Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-23 @ 3:46 PM
Study NCT ID:
NCT02280460
Status:
TERMINATED
Last Update Posted:
2024-06-05
First Post:
2014-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECMO: Optimization of Its Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 921}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Study was not able to achieve primary objective and there is no intention to work towards its achievement', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': '48 hours'}, {'measure': 'In-house mortality', 'timeFrame': '30 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extracorporeal Membrane Oxygenation Complication']}, 'referencesModule': {'references': [{'pmid': '490805', 'type': 'BACKGROUND', 'citation': 'Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, Morris AH, Peirce EC 2nd, Thomas AN, Proctor HJ, Drinker PA, Pratt PC, Bagniewski A, Miller RG Jr. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA. 1979 Nov 16;242(20):2193-6. doi: 10.1001/jama.242.20.2193.'}, {'pmid': '19762075', 'type': 'BACKGROUND', 'citation': 'Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'To create a local registry for ECMO patients.', 'detailedDescription': 'To create a local registry of retrospective and prospective patients on ECMO at Spectrum Health, Butterworth campus in order to optimize the use of ECMO therapy and to create algorithms to estimate the prognosis. ECMO patients will be compared to a control group of patients. Patient mortality will be assessed in-house, at 48 hours, 3 months, and 1 year after the start of ECMO therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Spectrum Health requiring ECMO therarpy. For the control, patients in the Intensive Care Unit at Spectrum Health will be considered.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18\n* requiring ECMO. For the control,Patients without ECMO admited to ICU.\n\nExclusion Criteria:\n\n* Age\\<18\n* Known prisoner of the state'}, 'identificationModule': {'nctId': 'NCT02280460', 'briefTitle': 'ECMO: Optimization of Its Use', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health West'}, 'officialTitle': 'Extracorporeal Membrane Oxygenation(ECMO): Optimization of Its Use', 'orgStudyIdInfo': {'id': '2014-194'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VA ECMO', 'description': 'Patients who are placed on VA ECMO.'}, {'label': 'VV ECMO', 'description': 'Patients who are placed on VV ECMO.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'overallOfficials': [{'name': 'Renzo Loyaga-Rendon, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health West'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renzo Loyaga Rendon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Corewell Health West', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Cardiovascular Research', 'investigatorFullName': 'Renzo Loyaga Rendon', 'investigatorAffiliation': 'Corewell Health West'}}}}