Comparing minimal invasive extracorporeal circulation to conventional cardiopulmonary bypass in heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Perfusion Services University Health Network, Toronto General Hospital
  Toronto, Canada Recruiting
• Cardiothoracic Department AHEPA University Hospital
  Thessaloniki, Greece Recruiting
• Department of Cardiac Surgery GVM Anthea Hospital
  Bari, Italy 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
  Coswig, Germany Active not recruiting

Study contacts

• Study coordinator: Georgios Papazisis, Assoc. Prof.
• Email: papazisg@auth.gr
• Phone: +30 2310999323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.