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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00862160
Study type Interventional
Source Hannover Medical School
Contact Ingo Kutschka, PD Dr. med.
Phone 0049-511-532-2154
Email kutschka.ingo@mh-hannover.de
Status Recruiting
Phase Phase 4
Start date April 2009
Completion date October 2010

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