REBOA for Out-of-hospital Cardiac Arrest

NCT ID: NCT04491903

Last Updated: 2021-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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REBOA

Group Type EXPERIMENTAL

REBOA

Intervention Type PROCEDURE

Endovascular balloon occlusion of the aorta

Interventions

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REBOA

Endovascular balloon occlusion of the aorta

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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neurescue

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SafeStudy2

Identifier Type: -

Identifier Source: org_study_id

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