MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)

NCT05487612 · tracked via the Priya Life Science Germany tracker

Sponsor

Aristotle University Of Thessaloniki

Phase

Not applicable

Started

2022-05-26

Last updated

2026-03-30

Condition(s) studied

Coronary Artery DiseaseAortic Valve StenosisExtracorporeal Circulation; Complications

Investigational drug(s) / intervention(s)

Minimal Invasive Extracorporeal CirculationConventional cardiopulmonary bypass

Minimal Invasive Extracorporeal Circulation: Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).

Conventional cardiopulmonary bypass: Cardiac surgery with conventional cardiopulmonary bypass (cCPB).

Study 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

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

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).

Primary outcome measure(s)

Composite outcome of postoperative serious adverse events — 30 days after randomization following the index admission
Incidence of: death, postoperative myocardial infarction according to Fourth Universal Definition of myocardial infarction, stroke, all stage acute kidney injury, as defined with AKI Network criteria, Re-intubation, need for mechanical ventilation for \> 48 hours, including multiple episodes when separated by more than 12 hours, reoperation and septicaemia confirmed by positive blood culture.

Trial sites (13)

Facility	City	Region	Status
Perfusion Services University Health Network, Toronto General Hospital	Toronto	Canada	Recruiting
Department of Cardiac Surgery	Coswig	Germany	Active Not Recruiting
Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen	Göttingen	Germany	Active Not Recruiting
Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital	Ulm	Germany	Completed
Cardiothoracic Department AHEPA University Hospital	Thessaloniki	Greece	Recruiting
Department of Cardiac Surgery GVM Anthea Hospital	Bari	Italy	Recruiting
Department of Cardiac Surgery GVM Maria Eleonora Hospital	Palermo	Italy	Active Not Recruiting
Department of Cardiovascular Surgery, Ankara City Hospital	Ankara	Turkey (Türkiye)	Active Not Recruiting
Department of Cardiovascular Surgery, Izmir Bakırçay University, Faculty of Medicine	Izmir	Turkey (Türkiye)	Recruiting
Department of Cardiovascular Surgery, Faculty of Medicine, Recep Tayyip Erdoğan University	Rize	Turkey (Türkiye)	Recruiting
Department of Cardiac Surgery, Royal Papworth Hospital	Cambridge	United Kingdom	Active Not Recruiting
Deparment of Cardiac Surgery, Castle Hill Hospital	Hull	United Kingdom	Active Not Recruiting
Department of Cardiothoracic Surgery, Hammersmith Hospital	London	United Kingdom	Active Not Recruiting

Other trials for the same condition

accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis Active, not recruiting

Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial Active, not recruiting

The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial Active, not recruiting

Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis Recruiting

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05487612 on ClinicalTrials.gov ↗ ← All trials in Germany