Trials / Withdrawn
WithdrawnNCT05236920
Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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 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).
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 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. The aims of UPFRONT are: 1. To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA 2. To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device | In-hospital use of a REBOA catheter device during advanced cardiac life support |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2022-10-31
- Completion
- 2022-10-31
- First posted
- 2022-02-11
- Last updated
- 2023-03-20
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05236920. Inclusion in this directory is not an endorsement.