Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- fresh micro-lesions in cranial MRT
研究概览
简要总结
The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.
详细描述
Coronary artery bypass grafting with extracorporal circulation is established as the golden standard. The conventional cardiopulmonary bypass (CPB) system is associated with inflammatory reaction, hemolysis, hemodilution an disturbances of the blood coagulation system. Also it's well known that neurological disturbances caused by embolic material and air bubbles are potential risks of CPB. The new minimized perfusion circuit ROCsafeTM is a closed, reservoir-less, reduced prime, surface coated circuit, with optimized safety features in effectively eliminate both macro and micro air bubbles and should optimize the clinical outcome after CABG using 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
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is older than 17 years
- •Patient is acceptable candidate for CABG operation
- •Patient or the patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
排除标准
- •Ejection fraction less than 30 %
- •Valve surgery
- •Acute endocarditis or history of endocarditis
- •Cerebral ischemia within 4 weeks before surgery
- •Detection of intracardial thrombi in preoperative echocardiography
- •Stenosis of A. carotis int. greater than 70 %
- •Patients older than 80 years
- •Patients on dialysis
- •Acute myocardial ischemia or infarction within two weeks before inclusion
- •Markedly elevated baseline C-reactive protein (CRP) or leucocytosis
- •Cancer or immunologic diseases
- •Dysregulation of the coagulation cascade (not concerning INR or PTT under cumarin or heparin treatment)
- •Intake of steroids or NSAR
- •Female of childbearing potential
- •Participation in an other study
- •Contraindication for MRI (e.g. pacemaker, any kind of implanted metal)
- •Claustrophobia
结局指标
主要结局
fresh micro-lesions in cranial MRT
时间窗: before and 72 h after CABG
次要结局
- Neurological events(between CABG and discharge)
- Neurocognitive function(before and 3-4 days after CABG and after 3 months)
- Death(30 days after CABG)