NCT05487612

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
35mo left

Started May 2022

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
6 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
May 2022Mar 2029

Study Start

First participant enrolled

May 26, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

6.6 years

First QC Date

August 1, 2022

Last Update Submit

March 27, 2026

Conditions

Coronary Artery DiseaseAortic Valve StenosisExtracorporeal Circulation; Complications

Keywords

Cardiopulmonary bypassExtracorporeal circulationMinimal invasive extracorporeal circulationCoronary artery bypass graftingAortic valve replacement

Outcome Measures

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.

    30 days after randomization following the index admission

Secondary Outcomes (13)

  • All-cause mortality

    30 days after randomization following the index admission

  • 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

    30 days after randomization following the index admission

  • Rate of platelet transfusion

    30 days after randomization following the index admission

  • Rate of fresh frozen plasma transfusion

    30 days after randomization following the index admission

  • +8 more secondary outcomes

Study Arms (2)

Minimal Invasive Extracorporeal Circulation (MiECC)

ACTIVE COMPARATOR

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

Conventional Cardiopulmonary Bypass (cCPB)

ACTIVE COMPARATOR

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

Interventions

Conventional cardiopulmonary bypassDEVICE

Cardiac surgery with conventional cardiopulmonary bypass (cCPB).

Conventional Cardiopulmonary Bypass (cCPB)
Minimal Invasive Extracorporeal CirculationDEVICE

Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).

Minimal Invasive Extracorporeal Circulation (MiECC)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Perfusion Services University Health Network, Toronto General Hospital

Toronto, M5G 2C4, Canada

RECRUITING

Department of Cardiac Surgery

Coswig, 06869, Germany

ACTIVE NOT RECRUITING

Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen

Göttingen, Germany

ACTIVE NOT RECRUITING

Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital

Ulm, 89081, Germany

COMPLETED

Cardiothoracic Department AHEPA University Hospital

Thessaloniki, 54636, Greece

RECRUITING

Department of Cardiac Surgery GVM Anthea Hospital

Bari, 70124, Italy

RECRUITING

Department of Cardiac Surgery GVM Maria Eleonora Hospital

Palermo, 90135, Italy

ACTIVE NOT RECRUITING

Department of Cardiovascular Surgery, Ankara City Hospital

Ankara, Turkey (Türkiye)

ACTIVE NOT 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, Royal Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

ACTIVE NOT RECRUITING

Deparment of Cardiac Surgery, Castle Hill Hospital

Hull, HU16 5JQ, United Kingdom

ACTIVE NOT RECRUITING

Department of Cardiothoracic Surgery, Hammersmith Hospital

London, W120HS, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (8)

  • Anastasiadis K, Murkin J, Antonitsis P, Bauer A, Ranucci M, Gygax E, Schaarschmidt J, Fromes Y, Philipp A, Eberle B, Punjabi P, Argiriadou H, Kadner A, Jenni H, Albrecht G, van Boven W, Liebold A, de Somer F, Hausmann H, Deliopoulos A, El-Essawi A, Mazzei V, Biancari F, Fernandez A, Weerwind P, Puehler T, Serrick C, Waanders F, Gunaydin S, Ohri S, Gummert J, Angelini G, Falk V, Carrel T. Use of minimal invasive extracorporeal circulation in cardiac surgery: principles, definitions and potential benefits. A position paper from the Minimal invasive Extra-Corporeal Technologies international Society (MiECTiS). Interact Cardiovasc Thorac Surg. 2016 May;22(5):647-62. doi: 10.1093/icvts/ivv380. Epub 2016 Jan 26.

    PMID: 26819269BACKGROUND

  • Anastasiadis K, Antonitsis P, Asteriou C, Deliopoulos A, Argiriadou H. Modular minimally invasive extracorporeal circulation ensures perfusion safety and technical feasibility in cardiac surgery; a systematic review of the literature. Perfusion. 2022 Nov;37(8):852-862. doi: 10.1177/02676591211026514. Epub 2021 Jun 17.

    PMID: 34137323BACKGROUND

  • COMICS investigators, The COMICS investigators. Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS). Perfusion. 2021 May;36(4):388-394. doi: 10.1177/0267659120946731. Epub 2020 Aug 12.

    PMID: 32781894BACKGROUND

  • Wahba A, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Puis L; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):210-251. doi: 10.1093/ejcts/ezz267. No abstract available.

    PMID: 31576396BACKGROUND

  • Ranucci M, Johnson I, Willcox T, Baker RA, Boer C, Baumann A, Justison GA, de Somer F, Exton P, Agarwal S, Parke R, Newland RF, Haumann RG, Buchwald D, Weitzel N, Venkateswaran R, Ambrogi F, Pistuddi V. Goal-directed perfusion to reduce acute kidney injury: A randomized trial. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1918-1927.e2. doi: 10.1016/j.jtcvs.2018.04.045. Epub 2018 Apr 18.

    PMID: 29778331BACKGROUND

  • Anastasiadis K, Argiriadou H, Deliopoulos A, Antonitsis P. Minimal invasive extracorporeal circulation (MiECC): the state-of-the-art in perfusion. J Thorac Dis. 2019 Jun;11(Suppl 10):S1507-S1514. doi: 10.21037/jtd.2019.01.66. No abstract available.

    PMID: 31293801BACKGROUND

  • Kowalewski M, Pawliszak W, Raffa GM, Malvindi PG, Kowalkowska ME, Zaborowska K, Kowalewski J, Tarelli G, Taggart DP, Anisimowicz L. Safety and efficacy of miniaturized extracorporeal circulation when compared with off-pump and conventional coronary artery bypass grafting: evidence synthesis from a comprehensive Bayesian-framework network meta-analysis of 134 randomized controlled trials involving 22 778 patients. Eur J Cardiothorac Surg. 2016 May;49(5):1428-40. doi: 10.1093/ejcts/ezv387. Epub 2015 Nov 3.

    PMID: 26537755BACKGROUND

  • Anastasiadis K, Antonitsis P, Papazisis G, Haidich B, Liebold A, Punjabi P, Gunaydin S, El-Essawi A, Rao V, Serrick C, Condello I, Nasso G, Bozok S, Daylan A, Argiriadou H, Deliopoulos A, Karapanagiotidis G, Ashkanani F, Moorjani N, Cale A, Erdoes G, Bennett M, Starinieri P, Carrel T, Murkin J. Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients undergoing cardiac surgery (MiECS): Rationale and design of a multicentre randomised trial. Perfusion. 2025 May;40(4):923-932. doi: 10.1177/02676591241272009. Epub 2024 Aug 1.

    PMID: 39089011BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow Obstruction

Study Officials

  • Kyriakos Anastasiadis, Professor

    Aristotle University Of Thessaloniki

    STUDY CHAIR

  • Polychronis Antonitsis, Assoc. Prof.

    Aristotle University Of Thessaloniki

    STUDY DIRECTOR

Central Study Contacts

Georgios Papazisis, Assoc. Prof.

CONTACT

+30 2310999323papazisg@auth.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 4, 2022

Study Start

May 26, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)DE(3)CA(1)IT(2)TU(3)GB(3)