Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT05487612
Status:
RECRUITING
Last Update Posted:
2024-08-07
First Post:
2022-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite outcome of postoperative serious adverse events', 'timeFrame': '30 days after randomization following the index admission', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30 days after randomization following the index admission', 'description': 'All-cause mortality'}, {'measure': 'New-onset postoperative atrial fibrillation', 'timeFrame': 'Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.', 'description': 'Incidence of new-onset postoperative atrial fibrillation'}, {'measure': 'Rate of red blood cells transfusion', 'timeFrame': '30 days after randomization following the index admission', 'description': 'Units of red blood cells transfused'}, {'measure': 'Rate of platelet transfusion', 'timeFrame': '30 days after randomization following the index admission', 'description': 'Units of platelets transfused'}, {'measure': 'Rate of fresh frozen plasma transfusion', 'timeFrame': '30 days after randomization following the index admission', 'description': 'Units of fresh frozen plasma transfused'}, {'measure': 'Rate of cryoprecipitate transfusion', 'timeFrame': '30 days after randomization following the index admission', 'description': 'Units of cryoprecipitate transfused'}, {'measure': 'Activated Factor VII administration', 'timeFrame': '30 days after randomization following the index admission', 'description': 'Incidence of activated factor VII administration'}, {'measure': 'Fibrinogen administration', 'timeFrame': '30 days after randomization following the index admission', 'description': 'Incidence of fibrinogen administration'}, {'measure': 'Prothrombin complex concentrate administration', 'timeFrame': '30 days after randomization following the index admission', 'description': 'Incidence of prothrombin complex concentrate administration'}, {'measure': 'Time to discharge from cardiac ICU', 'timeFrame': 'Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.', 'description': 'Time to discharge from cardiac ICU'}, {'measure': 'Time to discharge from hospital', 'timeFrame': 'Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.', 'description': 'Time to discharge from hospital'}, {'measure': 'Delirium', 'timeFrame': 'Up to 5 days postoperatively', 'description': 'Incidence of postoperative delirium'}, {'measure': 'Health-Related Quality of Life (HRQoL)', 'timeFrame': '90 days after randomization', 'description': 'HRQoL assessed with EQ-5D questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary bypass', 'Extracorporeal circulation', 'Minimal invasive extracorporeal circulation', 'Coronary artery bypass grafting', 'Aortic valve replacement'], 'conditions': ['Coronary Artery Disease', 'Aortic Valve Stenosis', 'Extracorporeal Circulation; Complications']}, 'referencesModule': {'references': [{'pmid': '26819269', 'type': 'BACKGROUND', 'citation': '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': '34137323', 'type': 'BACKGROUND', 'citation': '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': '32781894', 'type': 'BACKGROUND', 'citation': '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': '31576396', 'type': 'BACKGROUND', 'citation': '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': '29778331', 'type': 'BACKGROUND', 'citation': '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': '31293801', 'type': 'BACKGROUND', 'citation': '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': '26537755', 'type': 'BACKGROUND', 'citation': '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': '39089011', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://miectis.e-dendrite.com', 'label': 'MiECS Clinical Trial Registry by Dendrite'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMiniaturised 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.\n\nOur 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.\n\nStudy 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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Requirement for emergency or salvage operation.\n* Requirement for major aortic surgery (e.g. aortic root replacement).\n* Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products.\n* Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded).\n* Inability to give informed consent for the study (e.g. learning or language difficulties)."}, 'identificationModule': {'nctId': 'NCT05487612', 'acronym': 'MiECS', 'briefTitle': 'MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'MiECS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Minimal Invasive Extracorporeal Circulation (MiECC)', 'description': 'Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with Minimal Invasive Extracorporeal Circulation (MiECC).', 'interventionNames': ['Device: Minimal Invasive Extracorporeal Circulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Cardiopulmonary Bypass (cCPB)', 'description': 'Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with conventional cardiopulmonary bypass (cCPB)', 'interventionNames': ['Device: Conventional cardiopulmonary bypass']}], 'interventions': [{'name': 'Minimal Invasive Extracorporeal Circulation', 'type': 'DEVICE', 'description': 'Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).', 'armGroupLabels': ['Minimal Invasive Extracorporeal Circulation (MiECC)']}, {'name': 'Conventional cardiopulmonary bypass', 'type': 'DEVICE', 'description': 'Cardiac surgery with conventional cardiopulmonary bypass (cCPB).', 'armGroupLabels': ['Conventional Cardiopulmonary Bypass (cCPB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vivek Rao', 'role': 'CONTACT', 'email': 'Vivek.Rao@uhn.ca'}, {'name': 'Mousumi Mahanta', 'role': 'CONTACT', 'email': 'mailto:mousumi.mahanta@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '5275'}], 'facility': 'Perfusion Services University Health Network, Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '06869', 'city': 'Coswig', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Department of Cardiac Surgery', 'geoPoint': {'lat': 51.13204, 'lon': 13.58312}}, {'city': 'Göttingen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '89081', 'city': 'Ulm', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '54636', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Polychronis Antonitsis, Assoc. Prof.', 'role': 'CONTACT', 'email': 'antonits@auth.gr', 'phone': '+30 2310994871'}], 'facility': 'Cardiothoracic Department AHEPA University Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Nasso, MD', 'role': 'CONTACT', 'email': 'gnasso@gvmnet.it', 'phone': '+39 347 8159 178'}], 'facility': 'Department of Cardiac Surgery GVM Anthea Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '90135', 'city': 'Palermo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Department of Cardiac Surgery GVM Maria Eleonora Hospital', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Ankara', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Cardiovascular Surgery, Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ahmet Daylan, Ass. Prof.', 'role': 'CONTACT', 'email': 'ahmet.daylan@icloud.com'}, {'name': 'Sahin Bozok, Prof.', 'role': 'CONTACT', 'email': 'sahinboz@yahoo.com'}], 'facility': 'Department of Cardiovascular Surgery, Izmir Bakırçay University, Faculty of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': 'CB2 0AY', 'city': 'Cambridge', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United Kingdom', 'facility': 'Department of Cardiac Surgery, Royal Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'HU16 5JQ', 'city': 'Hull', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United Kingdom', 'facility': 'Deparment of Cardiac Surgery, Castle Hill Hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'W120HS', 'city': 'London', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United Kingdom', 'facility': 'Department of Cardiothoracic Surgery, Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Georgios Papazisis, Assoc. Prof.', 'role': 'CONTACT', 'email': 'papazisg@auth.gr', 'phone': '+30 2310999323'}], 'overallOfficials': [{'name': 'Kyriakos Anastasiadis, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Aristotle University Of Thessaloniki'}, {'name': 'Polychronis Antonitsis, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minimal Invasive Extracorporeal Technologies International Society (MiECTiS)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}