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

August 4, 2022 updated by: Aristotle University Of Thessaloniki

Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • Canada
      • Toronto, Canada, M5G 2C4
        • Active, not recruiting
        • Perfusion Services University Health Network, Toronto General Hospital
  • Germany
      • Braunschweig, Germany, 38126
        • Active, not recruiting
        • Department of Cardiothoracic and Vascular Surgery
      • Coswig, Germany, 06869
        • Active, not recruiting
        • Department of Cardiac Surgery
      • Göttingen, Germany
        • Active, not recruiting
        • Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen
      • Ulm, Germany, 89081
        • Active, not recruiting
        • Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital
  • Greece
      • Thessaloníki, Greece, 54636
        • Recruiting
        • Cardiothoracic Department AHEPA University Hospital
  • Italy
      • Bari, Italy, 70124
        • Active, not recruiting
        • Department of Cardiac Surgery GVM Anthea Hospital
      • Palermo, Italy, 90135
        • Active, not recruiting
        • Department of Cardiac Surgery GVM Maria Eleonora Hospital
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Active, not recruiting
        • Department of Cardiovascular Surgery, University Hospital Bern
  • Turkey
      • Ankara, Turkey
        • Active, not recruiting
        • Department of Cardiovascular Surgery, Ankara City Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0AY
        • Active, not recruiting
        • Department of Cardiac Surgery, Royal Papworth Hospital
      • Hull, United Kingdom, HU16 5JQ
        • Active, not recruiting
        • Deparment of Cardiac Surgery, Castle Hill Hospital
      • London, United Kingdom, W120HS
        • Active, not recruiting
        • Department of Cardiothoracic Surgery, Hammersmith Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome of postoperative serious adverse events
Time Frame: 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.
30 days after randomization following the index admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 30 days after randomization following the index admission
All-cause mortality
30 days after randomization following the index admission
New-onset postoperative atrial fibrillation
Time Frame: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Incidence of new-onset postoperative atrial fibrillation
Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Rate of red blood cells transfusion
Time Frame: 30 days after randomization following the index admission
Units of red blood cells transfused
30 days after randomization following the index admission
Rate of platelet transfusion
Time Frame: 30 days after randomization following the index admission
Units of platelets transfused
30 days after randomization following the index admission
Rate of fresh frozen plasma transfusion
Time Frame: 30 days after randomization following the index admission
Units of fresh frozen plasma transfused
30 days after randomization following the index admission
Rate of cryoprecipitate transfusion
Time Frame: 30 days after randomization following the index admission
Units of cryoprecipitate transfused
30 days after randomization following the index admission
Activated Factor VII administration
Time Frame: 30 days after randomization following the index admission
Incidence of activated factor VII administration
30 days after randomization following the index admission
Fibrinogen administration
Time Frame: 30 days after randomization following the index admission
Incidence of fibrinogen administration
30 days after randomization following the index admission
Prothrombin complex concentrate administration
Time Frame: 30 days after randomization following the index admission
Incidence of prothrombin complex concentrate administration
30 days after randomization following the index admission
Time to discharge from cardiac ICU
Time Frame: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
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 hospital
Time Frame: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Time to discharge from hospital
Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Delirium
Time Frame: Up to 5 days postoperatively
Incidence of postoperative delirium
Up to 5 days postoperatively
Health-Related Quality of Life (HRQoL)
Time Frame: 90 days after randomization
HRQoL assessed with EQ-5D questionnaire
90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MiECS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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