In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta (CPReboa)

August 20, 2026 updated by: Insel Gruppe AG, University Hospital Bern

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital University Hospital Bern
        • Contact:
        • Sub-Investigator:
          • Wolf E Hautz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • traumatic cardiac arrest
  • known aortic pathologies that render cannulation impossible
  • known allergies to radiographic contrast agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Advanced Cardiac Life Support (ACLS) alone
Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as extended cardio-pulmonary resuscitation (eCPR).
Other: Advanced Cardiac Life Support (ACLS)
Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards
Experimental: Advanced Cardiac Life Support (ACLS) plus REBOA
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).
Other: Advanced Cardiac Life Support (ACLS)
Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards
Device: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sustained ROSC
Time Frame: Up to 1 hour after study inclusion
Any return of spontaneous circulation lasting longer then 20 minutes
Up to 1 hour after study inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival to hospital discharge
Time Frame: at hospital discharge, up to 90 days after study inclusion
dead or alive
at hospital discharge, up to 90 days after study inclusion
Survival to six month
Time Frame: 6 month after study inclusion
dead or alive
6 month after study inclusion
neurologic outcome at the time of 30 days
Time Frame: Day 30 after study inclusion
measured by means of modified ranking scale
Day 30 after study inclusion
neurologic outcome at the time of six month
Time Frame: 6 month after study inclusion
measured by means of modified ranking scale
6 month after study inclusion
ICU-free days before hospital discharge
Time Frame: at hospital discharge, up to 90 days after study inclusion
at hospital discharge, up to 90 days after study inclusion
ICU-free days at 30 days
Time Frame: 30 days after study inclusion
30 days after study inclusion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
non-invasive cerebral oxygenation during resuscitation
Time Frame: Continuously assessed during ongoing resuscitation, up to 1 hour after study inclusion
Exploratory, measured in %
Continuously assessed during ongoing resuscitation, up to 1 hour after study inclusion
cause of death
Time Frame: at six month
exploratory, written description
at six month
Troponin T trajectory
Time Frame: at inclusion, 30 minutes after inclusion and once up to day 3
exploratory
at inclusion, 30 minutes after inclusion and once up to day 3
Neuron-Specific Enolase (NSE) trajectory
Time Frame: at inclusion, 30 minutes after inclusion and once up to day 3
exploratory
at inclusion, 30 minutes after inclusion and once up to day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tanja Birrenbach, MD, MME, Inselspital University Hospital Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPReboa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publication of the trial results. Data will remain available for five years.

IPD Sharing Access Criteria

Upon reasonable request to researcher eligible to work with coded individual biological, non-genetic health data under Swiss legislation - see above.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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