MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Recruiting
CT.gov ID
NCT05487612
Collaborator
Clinical Research Unit, School of Medicine, Aristotle University of Thessaloniki (Other)
1,300
13
2
46.2
100
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Minimal Invasive Extracorporeal Circulation
  • Device: Conventional cardiopulmonary bypass
N/A

Detailed Description

Despite a fall in mortality rates over the past decade, patients having cardiac surgery continue to experience serious postoperative complications. The risk of serious and relatively common surgical complications is often a consequence of stopping the heart during the operation, using the heart and lung machine (conventional cardiopulmonary bypass; cCPB), and restarting and reperfusing the heart at the end of the operation. Although several strategies have been developed to reduce such complications, they still occur and can be life threatening; they also increase the length of time a patient spends in the hospital.

Miniaturised heart lung machines (minimally invasive extracorporeal circulation; MiECC) have been developed with the aim of reducing the number of postoperative complications arising from using cCPB. Because of the variety of miniaturised systems that have been evaluated, the different types of patients and outcomes investigated, and the poor quality of previous studies, the effectiveness of MiECC in reducing postoperative complications has not been established and most hospitals continue to use cCPB.

Our primary hypothesis is that, compared to cCPB, using a MiECC system during cardiac surgery reduces the proportion of patients having one of several serious postoperative complications (death, myocardial infarction, stroke, acute kidney injury, reintubation, tracheostomy, mechanical ventilation for more than 48 hours, or reoperation) up to 30 days after surgery. In addition, the investigators hypothesise that MiECC reduces the amount of blood products transfused, time to discharge from the cardiac intensive care unit and hospital and the health care resources used during the hospital stay.

Study investigators propose to carry out a large, multicentre randomised controlled trial in 10 to 15 cardiac surgery centres worldwide. Patients will be eligible if they are having coronary artery bypass surgery, aortic valve replace or both using a heart lung machine without circulatory arrest. Centres may recruit patients having all, or a subset of, operation types.

It is expected that 20 % to 23% of patients will experience one or more of the serious complications (the primary outcome). In order to be able confidently to detect a 30% relative reduction in the risk of this outcome, the investigators plan to recruit 1,300 participants across all sites.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or both procedures CABG+AVR using extracorporeal circulation without circulatory arrest will be randomised (1:1 ratio) to having surgery using Minimal Invasive Extracorporeal Circulation (MiECC) or conventional cardiopulmonary bypass (cCPB).Patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or both procedures CABG+AVR using extracorporeal circulation without circulatory arrest will be randomised (1:1 ratio) to having surgery using Minimal Invasive Extracorporeal Circulation (MiECC) or conventional cardiopulmonary bypass (cCPB).
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial
Actual Study Start Date :
May 26, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Minimal Invasive Extracorporeal Circulation (MiECC)

Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with Minimal Invasive Extracorporeal Circulation (MiECC).

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

Active Comparator: Conventional Cardiopulmonary Bypass (cCPB)

Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with conventional cardiopulmonary bypass (cCPB)

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Secondary Outcome Measures

  1. All-cause mortality [30 days after randomization following the index admission]

    All-cause mortality

  2. New-onset postoperative atrial fibrillation [Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.]

    Incidence of new-onset postoperative atrial fibrillation

  3. Rate of red blood cells transfusion [30 days after randomization following the index admission]

    Units of red blood cells transfused

  4. Rate of platelet transfusion [30 days after randomization following the index admission]

    Units of platelets transfused

  5. Rate of fresh frozen plasma transfusion [30 days after randomization following the index admission]

    Units of fresh frozen plasma transfused

  6. Rate of cryoprecipitate transfusion [30 days after randomization following the index admission]

    Units of cryoprecipitate transfused

  7. Activated Factor VII administration [30 days after randomization following the index admission]

    Incidence of activated factor VII administration

  8. Fibrinogen administration [30 days after randomization following the index admission]

    Incidence of fibrinogen administration

  9. Prothrombin complex concentrate administration [30 days after randomization following the index admission]

    Incidence of prothrombin complex concentrate administration

  10. Time to discharge from cardiac ICU [Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.]

    Time to discharge from cardiac ICU

  11. Time to discharge from hospital [Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.]

    Time to discharge from hospital

  12. Delirium [Up to 5 days postoperatively]

    Incidence of postoperative delirium

  13. Health-Related Quality of Life (HRQoL) [90 days after randomization]

    HRQoL assessed with EQ-5D questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Perfusion Services University Health Network, Toronto General Hospital Toronto Canada M5G 2C4
2 Department of Cardiothoracic and Vascular Surgery Braunschweig Germany 38126
3 Department of Cardiac Surgery Coswig Germany 06869
4 Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen Göttingen Germany
5 Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital Ulm Germany 89081
6 Cardiothoracic Department AHEPA University Hospital ThessalonĂ­ki Greece 54636
7 Department of Cardiac Surgery GVM Anthea Hospital Bari Italy 70124
8 Department of Cardiac Surgery GVM Maria Eleonora Hospital Palermo Italy 90135
9 Department of Cardiovascular Surgery, University Hospital Bern Bern Switzerland CH-3010
10 Department of Cardiovascular Surgery, Ankara City Hospital Ankara Turkey
11 Department of Cardiac Surgery, Royal Papworth Hospital Cambridge United Kingdom CB2 0AY
12 Deparment of Cardiac Surgery, Castle Hill Hospital Hull United Kingdom HU16 5JQ
13 Department of Cardiothoracic Surgery, Hammersmith Hospital London United Kingdom W120HS

Sponsors and Collaborators

  • Aristotle University Of Thessaloniki
  • Clinical Research Unit, School of Medicine, Aristotle University of Thessaloniki

Investigators

  • Study Chair: Kyriakos Anastasiadis, Professor, Aristotle University Of Thessaloniki, School of Medicine
  • Study Director: Polychronis Antonitsis, Assoc. Prof., Aristotle University Of Thessaloniki, School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT05487612
Other Study ID Numbers:
  • MiECS
First Posted:
Aug 4, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aristotle University Of Thessaloniki
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022