Cardiac ArrestCPReboaNCT07434726
In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
A study testing resuscitative endovascular occlusion of the aorta (REBOA) and Advanced Cardiac Life Support (ACLS) in people with Cardiac Arrest, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- resuscitative endovascular occlusion of the aorta (REBOA) and Advanced Cardiac Life Support (ACLS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Apr 2026to Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from in hospital cardiac arrest (IHCA), including patients with out of hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC), transported to the emergency department, where they suffer a second arrest (IHCA)
- successful placement of a femoral artery introducer sheath
- any electrical cardiac activity seen in the initial rhythm analysis
- ongoing effort of resuscitation as determined by study-independent resuscitation lead
Who cannot join
- IHCA in the operating room, on intensive care unit or in the cardiac catheter laboratory
- hospital visitors suffering from cardiac arrest
- asystole seen in the initial rhythm analysis
- (presumed) age under 18 years
- known "do not resuscitate"-order
- known or obvious pregnancy
Show all 9Show fewer
- traumatic cardiac arrest
- known aortic pathologies that render cannulation impossible
- known allergies to radiographic contrast agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital University Hospital Bern
Bern, 3010
Tanja Birrenbach, MD, 41316325701, ukn.studynurse@insel.ch
Wolf E Hautz, MD
About this study
Official title: CPReboa: In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta.
Read the detailed description
Patients with in-hospital cardiac arrest (IHCA) outside the operating room, the coronary angiography suite and the intensive care unit (ICU) will be attended to by the hospitals resuscitation team and provided with advanced cardiac life support (ACLS) as per usual practice.
A research team will be deployed simultaneously and, when patients meet inclusion criteria, will randomize patients to ACLS alone or to ACLS plus balloon occlusion of the descending thoracic aorta by means of a resuscitative endovascular occlusion of the aorta (REBOA) catheter.
- Conditions
- Cardiac Arrest
- Being tested
- resuscitative endovascular occlusion of the aorta (REBOA), Advanced Cardiac Life Support (ACLS)
- Keywords
- Cardiac Arrest, resuscitative endovascular occlusion of the aorta REBOA, cardio pulmonary resuscitation CPR, advanced cardiac life support ACLS
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resuscitative endovascular occlusion of the aorta (REBOA)Device
Insertion of a balloon catheter through the common femoral artery, retrograde advancement of the catheter into the descending thoracic aorta, ballon occlusion of the aorta
Advanced Cardiac Life Support (ACLS)Other
Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards
| Study group | Role | What they receive |
|---|---|---|
| Advanced Cardiac Life Support (ACLS) alone | Active comparator | Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as extended cardio-pulmonary resuscitation (eCPR). Receives: Other: Advanced Cardiac Life Support (ACLS) |
| Advanced Cardiac Life Support (ACLS) plus REBOA | Experimental | Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as eCPR plus resuscitative balloon occlusion of the descending thoracic aorta (REBOA). Receives: Device: resuscitative endovascular occlusion of the aorta (REBOA); Other: Advanced Cardiac Life Support (ACLS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained ROSC
Any return of spontaneous circulation lasting longer then 20 minutes
Measured: Up to 1 hour after study inclusion
Secondary outcomes (6)
Survival to hospital discharge
dead or alive
Measured: at hospital discharge, up to 90 days after study inclusion
Survival to six month
dead or alive
Measured: 6 month after study inclusion
neurologic outcome at the time of 30 days
measured by means of modified ranking scale
Measured: Day 30 after study inclusion
neurologic outcome at the time of six month
measured by means of modified ranking scale
Measured: 6 month after study inclusion
ICU-free days before hospital discharge
Measured: at hospital discharge, up to 90 days after study inclusion
ICU-free days at 30 days
Measured: 30 days after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start14 Apr 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Insel Gruppe AG, University Hospital BernThe 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
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Birrenbach, MD, MME, Principal investigator, Inselspital University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434726
- Sponsor's protocol ID
- CPReboa
- Acronym
- CPReboa
- Status last verified
- Jul 2026
- First submitted
- 12 Feb 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IBD (including data dictionaries) will be shared upon reasonable request with researcher eligible health data under Swiss legislation. Eligibility will be determined by Cantonal Ethics Committee of Bern. This determination will require submission of a research plan to the ethics committee. Data will be provided as electronic files in STATA file format as exported from the RedCap study database. The trials study protocol is available on the trial website at http://cpreboa.org. The statistical analysis protocol will become available on the trial website an in the Zenodo registry before inclusion of the last patient into the trial.
Publications
Gaube LM, Sparks ED, Iten M, Knapp J, Furholz M, Schefold JC, Hunziker Munsch L, Hanggi M, Krummrey G, Muller M, Hautz WE. In-hospital cardiopulmonary resuscitation with balloon occlusion of the descending aorta: protocol of the randomised controlled CPReboa study. BMJ Open. 2026 Aug 11;16(8):e119691. doi: 10.1136/bmjopen-2026-119691.
