RecruitingNot ApplicableNCT05487612

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


Sponsor

Aristotle University Of Thessaloniki

Enrollment

1,300 participants

Start Date

May 26, 2022

Study Type

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

Min Age: 18 YearsMax Age: 85 Years

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

DEVICEMinimal Invasive Extracorporeal Circulation

Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).

DEVICEConventional cardiopulmonary bypass

Cardiac surgery with conventional cardiopulmonary bypass (cCPB).


Locations(13)

Perfusion Services University Health Network, Toronto General Hospital

Toronto, Canada

Department of Cardiac Surgery

Coswig, Germany

Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen

Göttingen, Germany

Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital

Ulm, Germany

Cardiothoracic Department AHEPA University Hospital

Thessaloniki, Greece

Department of Cardiac Surgery GVM Anthea Hospital

Bari, Italy

Department of Cardiac Surgery GVM Maria Eleonora Hospital

Palermo, Italy

Department of Cardiovascular Surgery, Ankara City Hospital

Ankara, Turkey (Türkiye)

Department of Cardiovascular Surgery, Izmir Bakırçay University, Faculty of Medicine

Izmir, Turkey (Türkiye)

Department of Cardiovascular Surgery, Faculty of Medicine, Recep Tayyip Erdoğan University

Rize, Turkey (Türkiye)

Department of Cardiac Surgery, Royal Papworth Hospital

Cambridge, United Kingdom

Deparment of Cardiac Surgery, Castle Hill Hospital

Hull, United Kingdom

Department of Cardiothoracic Surgery, Hammersmith Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05487612


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