Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-03 @ 6:04 PM
Study NCT ID:
NCT04039594
Status:
UNKNOWN
Last Update Posted:
2019-08-06
First Post:
2019-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D006323', 'term': 'Heart Arrest'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-04', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '365 days'}, {'measure': 'Rate of successful weaning from ECMO', 'timeFrame': '30 days'}, {'measure': 'ECMO-related complications', 'timeFrame': '30 days', 'description': 'Bleeding requiring transfusion or surgery, stroke, sepsis, limb ischemia requiring intervention, system or cannula change'}, {'measure': 'Other complications', 'timeFrame': '30 days', 'description': 'Acute renal failure, ulcer bleeding, pneumonia, sepsis'}, {'measure': 'Duration stay at ICU and hospital', 'timeFrame': '365 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extracorporeal life support, extracorporeal membrane oxygenation, cardiogenic shock, cardiac arrest'], 'conditions': ['Cardiogenic Shock', 'Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Venoarterial extracorporeal membrane oxygenation (VA ECMO)-also referred to as extracorporeal life support-is a form of temporary mechanical circulatory support and simultaneous extracorporeal gas exchange. The objective of this observational, cohort study is to evaluate the short-term and long-term outcomes of patients with VA ECMO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving VA ECMO for cardiopulmonary support', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients receiving VA ECMO for cardiopulmonary support\n\nExclusion Criteria:\n\nRefusal of consent'}, 'identificationModule': {'nctId': 'NCT04039594', 'briefTitle': 'Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation', 'orgStudyIdInfo': {'id': '2019027X'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECMO', 'interventionNames': ['Device: VA ECMO']}], 'interventions': [{'name': 'VA ECMO', 'type': 'DEVICE', 'description': 'VA ECMO for cardiopulmonary support', 'armGroupLabels': ['ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaotong Hou, MD., PhD.', 'role': 'CONTACT', 'email': 'xt.hou@ccmu.edu.cn', 'phone': '8610 64456631'}, {'name': 'Xiaotong Hou, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaotong Hou, MD., PhD.', 'role': 'CONTACT', 'email': 'xt.hou@ccmu.edu.cn', 'phone': '8610 64456631'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Center for Cardiac Intensive Care', 'investigatorFullName': 'Xiaotong Hou', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}