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

Phase 4

• Conditions: Coronary Artery Disease; Acute Cerebrovascular Accident; Intracranial Embolism; Embolism, Air
• Interventions: Device: ROCsafeTM

• Registration Number: NCT00862160
• Lead Sponsor: Hannover Medical School

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Study Start: 2009-04
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-06
• Last Update Posted: 2009-10-07
• Primary Completion: 2010-04
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ROCsafeTM	using minimized cardiopulmonary bypass circuit ROCsafeTM

Primary Outcome Measures

Name	Time	Method
fresh micro-lesions in cranial MRT	before and 72 h after CABG

Secondary Outcome Measures

Name	Time	Method
Neurological events	between CABG and discharge
Neurocognitive function	before and 3-4 days after CABG and after 3 months
Death	30 days after CABG

Trial Locations

Locations (2)

Klinikum Braunschweig, Department of Cardiothoracic Surgery; 🇩🇪 Braunschweig, Germany

Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery; 🇩🇪 Hannover, Germany