Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass

Conditions
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Coronary Artery Disease, Acute Cerebrovascular Accident, Intracranial Embolism, Embolism, Air

Intervention / Treatment
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* Device: ROCsafeTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>using minimized cardiopulmonary bypass circuit ROCsafeTM | Device: ROCsafeTM<br>* using minimized perfusion circuit while CABG<br>|
| No Intervention: 2<br>using standard cardiopulmonary bypass circuit | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fresh micro-lesions in cranial MRT |  | before and 72 h after CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 30 days after CABG | 
| Neurological events |  | between CABG and discharge | 
| Neurocognitive function |  | before and 3-4 days after CABG and after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery bypass surgery, cardiopulmonary bypass, heart lung machine, acute cerebrovascular event, intracranial embolism, embolism, air, outcome assessment (health care), neuropsychological tests, magnetic resonance imaging, saccadic eye movement test