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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Hannover Medical School

Current Primary Outcome: fresh micro-lesions in cranial MRT [ Time Frame: before and 72 h after CABG ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Hannover Medical School

Dates:
Date Received: March 13, 2009
Date Started: April 2009
Date Completion: October 2010
Last Updated: October 6, 2009
Last Verified: October 2009