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

NCT04596514 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-08

No results posted yet for this 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.

Conditions

  • Cardiac Arrest

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

Sponsors & Collaborators

  • Norwegian Air Ambulance Foundation

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Rune Wiseth, MD, PhD · St Olav's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2025-06-28
Completion
2026-07-31

Countries

  • Denmark
  • Italy
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04596514 on ClinicalTrials.gov