Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-27 @ 6:31 AM
Study NCT ID:
NCT02748668
Status:
TERMINATED
Last Update Posted:
2024-06-05
First Post:
2016-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Membrane Oxygenation (ECMO): Blood Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood is collected for analysis of cytokines and inflammatory cell patterns, and will be stored for future research.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}, 'targetDuration': '8 Days', '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': '2015-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2016-04-19', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Extracorporeal Membrane Oxygenation']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to predict outcomes of patients on extracorporeal membrane oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to clinical outcomes using data collected in the ECMO Registry at Spectrum Health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '500 patients on ECMO and 100 control patients will be enrolled into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'ECMO group:\n\nInclusion Criteria:\n\n* Greater than or equal to 18 years of age\n* Subject presents to the CTICU at Butterworth Campus, Spectrum Health and is critically ill in the ICU needing ECMO therapy.\n\nExclusion Criteria:\n\n* Subject is less than 18 years of age\n* Known prisoner\n\nControl Subjects:\n\nInclusion Criteria\n\n* Greater than 18 years of age\n* Without any known cardiovascular, lung, or autoimmune disease.\n\nExclusion Criteria:\n\n* Less than or equal to 18 years of age\n* Known cardiovascular, lung, or autoimmune disease'}, 'identificationModule': {'nctId': 'NCT02748668', 'briefTitle': 'Extracorporeal Membrane Oxygenation (ECMO): Blood Cells', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health West'}, 'officialTitle': 'Extracorporeal Membrane Oxygenation: Blood Cells', 'orgStudyIdInfo': {'id': '2014-255'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECMO', 'description': 'No intervention. Blood specimen collection.', 'interventionNames': ['Other: Blood specimen collection']}, {'label': 'Control', 'description': 'No intervention. Blood specimen collection.', 'interventionNames': ['Other: Blood specimen collection']}], 'interventions': [{'name': 'Blood specimen collection', 'type': 'OTHER', 'armGroupLabels': ['Control', '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': 'Corewell Health West', 'class': 'OTHER'}, 'collaborators': [{'name': 'Van Andel Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director of Cardiovascular Research', 'investigatorFullName': 'Renzo Loyaga Rendon', 'investigatorAffiliation': 'Corewell Health West'}}}}