REBOA for Out-of-hospital Cardiac Arrest

April 29, 2021 updated by: neurescue

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Withdrawn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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Central blood pressure
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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