Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT06299969
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2023-12-29', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': '3 weeks', 'description': 'Death/Survival at discharge'}], 'secondaryOutcomes': [{'measure': 'CPC score', 'timeFrame': '3 weeks', 'description': 'Cerebral performance category'}, {'measure': 'MRS', 'timeFrame': '3 weeks', 'description': 'Modified ranking scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OHCA', 'Out-of-hospital cardiac arrest', 'In-hospital cardiac arrest', 'Resuscitation', 'Cardiac arrest center', 'Feedback intervention', 'Acute care medicine'], 'conditions': ['Out-Of-Hospital Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA).', 'detailedDescription': 'With around 70,000 cases per year, out-of-hospital cardiac arrest (OHCA) is one of the most common causes of death in Germany. Only less than 10% of patients with an OHCA can currently be discharged with a satisfactory neurological outcome. The FITT-OHCA trial is a quality management project and collects data from Cardiac Arrest Centres on pre-hospital care and early post-resuscitation treatment in a standardized manner. The aim is to optimize the treatment process in patients following successful prehospital resuscitation through systematic data collection and feedback to the members of the rescue and treatment chain. The study includes cluster randomization of the participating hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated after out-of-hospital cardiac arrest', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients after cardiac arrest\n\nExclusion Criteria:\n\n* refused register participation by patient or legal representative'}, 'identificationModule': {'nctId': 'NCT06299969', 'acronym': 'FITT-OHCA', 'briefTitle': 'Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'St.Bernward Hospital'}, 'officialTitle': 'Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest (FITT-OHCA)', 'orgStudyIdInfo': {'id': 'StBernwardH'}}, 'contactsLocationsModule': {'locations': [{'zip': '31134', 'city': 'Hildesheim', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karl H Scholz, MD', 'role': 'CONTACT', 'email': 'k.scholz@fitt-stemi.de', 'phone': '+4955139', 'phoneExt': '64940'}, {'name': 'Sebastian Riedel', 'role': 'CONTACT', 'email': 's.riedel@bernward-khs.de', 'phone': '+4955139', 'phoneExt': '64940'}], 'facility': 'St Bernward Hospital', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}], 'centralContacts': [{'name': 'Karl H Scholz, MD', 'role': 'CONTACT', 'email': 'k.scholz@fitt-stemi.de', 'phone': '+4955139', 'phoneExt': '64940'}, {'name': 'Thomas Meyer, MD', 'role': 'CONTACT', 'email': 'thomas.meyer@med.uni-goettingen.de', 'phone': '+4955139', 'phoneExt': '64940'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St.Bernward Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Center Goettingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Karl Heinrich Scholz', 'investigatorAffiliation': 'St.Bernward Hospital'}}}}