Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 3:15 AM
Study NCT ID:
NCT07351435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Caribbean Registry of Extracorporeal Membrane Oxygenation (ECMO) From the University Hospital in Martinique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D012805', 'term': 'Sickle Cell Trait'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2033-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality at 30 days', 'timeFrame': 'from canula implantation to 30 days afterwards', 'description': 'Number of deceased participants as assessed at 30 days after ECMO implantation'}], 'secondaryOutcomes': [{'measure': 'Number of participants with major adverse events', 'timeFrame': 'From canula implantation to up to 6 months after ECMO implantation', 'description': 'Major Adverse events (AE; numbers and rates) as assessed by the consensus statement of the mechanical circulatory support academic research consortium'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute heart failure', 'respiratory insufficiency'], 'conditions': ['Cardiogenic Shock', 'Malignant Arrhythmias', 'Ischemic or Valvular Heart Failure', 'Drepanocytosis and Thoracic Syndrome', 'Pulmonary Thromboembolisms', 'Sepsis', 'ARDS (Acute Respiratory Distress Syndrome)', 'Intoxication', 'Cardiac Arrest (CA)', 'Postcardiotomy Heart Failure', 'Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '40298907', 'type': 'BACKGROUND', 'citation': 'Serpa Neto A, Higgins AM, Bailey MJ, Anderson S, Bernard S, Fulcher BJ, Jones A, Linke NJ, Board JV, Brodie D, Buhr H, Burrell AJC, Cooper DJ, Fan E, Fraser JF, Gattas DJ, Hopper IK, Huckson S, Litton E, McGuinness SP, Nair P, Orford N, Parke RL, Pellegrino VA, Pilcher DV, Dicker C, Reddi BAJ, Stub D, Trapani TV, Udy AA, Hodgson CL; EXCEL Study Investigators on behalf of the International ECMO Network (ECMONet). Long-Term Functional Outcomes in the First 12 Months After VA-ECMO in Adult Patients: A Prospective, Multicenter Study. Circ Heart Fail. 2025 Jun;18(6):e012476. doi: 10.1161/CIRCHEARTFAILURE.124.012476. Epub 2025 Apr 29.'}, {'pmid': '40340843', 'type': 'BACKGROUND', 'citation': 'Ling RR, Chen Y, Low CJW, Agerstrand C, Jung JS, Lim SL, Lorusso R, Mueller T, Okada Y, Tonna JE, Shekar K, Brodie D, MacLaren G, Ramanathan K. Left ventricular unloading during extracorporeal cardiopulmonary resuscitation: a target trial emulation of the ELSO registry. Crit Care. 2025 May 8;29(1):186. doi: 10.1186/s13054-025-05345-3.'}, {'pmid': '40644625', 'type': 'BACKGROUND', 'citation': 'Grazioli A, Plazak M, Willsey K, Rabin J, Rector RP, Belyayev L, Lankford AS, Scalea TM, Shah A, Taylor BS, Gladwin MT. Outcomes and survival prediction in adults with sickle cell disease treated with extracorporeal membrane oxygenation. Blood Adv. 2025 Oct 14;9(19):4881-4890. doi: 10.1182/bloodadvances.2025016368.'}, {'pmid': '40704940', 'type': 'BACKGROUND', 'citation': 'Labrada L, Alarfaj M, Tran L, Granger H, Hernandez A, Hu J, Baker J, Grandin EW, Delgado AA, Katz JN, Miller PE, Alviar CL, Osborn E, Bacchetta MD, Lindenfeld J, Shah Z, Rali AS. Optimal ECLS Support in Mixed Cardiogenic and Septic Shock: An ELSO Registry Analysis. JACC Adv. 2025 Oct;4(10 Pt 1):101965. doi: 10.1016/j.jacadv.2025.101965. Epub 2025 Jul 23.'}, {'pmid': '40823501', 'type': 'BACKGROUND', 'citation': 'Wang L, Wang K, Wang Y, Yang F, Li C, Hao X, Du Z, Rycus PT, Tonna JE, Fan E, Wang H, Hou X. A simple VA-ECMO bundle in adult patients with cardiogenic shock: an analysis of ELSO registry. EClinicalMedicine. 2025 Aug 7;87:103423. doi: 10.1016/j.eclinm.2025.103423. eCollection 2025 Sep.'}, {'pmid': '41506589', 'type': 'BACKGROUND', 'citation': 'Baldetti L, Pontillo D, Capoccia M, Kowalewski M, Tonna JE, Broman M, Conrad SA, Swol J, Scandroglio AM, Brewer JM, Maybauer MO, Lorusso R. Venopulmonary extracorporeal life support: An Extracorporeal Life Support Organization registry analysis. J Heart Lung Transplant. 2026 Jan 6:S1053-2498(25)02480-5. doi: 10.1016/j.healun.2025.12.024. Online ahead of print.'}, {'pmid': '38648078', 'type': 'BACKGROUND', 'citation': 'Moynihan KM, Sharma M, Mehta A, Lillie J, Ziegenfuss M, Festa M, Chan T, Thiagarajan R. Race-Conscious Research Using Extracorporeal Life Support Organization Registry Data: A Narrative Review. ASAIO J. 2024 Sep 1;70(9):721-733. doi: 10.1097/MAT.0000000000002206. Epub 2024 Apr 18.'