItest by Multiplate® platelet function analyser(3hour after cardiopulmonary bypass initiation)
- Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry(During 3hour after cardiopulmonary bypass initiation)
- ADPtest by Multiplate® platelet function analyser(3hour after cardiopulmonary bypass initiation)
- COLtest by Multiplate® platelet function analyser(3hour after cardiopulmonary bypass initiation)
- Platelet activation measured by CD63 expression using flow cytometry(During 3hour after cardiopulmonary bypass initiation)
- Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry(During 3hour after cardiopulmonary bypass initiation)
- Platelet activation measured by PAC1 expression using flow cytometry(During 3hour after cardiopulmonary bypass initiation)
研究者
Yunseok Jeon
Professor
Seoul National University Hospital