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.
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.
- ROCsafeTM Device
Intervention Desc: using minimized perfusion circuit while CABG ARM 1: Kind: Experimental Label: 1 Description: using minimized cardiopulmonary bypass circuit ROCsafeTM
- Allocation: Randomized
- Masking: Double Blind (Subject, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||fresh micro-lesions in cranial MRT||before and 72 h after CABG||Yes|
|Secondary||Death||30 days after CABG||Yes|
|Secondary||Neurological events||between CABG and discharge||Yes|
|Secondary||Neurocognitive function||before and 3-4 days after CABG and after 3 months||Yes|