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Recruiting NCT05487612

NCT05487612 MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)

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Clinical Trial Summary
NCT ID NCT05487612
Status Recruiting
Phase
Sponsor Aristotle University Of Thessaloniki
Condition Coronary Artery Disease
Study Type INTERVENTIONAL
Enrollment 1,300 participants
Start Date 2022-05-26
Primary Completion 2028-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 85 Years
Study Type INTERVENTIONAL
Interventions
Minimal Invasive Extracorporeal CirculationConventional cardiopulmonary bypass

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 1,300 participants in total. It began in 2022-05-26 with a primary completion date of 2028-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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).

Contact & Investigator

Central Contact

Georgios Papazisis, Assoc. Prof.

✉ papazisg@auth.gr

📞 +30 2310999323

Principal Investigator

Kyriakos Anastasiadis, Professor

STUDY CHAIR

Aristotle University Of Thessaloniki

Frequently Asked Questions

Who can join the NCT05487612 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05487612 currently recruiting?

Yes, NCT05487612 is actively recruiting participants. Contact the research team at papazisg@auth.gr for enrollment information.

Where is the NCT05487612 trial being conducted?

This trial is being conducted at Toronto, Canada, Coswig, Germany, Göttingen, Germany, Ulm, Germany and 9 additional locations.

Who is sponsoring the NCT05487612 clinical trial?

NCT05487612 is sponsored by Aristotle University Of Thessaloniki. The principal investigator is Kyriakos Anastasiadis, Professor at Aristotle University Of Thessaloniki. The trial plans to enroll 1,300 participants.

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