Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-26 @ 7:11 PM
Study NCT ID:
NCT05338593
Status:
COMPLETED
Last Update Posted:
2023-08-29
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'During intensive care treatment (Usually within 25 weeks)', 'description': 'Mortality rate under ongoing veno-venous extracorporeal membrane oxygenation over time'}], 'secondaryOutcomes': [{'measure': 'Major bleeding', 'timeFrame': 'During intensive care treatment (Usually within 25 weeks)', 'description': 'Number of patients with critical bleeding events during therapy, needing red blood cell transfusion'}, {'measure': 'critical device error', 'timeFrame': 'During intensive care treatment (Usually within 25 weeks)', 'description': 'Number of patients with a critical device errors of the veno-venous extracorporeal membrane oxygenation device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extracorporeal Membrane Oxygenation Complication', 'Outcome, Fatal']}, 'descriptionModule': {'briefSummary': 'In the context of the coronavirus (COVID-19) pandemic, healthcare systems worldwide faced an unprecedented shortage of severe ARDS. Critically affected patients were treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO) for complete respiratory failure early in the pandemic. Due to a shortage of resources in the sense of terminal equipment and adequately trained personnel with appropriate expertise in many countries and regions, a strict selection of suitable patients was made. Repeatedly, it was observed that patients under VV-ECMO also needed several weeks to recover sufficiently to generate device sufficient gas exchange. Due to the scarcity of VV-ECMO resources outside of the pandemic, the question arose whether a prolonged therapy still holds a sufficient prospect of success and what the course of treatment of such patients would be like.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nveno-venous extracorporeal membrane oxygenation\n\nExclusion Criteria:\n\nveno-arterial extracorporeal membrane oxygenation'}, 'identificationModule': {'nctId': 'NCT05338593', 'briefTitle': 'Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.', 'orgStudyIdInfo': {'id': 'prolonged VV-ECMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'prolonged veno-venous extracorporeal membrane oxygenation', 'description': 'Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.', 'interventionNames': ['Other: Outcome']}], 'interventions': [{'name': 'Outcome', 'type': 'OTHER', 'description': 'Mortality rate of prolonged therapy.', 'armGroupLabels': ['prolonged veno-venous extracorporeal membrane oxygenation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Armin N Flinspach, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JWGoethe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing patient data is not possible due to national and local legal restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Armin N. Flinspach', 'investigatorAffiliation': 'Goethe University'}}}}