Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 5:27 PM
Study NCT ID:
NCT05155904
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2021-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Veno Arterial ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'Up to hospital discharge, an average of 1 month', 'description': 'In-hospital mortality of patients with : veno arterial (VA) extra corporeal membrane oxygenation (ECMO)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['veno arterial', 'mortality', 'extra corporeal membrane oxygenation'], 'conditions': ['Mortality', 'Extra Corporeal Membrane Oxygenation']}, 'descriptionModule': {'briefSummary': 'veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. In spite of the application of international guidelines, the mortality of patients with VA remains high with an admitted survival rate at hospital discharge at 40%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted in Amiens hospital university beneficing of a veno arterial (VA) extra corporeal membrane oxygenation (ECMO).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age : ≥ 18\n* Patient with a VA ECMO\n\nExclusion Criteria:\n\n* age\\<18'}, 'identificationModule': {'nctId': 'NCT05155904', 'acronym': 'ECMOCARD', 'briefTitle': 'Outcomes of Veno Arterial ECMO', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'In-hospital Mortality of Patients With Veno Arterial ECMO: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'PI2021_843_204'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Osama ABOU ARAB', 'role': 'CONTACT', 'email': 'abouarab.osama@chu-amiens.fr'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Osama Abou Arab, MD', 'role': 'CONTACT', 'email': 'abouarab.osama@chu-amiens.fr', 'phone': '03 22 08 78 36'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}