MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial
Aristotle University Of Thessaloniki
1,300 participants
May 26, 2022
INTERVENTIONAL
Conditions
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 Criteria1
- 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 Criteria5
- 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).
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Interventions
Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).
Cardiac surgery with conventional cardiopulmonary bypass (cCPB).
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05487612