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ACTIVE NOT RECRUITING
NCT04596514
NA

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

Sponsor: St. Olavs Hospital

View on ClinicalTrials.gov

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.

Official title: A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2021-06-07

Completion Date

2026-07

Last Updated

2025-07-08

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

REBOA

Resuscitative endovascular balloon occlusion of the aorta (REBOA)

PROCEDURE

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

Locations (11)

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