REBOA for Out-of-hospital Cardiac Arrest

Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved.

The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Arrest
• Intervention / Treatment: Procedure: REBOA

Detailed Description

The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study.

Data collected:

• from enrolment of the patient until hospital arrival
• every 24 hours
• at discharge or 7 days post enrollment
• at 30 days post enrollment

The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Witnessed cardiac arrest
• Bystander or professional CPR within 5 minutes
• Refractory cardiac arrest

Exclusion Criteria:

• End Tidal CO2 <1,3 kPa
• Traumatic cardiac arrest
• Women with known pregnancy
• Patients with known terminal disease
• Patients with known do-not-attempt-CPR order
• Patients with overdose

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REBOA	Procedure: REBOA; Endovascular balloon occlusion of the aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Central blood pressure	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Return of spontaneous circulation (ROSC)	1 hour
Changes in cardiac rhythm following balloon inflation	1 hour
During procedure - time from first needle stick to successful sheath insertion	1 hour
During procedure - time from first needle stick to finalized balloon inflation	1 hour
End-tidal CO2 (EtCO2)	1 hour

Collaborators and Investigators

• Sponsor: neurescue

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: SafeStudy2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No