Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-30 @ 5:05 AM
Study NCT ID:
NCT07031466
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Outcome in Patients After eCPR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}, {'id': 'C000657744', 'term': 'postintensive care syndrome'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life (SF-36)', 'timeFrame': '30 days', 'description': 'Quality of Life in patients after eCPR will be assessed using the SF-36 questionnaire 30 days after eCPR'}, {'measure': 'Quality of Life (EQ-5D)', 'timeFrame': '30 days', 'description': 'Quality of Life in patients after eCPR will be assessed using the EQ-5D questionnaire 30 days after eCPR'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '30 days', 'description': 'Hospital Anxiety and Depression Scale (HADS) in patients after eCPR will be assessed using the EQ-5D questionnaire 30 days after eCPR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extracorporeal membrane oxygenation (ECMO)', 'extracorporeal cardiopulmonary resuscitation (eCPR)', 'Quality of Life', 'out-of-hospital cardiac arrest (OHCA)', 'Post-Intensive Care Syndrome (PICS)'], 'conditions': ['Cardiac Arrest (CA)']}, 'descriptionModule': {'briefSummary': 'This study consists of two parts - retrospective and prospective. The aim of this study is to assess the quality of life in bio-psycho-social dimensions in patients after eCPR (extracorporeal cardiopulmonary resuscitation), in relation to their neurological outcome after the end of treatment and discharge from the Ostrava University Hospital (FNO). The study will focus on patients who underwent extracorporeal membrane oxygenation (ECMO) support after out-of-hospital cardiac arrest (OHCA) in the years 2022-2024.', 'detailedDescription': 'Retrospective study Quantitative evaluation using data analysis from documentation. Patients on ECMO after OHCA in the period 1. 1. 2022 - 31. 12. 2024 will be evaluated based on data from the documentation. Analysis of data from the documentation of selected patients will be performed, evaluating demographic data, comorbidities, duration of ECMO support, mortality, Cerebral Performance Category (CPC) score 30 days after CPR.\n\nProspective study Quantitative assessment using validated questionnaire tools Patients connected to ECMO after OHCA in the period 1. 1. 2022 - 31. 12. 2024, in whom a CPC score \\>3 was detected after the 30th day from cardiac arrest and who were discharged from the FNO. As part of patient dispensary, these patients are electively invited to the PICS outpatient clinic in the FNO Ostrava. Individual interviews (filling out questionnaires) will be performed after obtaining informed consent in the Post-Intensive Care Syndrome (PICS) outpatient clinic at the University Hospital Ostrava, or telephone interviews conducted by the attending physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent eCPR at the University Hospital Ostrava', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who underwent eCPR after OHCA at University Hospital Ostrava\n* Hospitalised in the period from 1. 1. 2022 to 31. 12. 2024\n* Ability to undergo an interview personally or a family member able to provide information\n* Signed informed consent\n\nExclusion Criteria:\n\n* Language barrier\n* Acute serious mental or somatic disease making the interview not feasible'}, 'identificationModule': {'nctId': 'NCT07031466', 'briefTitle': 'Treatment Outcome in Patients After eCPR', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Treatment Outcome in Patients After eCPR', 'orgStudyIdInfo': {'id': 'FNO-KARIM-eCPR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective eCPR group', 'description': 'Retrospective analysis of eCPR patients', 'interventionNames': ['Other: Retrospective analysis of assigned treatment']}, {'label': 'Prospective eCPR group', 'description': 'Prospective analysis of eCPR patients', 'interventionNames': ['Other: Quality of Life (SF-36)', 'Other: Quality of Life (EQ-5D)', 'Other: Hospital Anxiety and Depression (HADS)']}], 'interventions': [{'name': 'Retrospective analysis of assigned treatment', 'type': 'OTHER', 'description': 'Retrospective analysis of assigned treatment will be performed', 'armGroupLabels': ['Retrospective eCPR group']}, {'name': 'Quality of Life (SF-36)', 'type': 'OTHER', 'description': 'The quality of life will be assessed using the SF-36 (Short-Form Health Subject Questionnaire).', 'armGroupLabels': ['Prospective eCPR group']}, {'name': 'Quality of Life (EQ-5D)', 'type': 'OTHER', 'description': 'The quality of life will be assessed using the EQ-5D (European Quality of Life Questionnaire)', 'armGroupLabels': ['Prospective eCPR group']}, {'name': 'Hospital Anxiety and Depression (HADS)', 'type': 'OTHER', 'description': 'Hospital Anxiety and Depression will be assessed using the HADS (Hospital Anxiety and Depression Scale)', 'armGroupLabels': ['Prospective eCPR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700 30', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'facility': 'University of Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '708 52', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'overallOfficials': [{'name': 'Michaela Lišková, Bc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available to other researchers. The data may be provided upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}