MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAristotle University Of Thessaloniki
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Minimal Invasive Extracorporeal Circulation
DeviceCardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).
Conventional cardiopulmonary bypass
DeviceCardiac surgery with conventional cardiopulmonary bypass (cCPB).
Treatment groups
1,300 Participants
are divided into 2 treatment groupsGroup A: Minimal Invasive Extracorporeal Circulation (MiECC)Active comparator 1 intervention
Group B: Conventional Cardiopulmonary Bypass (cCPB)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite outcome of postoperative serious adverse events
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.
Time frame
30 days after randomization following the index admissionSecondary outcomes
1
All-cause mortality
All-cause mortality
Time frame
30 days after randomization following the index admission2
New-onset postoperative atrial fibrillation
Incidence of new-onset postoperative atrial fibrillation
Time frame
Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.3
Rate of red blood cells transfusion
Units of red blood cells transfused
Time frame
30 days after randomization following the index admission4
Rate of platelet transfusion
Units of platelets transfused
Time frame
30 days after randomization following the index admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aristotle University Of Thessaloniki
Lead sponsor
Minimal Invasive Extracorporeal Technologies International Society (MiECTiS)
Collaborator
Source ClinicalTrials.gov