MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
NCT05487612
Summary
MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.
Eligibility
Inclusion Criteria: * All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest. Exclusion Criteria: * Requirement for emergency or salvage operation. * Requirement for major aortic surgery (e.g. aortic root replacement). * Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products. * Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded). * Inability to give informed consent for the study (e.g. learning or language difficulties).
Conditions4
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NCT05487612