PubMed 42580829
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPReboa: In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
- ClinicalTrials.gov ID
- NCT07434726
- Acronym / sponsor ID
- CPReboa / CPReboa
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, resuscitative endovascular occlusion of the aorta REBOA, cardio pulmonary resuscitation CPR, advanced cardiac life support ACLS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Feb 2026 (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.
This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta.
Detailed description
Patients with in-hospital cardiac arrest (IHCA) outside the operating room, the coronary angiography suite and the intensive care unit (ICU) will be attended to by the hospitals resuscitation team and provided with advanced cardiac life support (ACLS) as per usual practice.
A research team will be deployed simultaneously and, when patients meet inclusion criteria, will randomize patients to ACLS alone or to ACLS plus balloon occlusion of the descending thoracic aorta by means of a resuscitative endovascular occlusion of the aorta (REBOA) catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Cardiac Life Support (ACLS) alone | Active comparator | Other: Advanced Cardiac Life Support (ACLS)Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as extended cardio-pulmonary resuscitation (eCPR). |
| Advanced Cardiac Life Support (ACLS) plus REBOA | Experimental | Device: resuscitative endovascular occlusion of the aorta (REBOA), Other: Advanced Cardiac Life Support (ACLS)Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as eCPR plus resuscitative balloon occlusion of the descending thoracic aorta (REBOA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients suffering from in hospital cardiac arrest (IHCA), including patients with out of hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC), transported to the emergency department, where they suffer a second arrest (IHCA)
- successful placement of a femoral artery introducer sheath
- any electrical cardiac activity seen in the initial rhythm analysis
- ongoing effort of resuscitation as determined by study-independent resuscitation lead
Key exclusion criteria (9 listed)
- IHCA in the operating room, on intensive care unit or in the cardiac catheter laboratory
- hospital visitors suffering from cardiac arrest
- asystole seen in the initial rhythm analysis
- (presumed) age under 18 years
- known "do not resuscitate"-order
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 |
|---|---|---|
| resuscitative endovascular occlusion of the aorta (REBOA)Insertion of a balloon catheter through the common femoral artery, retrograde advancement of the catheter into the descending thoracic aorta, ballon occlusion of the aorta | Device | Advanced Cardiac Life Support (ACLS) plus REBOA |
| Advanced Cardiac Life Support (ACLS)Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards | Other | Advanced Cardiac Life Support (ACLS) alone, Advanced Cardiac Life Support (ACLS) plus REBOA |
Primary outcome
Sustained ROSC
Time frame: Up to 1 hour after study inclusion
Any return of spontaneous circulation lasting longer then 20 minutes
6 secondary outcomes
Survival to hospital discharge
Time frame: at hospital discharge, up to 90 days after study inclusion
Survival to six month
Time frame: 6 month after study inclusion
neurologic outcome at the time of 30 days
Time frame: Day 30 after study inclusion
neurologic outcome at the time of six month
Time frame: 6 month after study inclusion
ICU-free days before hospital discharge
Time frame: at hospital discharge, up to 90 days after study inclusion
ICU-free days at 30 days
Time frame: 30 days after study inclusion
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 21 Aug 2026.
- Derived from this study: PubMed 42580829Gaube LM, Sparks ED, Iten M, Knapp J, Furholz M, Schefold JC, Hunziker Munsch L, Hanggi M, Krummrey G, Muller M, Hautz WE. In-hospital cardiopulmonary resuscitation with balloon occlusion of the descending aorta: protocol of the randomised controlled CPReboa study. BMJ Open. 2026 Aug 11;16(8):e119691. doi: 10.1136/bmjopen-2026-119691.
- Individual participant dataSharing planned: Yes. All IBD (including data dictionaries) will be shared upon reasonable request with researcher eligible health data under Swiss legislation. Eligibility will be determined by Cantonal Ethics Committee of Bern. This determination will require submission of a research plan to the ethics committee. Data will be provided as electronic files in STATA file format as exported from the RedCap study database. The trials study protocol is available on the trial website at http://cpreboa.org. The statistical analysis protocol will become available on the trial website an in the Zenodo registry before inclusion of the last patient into the trial.
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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.
Tanja Birrenbach, MD, MME principal investigator
Inselspital University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resuscitative endovascular occlusion of the aorta (REBOA) and Advanced Cardiac Life Support (ACLS) in people with Cardiac Arrest, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 9 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Contact Tanja Birrenbach, MD, MME (+41 31 632 57 01, tanja.birrenbach@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained ROSC (time frame: Up to 1 hour after study inclusion). 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 NCT07434726, which also lists 1 linked publication.
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 21 Aug 2026.