NCT04596514

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomised, parallel group, multi-centre, phase II clinical trial. Patients are randomised in a 1:1 ratio to be included to the control group or the intervention group. The control group receives ACLS according to national guidelines, while the intervention group receives ACLS according to national guidelines and the REBOA procedure as an adjunct treatment. The REBOA procedure is performed by a team consisting of a physician (anesteshiologist) and a paramedic, working at a helicopter emergency medical service (HEMS) base. All operators will be properly educated and tested before they can include patients. If the patients in the intervention group achieves ROSC, the balloon will be deflated and post-ROSC treatment will be continued as per routine.

Conditions

• Cardiac Arrest

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-07
• Primary completion: 2025-06-28
• Completion: 2026-07-01
• First posted: 2020-10-22
• Last updated: 2025-07-08

Locations

11 sites across 3 countries: Denmark, Italy, Norway