Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT04480151
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2020-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], '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': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation', 'timeFrame': 'Day 30 after Left Ventricular Assist Device (LVAD) implantation', 'description': 'Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation'}], 'secondaryOutcomes': [{'measure': 'Complication and rehabilitation under Short-term Mechanical Circulatory support', 'timeFrame': 'The day of Left Ventricular Assist Device (LVAD) implantation', 'description': 'Duration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry)'}, {'measure': 'Organ dysfunction before LVAD implantation', 'timeFrame': 'The day before LVAD implantation', 'description': 'Need for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \\[0= best outcome to 24 = worst outcome\\]'}, {'measure': 'complication Under LVAD', 'timeFrame': 'The day of Intensive Care Unit (ICU) discharge', 'description': 'bleeding, right ventricular dysfunction, vasoplegia'}, {'measure': 'SOFA score', 'timeFrame': 'The day of Short Term Mechanical Circulatory Support (STMCS) implantation', 'description': 'Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \\[0= best outcome to 24 = worst outcome\\]'}, {'measure': 'SOFA score', 'timeFrame': 'The day of LVAD implantation', 'description': 'Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \\[0= best outcome to 24 = worst outcome\\]'}, {'measure': 'SOFA score', 'timeFrame': 'Day 1 post LVAD implantation', 'description': 'Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \\[0= best outcome to 24 = worst outcome\\]'}, {'measure': 'SOFA score', 'timeFrame': 'Day 3 post LVAD implantation', 'description': 'Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \\[0= best outcome to 24 = worst outcome\\]'}, {'measure': 'SOFA score', 'timeFrame': 'Day 5 post LVAD implantation', 'description': 'Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \\[0= best outcome to 24 = worst outcome\\]'}, {'measure': 'SOFA score', 'timeFrame': 'Day 7 post LVAD implantation', 'description': 'Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \\[0= best outcome to 24 = worst outcome\\]'}, {'measure': 'Vital status', 'timeFrame': '1 month after LVAD implantation', 'description': 'mortality after LVAD implantation'}, {'measure': 'Vital status', 'timeFrame': '3 months after LVAD implantation', 'description': 'mortality after LVAD implantation'}, {'measure': 'Vital status', 'timeFrame': '6 months after LVAD implantation', 'description': 'mortality after LVAD implantation'}, {'measure': 'length of stay', 'timeFrame': 'up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)', 'description': 'Intensive Care Unit length of stay'}, {'measure': 'length of stay', 'timeFrame': 'up to hospital discharge (not more than 6 months after LVAD implantation)', 'description': 'hospital length of stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiogenic shock', 'end stage heart failure', 'bridge to bridge', 'bridge to decision', 'left ventricular assist device', 'IMPELLA™', 'ECLS'], 'conditions': ['Cardiogenic Shock', 'End-stage Heart Failure']}, 'descriptionModule': {'briefSummary': "In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).", 'detailedDescription': 'End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™ inserted via the axillary artery. The aim of this study is to compare the early rehabilitation and outcomes after LVAD implantation between patients previously treated by IMPELLA™ or ExtraCorporeal Life Support (ECLS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients implanted by IMPELLA™ pump or ECLS as a bridge to long duration LVAD between January 2012 and December 2018 in five university hospital centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge to long duration LVAD\n\nExclusion Criteria:\n\n* Patient refusing to give access to their medical chart\n* Guardianship and curactorship\n* Deprived of liberty\n* short term mechanical circulatory system weaned before LVAD implantation'}, 'identificationModule': {'nctId': 'NCT04480151', 'acronym': 'ECI-BLAD', 'briefTitle': 'ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device', 'orgStudyIdInfo': {'id': 'CHUBX 2020/37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IMPELLA™ alone as bridge to LVAD', 'description': 'patients assisted by IMPELLA™ pump alone during the days preceding the implantation of long term LVAD (at least 48 hours for patients for whom an ECLS was previously used)', 'interventionNames': ['Other: standard of care']}, {'label': 'ECLS alone or with IMPELLA™ as bridge to LVAD', 'description': 'patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD', 'interventionNames': ['Other: standard of care']}], 'interventions': [{'name': 'standard of care', 'type': 'OTHER', 'description': 'retrospective study: standard of care', 'armGroupLabels': ['ECLS alone or with IMPELLA™ as bridge to LVAD', 'IMPELLA™ alone as bridge to LVAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon-Bourgoigne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Alexandre OUATTARA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}