Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-28 @ 7:31 PM
Study NCT ID:
NCT04491903
Status:
WITHDRAWN
Last Update Posted:
2021-05-04
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REBOA for Out-of-hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central blood pressure', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Return of spontaneous circulation (ROSC)', 'timeFrame': '1 hour'}, {'measure': 'Changes in cardiac rhythm following balloon inflation', 'timeFrame': '1 hour'}, {'measure': 'During procedure - time from first needle stick to successful sheath insertion', 'timeFrame': '1 hour'}, {'measure': 'During procedure - time from first needle stick to finalized balloon inflation', 'timeFrame': '1 hour'}, {'measure': 'End-tidal CO2 (EtCO2)', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved.\n\nThe objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.', 'detailedDescription': 'The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study.\n\nData collected:\n\n* from enrolment of the patient until hospital arrival\n* every 24 hours\n* at discharge or 7 days post enrollment\n* at 30 days post enrollment\n\nThe investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Witnessed cardiac arrest\n* Bystander or professional CPR within 5 minutes\n* Refractory cardiac arrest\n\nExclusion Criteria:\n\n* End Tidal CO2 \\<1,3 kPa\n* Traumatic cardiac arrest\n* Women with known pregnancy\n* Patients with known terminal disease\n* Patients with known do-not-attempt-CPR order\n* Patients with overdose'}, 'identificationModule': {'nctId': 'NCT04491903', 'briefTitle': 'REBOA for Out-of-hospital Cardiac Arrest', 'organization': {'class': 'INDUSTRY', 'fullName': 'neurescue'}, 'officialTitle': 'REBOA for Out-of-hospital Cardiac Arrest', 'orgStudyIdInfo': {'id': 'SafeStudy2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REBOA', 'interventionNames': ['Procedure: REBOA']}], 'interventions': [{'name': 'REBOA', 'type': 'PROCEDURE', 'description': 'Endovascular balloon occlusion of the aorta', 'armGroupLabels': ['REBOA']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'neurescue', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}