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

Hannover Medical School (MHH)

Status and phase: Unknown; Phase 4

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

Treatments: Device: ROCsafeTM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00862160

T201E1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

1

Active Comparator group

Description:

using minimized cardiopulmonary bypass circuit ROCsafeTM

Treatment:

Device: ROCsafeTM

2

No Intervention group

Description:

using standard cardiopulmonary bypass circuit