Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

NCT04596514 · tracked via the Priya Life Science Denmark tracker

Sponsor

St. Olavs Hospital

Phase

Not applicable

Started

2021-06-07

Last updated

2026-07-17

Condition(s) studied

Cardiac Arrest

Investigational drug(s) / intervention(s)

REBOAusual procedure according to guidelines

REBOA: Resuscitative endovascular balloon occlusion of the aorta (REBOA)

usual procedure according to guidelines: Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines

Study summary

The primary aim of this trial is to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct treatment to advanced cardiovascular life support (ACLS) in patients with out-of-hospital cardiac arrest.

Out of hospital cardiac arrest (OHCA) carries a high mortality rate. The treatment of out-of-hospital cardiac arrest is ACLS as stated in the guidelines from the Norwegian Resuscitation Council and the European Resuscitation Guidelines.

Recently, REBOA has been proposed as an adjunct treatment in management of non-traumatic cardiac arrest patients, because thoracic aortic occlusion provides a redistribution of the cardiac output to organs proximal to the occlusion. Preclinical studies demonstrate that REBOA during CPR provide both increased coronary artery blood flow and perfusion pressure and increased rates of return of spontaneous circulation (ROSC).

This is the first prospective trial in the world to assess the efficacy of REBOA in non-traumatic cardiac arrest. The intervention is shown feasible in the pre-hospital setting. If this trial provides a signal of benefit in patients, this study could initiate further clinical research which could change current resuscitation practice world-wide.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * out-of-hospital cardiac arrest * non-traumatic cardiac arrest * less than 10 minutes from debut of arrest to start of basic or advanced cardiac life support * advanced cardiac life support is established and can be continued Exclusion Criteria: * traumatic cardiac arrest, including strangulation, electrocution and patients rescued from avalanches * accidental hypothermia with temperature \< 32 0C * suspected cerebral hemorrhage as etiology of the arrest * suspected non-traumatic hemorrhage as etiology of the arrest * pregnancy, obvious or suspected * patient included to the study site's E-CPR protocol * other factors as decided by the treatment team (environmental factors, safety factors and others)

Primary outcome measure(s)

Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes. — 60 minutes
Sustained ROSC means return of spontaneous circulation with a duration of at least 20 minutes.

Trial sites (11)

Facility	City	Region
Aarhus Base	Aarhus	Denmark
Billund HEMS-base	Billund	Denmark
Ringsted HEMS-base	Ringsted	Denmark
Skive HEMS	Skive	Denmark
Maggiore Hospital	Bologna	Italy
Haukeland University Hospital	Bergen	Norway
Drammen Hospital	Drammen	Norway
Lørenskog HEMS Unit	Oslo	Norway
Rapid response car - 119 Oslo	Oslo	Norway
Stavanger University Hospital	Stavanger	Norway
St Olavs Hospital	Trondheim	Norway

More St. Olavs Hospital trials in Denmark

Supramarginal Resection in Glioblastoma Active, not recruiting

The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery Recruiting

Other trials for the same condition

COMPuter-assisted Self-training to Improve EXecutive Function Recruiting

Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital Active, not recruiting

Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest Recruiting

Bicarbonate for In-Hospital Cardiac Arrest Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04596514 on ClinicalTrials.gov ↗ ← All trials in Denmark