Minimally Invasive Extracorporeal Circulation Versus Conventional Heart-Lung Machine Use in Adults Undergoing Cardiac Surgery A Randomised Controlled Trial

What this Trial Is About

Researchers are evaluating the effectiveness of minimally invasive extracorporeal circulation MiECC compared to conventional cardiopulmonary bypass cCPB in reducing serious complications after cardiac surgery. This large multicenter randomized controlled trial, led by the Aristotle University of Thessaloniki, focuses on patients undergoing coronary artery bypass grafting, aortic valve replacement, or both, aiming to see if MiECC can lower the rate of serious postoperative problems such as death, heart attack, stroke, kidney injury, and respiratory complications within 30 days after surgery. Participants are assigned to receive cardiac surgery using either a MiECC system or a conventional heart-lung machine cCPB. The study includes patients undergoing elective or urgent surgery without circulatory arrest and excludes those needing emergency operations or major aortic surgery. The trial will recruit about 1,300 participants across 10 to 15 centers worldwide to detect meaningful differences in postoperative outcomes. During the study, participants will be monitored for serious adverse events up to 30 days after surgery. Researchers will also track blood transfusions, time spent in the cardiac intensive care unit and hospital, new onset postoperative atrial fibrillation, delirium, and health-related quality of life up to 90 days after surgery. Safety and recovery will be carefully assessed through hospital records and clinical evaluations throughout the initial hospital stay and follow-up periods.

MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)