Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
NCT ID: NCT04596514
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2021-06-07
2026-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group - REBOA
Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved
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
Control group - ACLS
Advanced cardiovascular life support as described in the guidelines
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Norwegian Air Ambulance Foundation
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Rune Wiseth, MD, PhD
Role: STUDY_DIRECTOR
St Olav&amp;#39;s Hospital
Locations
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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
Countries
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References
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Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11.
Brede JR, Skulberg AK, Rehn M, Thorsen K, Klepstad P, Tylleskar I, Farbu B, Dale J, Nordseth T, Wiseth R, Kruger AJ. REBOARREST, resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest: a study protocol for a randomised, parallel group, clinical multicentre trial. Trials. 2021 Jul 31;22(1):511. doi: 10.1186/s13063-021-05477-1.
Other Identifiers
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U1111-1253-0322
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1253-0322
Identifier Type: -
Identifier Source: org_study_id
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