Clinical trial NCT00862160: Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit
Official title: Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Acute Cerebrovascular Accident
Intracranial Embolism
Embolism, Air
Keywords: 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
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Academic Teaching Hospital Braunschweig
name: Terumo Europe N.V.
First posted: 2009-03-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: fresh micro-lesions in cranial MRT
timeFrame: before and 72 h after CABG
Secondary outcomes:
measure: Death
timeFrame: 30 days after CABG
measure: Neurological events
timeFrame: between CABG and discharge
measure: Neurocognitive function
timeFrame: before and 3-4 days after CABG and after 3 months
Other outcomes:
Locations:
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig, Department of Cardiothoracic Surgery
city: Hannover
country: Germany
facility: Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Study officials:
affiliation: Hannover Medical School
name: Ingo Kutschka, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: