Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)

Ventricular Tachycardia Clinical Trial

— UP-FRONT  

Official title:

Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05236920
• Other study ID #: 300007924
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Apparent age between 18 - 70 years.

2. OHCA defined as receiving professional CPR or AED defibrillation

3. OHCA witnessed by bystanders or professional rescuers / UED personnel

4. VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA

5. Total time pulseless > 10 minutes

Exclusion Criteria:

1. Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living

2. Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.)

3. Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest

4. Do-Not-Resuscitate order or comfort care measures in place prior to enrollment

5. Special populations (pregnant, prisoner, or cognitively impaired)

6. Total time pulseless greater than 20 minutes

7. Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since

Related Conditions & MeSH terms

• Cardiac Arrest, Out-Of-Hospital
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to successful deployment of device	The device is successfully deployed when it raises the mean arterial pressure	Up to 10 minutes
Secondary	Return of spontaneous circulation (ROSC)	ROSC is when the heart begins beating on its own	Up to 60 minutes