MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
NCT ID: NCT05487612
Last Updated: 2024-08-07
Study Results
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Basic Information
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RECRUITING
NA
1300 participants
INTERVENTIONAL
2022-05-26
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Minimal Invasive Extracorporeal Circulation
Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).
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)
Conventional cardiopulmonary bypass
Cardiac surgery with conventional cardiopulmonary bypass (cCPB).
Interventions
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Minimal Invasive Extracorporeal Circulation
Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).
Conventional cardiopulmonary bypass
Cardiac surgery with conventional cardiopulmonary bypass (cCPB).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
85 Years
ALL
No
Sponsors
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Minimal Invasive Extracorporeal Technologies International Society (MiECTiS)
UNKNOWN
Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Principal Investigators
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Kyriakos Anastasiadis, Professor
Role: STUDY_CHAIR
Aristotle University Of Thessaloniki
Polychronis Antonitsis, Assoc. Prof.
Role: STUDY_DIRECTOR
Aristotle University Of Thessaloniki
Locations
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Perfusion Services University Health Network, Toronto General Hospital
Toronto, , Canada
Department of Cardiac Surgery
Coswig, , Germany
Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen
Göttingen, , Germany
Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital
Ulm, , Germany
Cardiothoracic Department AHEPA University Hospital
Thessaloniki, , Greece
Department of Cardiac Surgery GVM Anthea Hospital
Bari, , Italy
Department of Cardiac Surgery GVM Maria Eleonora Hospital
Palermo, , Italy
Department of Cardiovascular Surgery, Ankara City Hospital
Ankara, , Turkey (Türkiye)
Department of Cardiovascular Surgery, Izmir Bakırçay University, Faculty of Medicine
Izmir, , Turkey (Türkiye)
Department of Cardiac Surgery, Royal Papworth Hospital
Cambridge, , United Kingdom
Deparment of Cardiac Surgery, Castle Hill Hospital
Hull, , United Kingdom
Department of Cardiothoracic Surgery, Hammersmith Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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MiECS Clinical Trial Registry by Dendrite
Other Identifiers
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MiECS
Identifier Type: -
Identifier Source: org_study_id
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