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

Overview

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 Title of Study: “Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 2010

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.

Interventions

  • Device: ROCsafeTM
    • using minimized perfusion circuit while CABG

Arms, Groups and Cohorts

  • Active Comparator: 1
    • using minimized cardiopulmonary bypass circuit ROCsafeTM
  • No Intervention: 2
    • using standard cardiopulmonary bypass circuit

Clinical Trial Outcome Measures

Primary Measures

  • fresh micro-lesions in cranial MRT
    • Time Frame: before and 72 h after CABG

Secondary Measures

  • Death
    • Time Frame: 30 days after CABG
  • Neurological events
    • Time Frame: between CABG and discharge
  • Neurocognitive function
    • Time Frame: before and 3-4 days after CABG and after 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hannover Medical School
  • Collaborator
    • Academic Teaching Hospital Braunschweig
  • Provider of Information About this Clinical Study
    • PD Dr. med. Ingo Kutschka, HannoverMS, Clinic of Cardiac Thoracic Transplantation and Vascular Surgery
  • Overall Official(s)
    • Ingo Kutschka, PD Dr. med., Principal Investigator, Hannover Medical School
  • Overall Contact(s)
    • Ingo Kutschka, PD Dr. med., 0049-511-532-2154, kutschka.ingo@mh-hannover.de

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