Comparing minimal invasive extracorporeal circulation to conventional cardiopulmonary bypass in heart surgery
Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial
NA · Aristotle University Of Thessaloniki · NCT05487612
This study is testing if a new heart surgery method called minimal invasive extracorporeal circulation can help patients avoid serious complications better than the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki (other) |
| Locations | 13 sites (Toronto and 12 other locations) |
| Trial ID | NCT05487612 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of minimal invasive extracorporeal circulation (MiECC) compared to conventional cardiopulmonary bypass (cCPB) in patients undergoing cardiac surgery, specifically coronary artery bypass grafting and aortic valve replacement. It aims to determine if MiECC can reduce serious postoperative complications such as death, myocardial infarction, and acute kidney injury. The trial is multicenter and randomized, involving several hospitals and led by a prominent research unit in Greece. The primary focus is on assessing the incidence of complications within 30 days post-surgery.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for elective or urgent coronary artery bypass grafting or aortic valve replacement who do not have contraindications for blood transfusions.
Not a fit: Patients requiring emergency surgery, major aortic surgery, or those with specific blood disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery outcomes for patients undergoing cardiac surgery.
How similar studies have performed: While previous studies on MiECC have been limited and varied in quality, this trial aims to provide robust evidence on its effectiveness compared to cCPB.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Toronto and 12 other locations
- 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)
Study contacts
- Study coordinator: Georgios Papazisis, Assoc. Prof.
- Email: papazisg@auth.gr
- Phone: +30 2310999323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Aortic Valve Stenosis, Extracorporeal Circulation, Complications, Cardiopulmonary bypass, Extracorporeal circulation, Minimal invasive extracorporeal circulation, Coronary artery bypass grafting