}, {'pmid': '39360897', 'type': 'BACKGROUND', 'citation': 'Remy T, Jegard J, Chenouard A, Maminirina P, Liet JM, Couec ML, Joram N, Bourgoin P. Characteristics and outcomes of children and young adults with sickle cell disease supported with extracorporeal membrane oxygenation (ECMO): An updated analysis of the ELSO registry. Artif Organs. 2025 Mar;49(3):508-515. doi: 10.1111/aor.14880. Epub 2024 Oct 3.'}, {'pmid': '39382377', 'type': 'BACKGROUND', 'citation': 'Mazzeffi M, Zaaqoq A, Curley J, Buchner J, Wu I, Beller J, Teman N, Glance L. Survival After Extracorporeal Cardiopulmonary Resuscitation Based on In-Hospital Cardiac Arrest and Cannulation Location: An Analysis of the Extracorporeal Life Support Organization Registry. Crit Care Med. 2024 Dec 1;52(12):1906-1917. doi: 10.1097/CCM.0000000000006439. Epub 2024 Oct 9.'}, {'pmid': '41193107', 'type': 'BACKGROUND', 'citation': 'Kanwar MK, Shah P, Cascino T, Grinstein J, Goldstein D, Hernandez-Montfort J, Li S, Uriel N, Molina E, Cantor R, Komanduri B, Pagani FD, Kirklin JK. Impact of Preoperative Temporary Mechanical Circulatory Support on Durable LVAD Outcomes: An Analysis of The Society of Thoracic Surgeons National Intermacs Database. JACC Heart Fail. 2025 Nov;13(11):102671. doi: 10.1016/j.jchf.2025.102671. Epub 2025 Oct 8.'}]}, 'descriptionModule': {'briefSummary': "The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing VV, VA or VAV ECMO implantation in the French West Indies and Guiana. All patients undergoing ECMO implantation will be prospectively registered.", 'detailedDescription': 'In the Caribbean region, access to advanced cardiac interventions faces difficulties owing to unequal distribution of health care resources, medical shortages and distance between health care centers in various islands.\n\nAt the University Hospital of Martinique (UHM) in Fort de France, a mobile ECMO team is available 24h a day, 7 days a week, for cardiopulmonary mechanical support in the French Overseas Territories and neighboring islands.\n\nImplantation of veno-venous or veno-arterial (VV or VA) ECMO can be performed at the UHM or at remote hospitals. Some patients on VA-ECMO are transfered by airflight to the UHM and/or to French mainland whenever cardiac transplantation is indicated.\n\nSince 2010, the ECMO-UHM database is a prospective event-driven registry housed and updated by the HeartTeam (perfusionnists, emergency and ICU physicians, cardiac surgeons, cardiothoracic anesthesiologists, cardiologists).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients implanted with a VV-ECMO, VA-ECMO or VAV-ECMO device by the UHM HeartTeam', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients implanted with a veno-venous extracorporeal membrane oxygenation device or extracorporeal membrane oxygenation device by the HeartTeam from the University Hospital of Martinique (UHM) from January 2010\n\nExclusion Criteria:\n\n* Patients with incomplete data (primary endpoint and less than 80% secondary study outcomes)'}, 'identificationModule': {'nctId': 'NCT07351435', 'briefTitle': 'The Caribbean Registry of Extracorporeal Membrane Oxygenation (ECMO) From the University Hospital in Martinique', 'organization': {'class': 'OTHER', 'fullName': 'University of Genova'}, 'officialTitle': 'The Caribbean Registry of Extracorporeal Membrane Oxygenation (ECMO) From the University Hospital in Martinique', 'orgStudyIdInfo': {'id': '18-11-2025 CHUM CVT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VV-ECMO', 'description': 'Patients with respiratory failure'}, {'label': 'VA-ECMO', 'description': 'Patients with cardiac failure or combined cardiopulmonary failure'}, {'label': 'VAV-ECMO', 'description': 'Patients initially on VV or VA-ECMO who require additional respiratory/circulatory support'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marc LICKER, MD', 'role': 'CONTACT', 'email': 'marc.licker@unige.ch', 'phone': '+41796234488'}, {'name': 'Jeremy MAZILE, BC perfusionnist', 'role': 'CONTACT', 'email': 'jermy.bazile@chu-martinique.fr'}], 'overallOfficials': [{'name': 'Marc LICKER, BC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Martinique'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'from January 2026 to December 2032', 'ipdSharing': 'YES', 'description': 'only IPD used in the results publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Genova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Professor at the University of Geneva, Consultant in the department of Cardiothoracic Anesthesia and Critical Care at the University Hospital of Martinique', 'investigatorFullName': 'Marc Licker', 'investigatorAffiliation': 'University of Genova'}}}}