About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Minimal Invasive Extracorporeal Circulation
  • Conventional cardiopulmonary bypass

Treatment groups

1,300 Participants
are divided into 2 treatment groups

Locations

13
Canada
Perfusion Services University Health Network, Toronto General HospitalM5G 2C4, Toronto Canada
Germany
Department of Cardiac Surgery06869, Coswig Germany
Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen Göttingen Germany
Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital89081, Ulm Germany

Sponsors and collaborators

Aristotle University Of Thessaloniki

Lead sponsor

Minimal Invasive Extracorporeal Technologies International Society (MiECTiS)

Collaborator