Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT05236920
Status:
WITHDRAWN
Last Update Posted:
2023-03-20
First Post:
2022-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None. Masking is not possible.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study will not take place at this time.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to successful deployment of device', 'timeFrame': 'Up to 10 minutes', 'description': 'The device is successfully deployed when it raises the mean arterial pressure'}], 'secondaryOutcomes': [{'measure': 'Return of spontaneous circulation (ROSC)', 'timeFrame': 'Up to 60 minutes', 'description': 'ROSC is when the heart begins beating on its own'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cardiac arrest', 'out of hospital cardiac arrest', 'REBOA'], 'conditions': ['Cardiac Arrest, Out-Of-Hospital', 'Ventricular Fibrillation', 'Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'Single center randomized-controlled trial in out-of-hospital cardiac arrest (OHCA) patients. This study will investigate the feasibility and utility of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure using a REBOA catheter device in patients who have experienced an OHCA and have not regained return of spontaneous circulation (ROSC).', 'detailedDescription': 'Victims arriving to, or experiencing witnessed Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT) out of hospital cardiac arrest in, the UAB emergency department with greater than 10 minutes of conventional ACLS will be eligible. The study population will consist of forty (40) subjects randomized to either continued contemporary standard of care (ACLS), or ACLS plus the administration of a REBOA catheter device.\n\nThe aims of UPFRONT are:\n\n1. To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA\n2. To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Apparent age between 18 - 70 years.\n2. OHCA defined as receiving professional CPR or AED defibrillation\n3. OHCA witnessed by bystanders or professional rescuers / UED personnel\n4. VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA\n5. Total time pulseless \\> 10 minutes\n\nExclusion Criteria:\n\n1. Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living\n2. Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.)\n3. Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest\n4. Do-Not-Resuscitate order or comfort care measures in place prior to enrollment\n5. Special populations (pregnant, prisoner, or cognitively impaired)\n6. Total time pulseless greater than 20 minutes\n7. Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since'}, 'identificationModule': {'nctId': 'NCT05236920', 'acronym': 'UP-FRONT', 'briefTitle': 'Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)', 'orgStudyIdInfo': {'id': '300007924'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS)'}, {'type': 'EXPERIMENTAL', 'label': 'Standard Care Plus Intervention', 'description': 'Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention', 'interventionNames': ['Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device']}], 'interventions': [{'name': 'Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device', 'type': 'DEVICE', 'otherNames': ['REBOA procedure'], 'description': 'In-hospital use of a REBOA catheter device during advanced cardiac life support', 'armGroupLabels': ['Standard Care Plus Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael C Kurz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and Vice-Chair for Research, Department of Emergency Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigator has no plans to share individual participant data with other researchers. Any future use of the data will be proposed to and approved by the Principal Investigator, and will require IRB approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Vice Chair for Research', 'investigatorFullName': 'Michael C. Kurz', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}