Status:
WITHDRAWN
Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Cardiac Arrest, Out-Of-Hospital
Ventricular Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
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 minute...
Eligibility Criteria
Inclusion
- Apparent age between 18 - 70 years.
- OHCA defined as receiving professional CPR or AED defibrillation
- OHCA witnessed by bystanders or professional rescuers / UED personnel
- VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA
- Total time pulseless \> 10 minutes
Exclusion
- Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living
- Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.)
- Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest
- Do-Not-Resuscitate order or comfort care measures in place prior to enrollment
- Special populations (pregnant, prisoner, or cognitively impaired)
- Total time pulseless greater than 20 minutes
- Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05236920
Start Date
October 1 2022
End Date
October 31 2022
Last Update
March 20 2023
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