REBOA for Out-of-hospital Cardiac Arrest

Neurescue

Status: Withdrawn

Conditions: Cardiac Arrest

Treatments: Procedure: REBOA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04491903

SafeStudy2

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

REBOA

Experimental group

Treatment:

Procedure: REBOA