Utility and Procedural Feasibility of REBOA Operationaliz... | NCT05236920

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study will not take place at this time.

Expanded Access Info

Start Date

Oct 1, 2022Estimated

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Oct 31, 2022Actual

First Submitted Date

Jan 14, 2022

First Submission Date that Met QC Criteria

Feb 2, 2022

First Posted Date

Feb 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 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:

To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA
To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Care	No Intervention	Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS)
Standard Care Plus Intervention	Experimental	Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention	Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device	Device	In-hospital use of a REBOA catheter device during advanced cardiac life support	Standard Care Plus Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to successful deployment of device	The device is successfully deployed when it raises the mean arterial pressure	Up to 10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Return of spontaneous circulation (ROSC)	ROSC is when the heart begins beating on its own	Up to 60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael C Kurz, MD	Professor and Vice-Chair for Research, Department of Emergency Medicine	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D058687	Out-of-Hospital Cardiac Arrest
D014693	Ventricular Fibrillation
D017180	Tachycardia, Ventricular
D006323	Heart Arrest

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D013610	Tachycardia
D000075224	Cardiac Conduction System Disease