Status:
UNKNOWN
Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Academic Teaching Hospital Braunschweig
Terumo Europe N.V.
Conditions:
Coronary Artery Disease
Acute Cerebrovascular Accident
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 cardiopulm...
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, hem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00862160
Start Date
April 1 2009
End Date
October 1 2010
Last Update
October 7 2009
Active Locations (2)
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1
Klinikum Braunschweig, Department of Cardiothoracic Surgery
Braunschweig, Germany, 38126
2
Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Hanover, Germany, 30625