Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
Study NCT ID:
NCT06781892
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2025-01-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest
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'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 909}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival at 30 days', 'timeFrame': '30 days after the cardiac arrest'}], 'secondaryOutcomes': [{'measure': 'Survival at 90 days', 'timeFrame': '90 days after the cardiac arrest'}, {'measure': 'Favorable neurological outcome at 30 days', 'timeFrame': '30 days after the cardiac arrest', 'description': 'Neurological outcome will be assessed with the modified Rankin Scale (mRS) which is a scale from 0 to 6 assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. The scale will will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).'}, {'measure': 'Favorable neurological outcome at 90 days', 'timeFrame': '90 days after the cardiac arrest', 'description': 'Neurological outcome will be assessed with the modified Rankin Scale (mRS) which is a scale from 0 to 6 assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. The scale will will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Out-of-hospital cardiac arrest', 'Defibrillation', 'Double-sequential defibrillation'], 'conditions': ['Cardiac Arrest (CA)']}, 'descriptionModule': {'briefSummary': 'The "Strategies for Defibrillation during Out-of-Hospital Cardiac Arrest" (STRAT-DEFI) trial is an investigator-initiated, individually randomized, 3-group clinical trial comparing standard anterior-lateral pad positioning with anterior-posterior positioning and double sequential defibrillation during adult out-of-hospital cardiac arrest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Out-of-hospital cardiac arrest\n2. Age ≥ 18 years\n3. ≥ 1 manual defibrillation attempt by emergency medical services\n4. Shockable rhythm as the last known rhythm\n5. Two manual defibrillators present on-site\n\nExclusion Criteria:\n\n1. Blunt trauma, penetrating trauma, or burn injury suspected to be the cause of the cardiac arrest\n2. Prior enrollment in the trial\n3. Posterior pad placement not deemed possible by on-site clinician'}, 'identificationModule': {'nctId': 'NCT06781892', 'acronym': 'STRAT-DEFI', 'briefTitle': 'Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '00006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anterior-lateral pad positioning', 'interventionNames': ['Other: Anterior-lateral pad positioning']}, {'type': 'EXPERIMENTAL', 'label': 'Anterior-posterior pad positioning', 'interventionNames': ['Other: Anterior-posterior pad positioning']}, {'type': 'EXPERIMENTAL', 'label': 'Double-sequential defibrillation', 'description': 'Anterior-lateral pad positioning combined with anterior-posterior pad positioning for a total of 4 pads and 2 shocks.', 'interventionNames': ['Other: Double-sequential defibrillation']}], 'interventions': [{'name': 'Anterior-lateral pad positioning', 'type': 'OTHER', 'description': 'Defibrillation pads positioned anterior-lateral', 'armGroupLabels': ['Anterior-lateral pad positioning']}, {'name': 'Anterior-posterior pad positioning', 'type': 'OTHER', 'description': 'Defibrillation pads positioned anterior-posterior', 'armGroupLabels': ['Anterior-posterior pad positioning']}, {'name': 'Double-sequential defibrillation', 'type': 'OTHER', 'description': 'Combination of anterior-lateral and anterior-posterior pad positioning for a total of 4 pads and 2 shocks.', 'armGroupLabels': ['Double-sequential defibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Thomas L Klitgaard', 'role': 'CONTACT', 'email': 'tlk@rn.dk', 'phone': '+4597662100'}], 'facility': 'Emergency Medical Services, the North Denmark Region', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus N', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jacob Steinmetz', 'role': 'CONTACT', 'email': 'jacob.steinmetz@regionh.dk', 'phone': '+4578414936'}], 'facility': 'Danish Air Ambulance, Danish Regions', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Bertram L Kirkegaard', 'role': 'CONTACT', 'email': 'bertramkirkegaard@clin.au.dk', 'phone': '+4578414848'}], 'facility': 'Prehospital Emergency Medical Services, Central Denmark Region', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2750', 'city': 'Ballerup Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Fredrik Folke', 'role': 'CONTACT', 'email': 'fredrik.folke@regionh.dk', 'phone': '+4538665000'}], 'facility': 'Copenhagen Emergency Medical Services, the Capital Region of Denmark', 'geoPoint': {'lat': 55.73165, 'lon': 12.36328}}, {'zip': '4700', 'city': 'Næstved', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Helle C Christensen', 'role': 'CONTACT', 'email': 'hcli@regionsjaelland.dk', 'phone': '+4557684100'}], 'facility': 'The Prehospital Center, Region Zealand', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'zip': '7100', 'city': 'Vejle', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Søren Mikkelsen', 'role': 'CONTACT', 'email': 'soeren.mikkelsen@rsyd.dk', 'phone': '+4576631000'}], 'facility': 'Emergency Medical Services, the Region of Southern Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'centralContacts': [{'name': 'Lars W Andersen', 'role': 'CONTACT', 'email': 'lwandersen@clin.au.dk', 'phone': '+4578414848'}, {'name': 'Bertram L Kirkegaard', 'role': 'CONTACT', 'email': 'bertramkirkegaard@clin.au.dk'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After publication of the last results (i.e., 1-year follow-up), all de-identified individual patient data will be made available for data sharing as allowed within Danish law. There will be no predetermined end date for the data sharing.', 'ipdSharing': 'YES', 'description': 'De-identified data. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data.', 'accessCriteria': 'Data will be available for any research purpose to all interested parties who have approval from an independent review committee if required and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Wiuff Andersen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lars Wiuff Andersen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}