Effect of Remote Ischemic Conditioning on Platelet Dysfunction Following Off-pump Coronary Artery Bypass Surgery
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
- Change of Multiplate ADPtest AUC
研究概览
简要总结
The purpose of this study is to evaluate the effects of remote ischemic conditioning on platelet function during off-pump coronary artery bypass surgery.
详细描述
Remote ischemic conditioning (RIC) may affect platelet function. However, little is known about effect of RIC on platelet function during off-pump coronary artery bypass surgery. In this study investigators are going to perform RIC after anesthesia induction (remote ischemic pre-conditioning) and after completion of coronary anastomoses (remote ischemic post-conditioning), and compare platelet function parameters with control group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 - 80 years of adult patient undergoing elective off-pump coronary artery bypass surgery
排除标准
- •Acute Myocardial Infarction
- •Recent (<1 month) coronary angioplasty (percutaneous coronary intervention, PCI)
- •Acute cerebrovascular ischemia (<6 months)
- •Preoperative LV EF < 30%, mechanical ventricular support (IABP, VAD, ECMO)
- •Peripheral vascular disease
- •Poorly controlled diabetes mellitus
- •Alzheimer's disease
- •NSAIDs within 3 days
- •iv heparin within 6 h
- •low molecular weight heparin within 24 h
- •platelet inhibitor within 24 h
- •known thrombocytopenia
- •renal failure / hemodialysis
- •active infection
- •preoperative bleeding diathesis
- •redo-operation
- •pregnancy
研究组 & 干预措施
Remote ischemic conditioning
Applying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times) before and after coronary anastomoses.
干预措施: Remote ischemic conditioning (Procedure)
Control
All the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
干预措施: Control (Procedure)
结局指标
主要结局
Change of Multiplate ADPtest AUC
时间窗: Baseline, at the end of surgery, postoperative day 1
Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate
次要结局
- Change of Multiplate ASPItest AUC(Baseline, at the end of surgery, postoperative day 1)
- Change of Multiplate COLtest AUC(Baseline, at the end of surgery, postoperative day 1)
- Change of Rotational thromboelastometry EXTEM parameter(Baseline, at the end of surgery, postoperative day 1)
- Change of Rotational thromboelastometry FIBTEM parameter(Baseline, at the end of surgery, postoperative day 1)
- Rotational thromboelastometry INTEM parameter(Baseline, at the end of surgery, postoperative day 1)
- Change of Rotational thromboelastometry HEPTEM parameter(Baseline, at the end of surgery, postoperative day 1)
- Amount of peri-operative bleeding and transfusion(At the end of surgery, postoperative day 1,2,3)
研究者
Yunseok Jeon
Professor
Seoul National University Hospital