Cardiac ArrestREBOARRESTNCT04596514
Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
A study testing REBOA and usual procedure according to guidelines in people with Cardiac Arrest, run by St. Olavs Hospital at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- REBOA and usual procedure according to guidelines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 7 Jun 2021to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Norway6 sites
Haukeland University Hospital
Bergen
Drammen Hospital
Drammen
Lørenskog HEMS Unit
Oslo
Rapid response car - 119 Oslo
Oslo
Stavanger University Hospital
Stavanger, 4068
St Olavs Hospital
Trondheim, 7030
Denmark4 sites
Aarhus Base
Aarhus
Billund HEMS-base
Billund
Ringsted HEMS-base
Ringsted
Skive HEMS
Skive
About this study
Official title: A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
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.
Read more
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.
Read the 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
- Being tested
- REBOA, usual procedure according to guidelines
- Keywords
- Reboa procedure, aortic occlusion, resuscitation, pre-hospital emergency care
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBOAProcedure or surgery
Resuscitative endovascular balloon occlusion of the aorta (REBOA)
usual procedure according to guidelinesProcedure or surgery
Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - REBOA | Experimental | Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved Receives: Procedure: REBOA; Procedure: usual procedure according to guidelines |
| Control group - ACLS | Active comparator | Advanced cardiovascular life support as described in the guidelines Receives: Procedure: usual procedure according to guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes.
Sustained ROSC means return of spontaneous circulation with a duration of at least 20 minutes.
Measured: 60 minutes
Secondary outcomes (4)
The proportion of patients surviving to 30 days with good neurologic status, defined as a modified Rankin scale (mRS) score 0-3.
The mRs are dichotomised into good (score 0-3) and poor (score 4-6) neurological state.
Measured: 30 days
Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion.
In the control group, EtCO2 is measured after airway management is completed. In the intervention group, EtCO2 is measured after airway management is completed, before balloon inflation and 30, 60 and 90 seconds after balloon inflation.
Measured: 15 minutes
Change in blood pressures after aortic occlusion
In the intervention group, intra-aortic blood pressure measurements from the REBOA catheter are recorded. This applies only to the catheters with CE/FDA approval for invasive blood pressure measurements and will therefore be assessed in a sub-group of the participants. Continuous registration of invasive blood pressure will start before aortic occlusion.
Measured: 15 minutes
Difference in left ventricular ejection fraction (LVEF) measured by echocardiography
Echocardiography after admission, after a few days-up to one week and at discharge will be assessed - both from the control and intervention group.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start7 Jun 2021
- Primary completion28 Jun 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation
- Responsible party
- Sponsor
- Investigators
- Rune Wiseth, MD, PhD, Study director, St Olav&amp;#39;s Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596514
- Sponsor's protocol ID
- U1111-1253-0322
- Other IDs
- U1111-1253-0322
- Acronym
- REBOARREST
- Status last verified
- Jul 2026
- First submitted
- 12 Oct 2020
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol, statistical analysis plan, information letter for consent and other trial documents will be published open access. The clinical study report and statistical analysis report will also be made openly available but may be altered to hide information that may lead to identification of individual study participants. These documents will be shared at HUNT Cloud.
Publications
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.
PubMed 31707942Brede JR, Farbu BH, Gamberini L, Thorsen K, Rehn M, Rognas L, Tonsager K, Sunde GA, Lauritzen M, Lupi C, Tartaglione M, Skjaerseth EA, Aaen M, Wiseth R, Kruger AJ. Prehospital resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest (REBOARREST): an international, multicentre, open label, pragmatic, randomised, controlled trial. Crit Care. 2026 May 5;30(1):324. doi: 10.1186/s13054-026-06057-y.
PubMed 42087223Brede 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.
PubMed 34332617
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04596514
- Acronym / sponsor ID
- REBOARREST / U1111-1253-0322
- Conditions
- Cardiac Arrest
- Keywords
- Reboa procedure, aortic occlusion, resuscitation, pre-hospital emergency care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - REBOA | Experimental | Procedure: REBOA, Procedure: usual procedure according to guidelinesResuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved |
| Control group - ACLS | Active comparator | Procedure: usual procedure according to guidelinesAdvanced cardiovascular life support as described in the guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REBOAResuscitative endovascular balloon occlusion of the aorta (REBOA) | Procedure or surgery | Intervention group - REBOA |
| usual procedure according to guidelinesTreatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines | Procedure or surgery | Control group - ACLS, Intervention group - REBOA |
Primary outcome
Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes.
Time frame: 60 minutes
Sustained ROSC means return of spontaneous circulation with a duration of at least 20 minutes.
4 secondary outcomes
The proportion of patients surviving to 30 days with good neurologic status, defined as a modified Rankin scale (mRS) score 0-3.
Time frame: 30 days
Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion.
Time frame: 15 minutes
Change in blood pressures after aortic occlusion
Time frame: 15 minutes
Difference in left ventricular ejection fraction (LVEF) measured by echocardiography
Time frame: 1-2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 31707942Brede 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.
- Derived from this study: PubMed 42087223Brede JR, Farbu BH, Gamberini L, Thorsen K, Rehn M, Rognas L, Tonsager K, Sunde GA, Lauritzen M, Lupi C, Tartaglione M, Skjaerseth EA, Aaen M, Wiseth R, Kruger AJ. Prehospital resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest (REBOARREST): an international, multicentre, open label, pragmatic, randomised, controlled trial. Crit Care. 2026 May 5;30(1):324. doi: 10.1186/s13054-026-06057-y.
- Derived from this study: PubMed 34332617Brede 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.
- Individual participant dataSharing planned: Yes. The full study protocol, statistical analysis plan, information letter for consent and other trial documents will be published open access. The clinical study report and statistical analysis report will also be made openly available but may be altered to hide information that may lead to identification of individual study participants. These documents will be shared at HUNT Cloud.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune Wiseth, MD, PhD study director
St Olav&amp;#39;s Hospital
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REBOA and usual procedure according to guidelines in people with Cardiac Arrest, run by St. Olavs Hospital at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Norway, Denmark, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes. (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596514, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.