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RecruitingNCT07434726CPReboaUpdated Aug 21, 2026

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

An interventional study of resuscitative endovascular occlusion of the aorta (REBOA) and Advanced Cardiac Life Support (ACLS) in Cardiac Arrest, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Cardiac Arrest

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Keywords

  • Cardiac Arrest
  • resuscitative endovascular occlusion of the aorta REBOA
  • cardio pulmonary resuscitation CPR
  • advanced cardiac life support ACLS
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In context

Heart Arrest

965 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.

This study's planned enrollment of 98 is close to the median of 100 across 557 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
98 participants (estimated)

Study arms

  • 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)

  • 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).

    Device: resuscitative endovascular occlusion of the aorta (REBOA) · Other: Advanced Cardiac Life Support (ACLS)

Interventions

  • Deviceresuscitative 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

  • OtherAdvanced Cardiac Life Support (ACLS)

    Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards

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What researchers measure

Primary outcomes

  1. Sustained ROSC

    Any return of spontaneous circulation lasting longer then 20 minutes

    Time frame: Up to 1 hour after study inclusion

Secondary outcomes

  1. Survival to hospital discharge

    dead or alive

    Time frame: at hospital discharge, up to 90 days after study inclusion

  2. Survival to six month

    dead or alive

    Time frame: 6 month after study inclusion

  3. neurologic outcome at the time of 30 days

    measured by means of modified ranking scale

    Time frame: Day 30 after study inclusion

  4. neurologic outcome at the time of six month

    measured by means of modified ranking scale

    Time frame: 6 month after study inclusion

  5. ICU-free days before hospital discharge

    Time frame: at hospital discharge, up to 90 days after study inclusion

  6. ICU-free days at 30 days

    Time frame: 30 days after study inclusion

Other outcomes

  1. non-invasive cerebral oxygenation during resuscitation

    Exploratory, measured in %

    Time frame: Continuously assessed during ongoing resuscitation, up to 1 hour after study inclusion

  2. cause of death

    exploratory, written description

    Time frame: at six month

  3. Troponin T trajectory

    exploratory

    Time frame: at inclusion, 30 minutes after inclusion and once up to day 3

  4. Neuron-Specific Enolase (NSE) trajectory

    exploratory

    Time frame: at inclusion, 30 minutes after inclusion and once up to day 3

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Study locations

1 of 1 sites recruiting
  • Inselspital University Hospital Bern
    Bern, 3010, Switzerland
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07434726
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Apr 14, 2026
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Aug 21, 2026

Study contacts

Tanja Birrenbach, MD, MME
Contact
tanja.birrenbach@insel.ch
+41 31 632 57 01
Cornelia Lammbrigger, RN
Contact
ukn.studynurse@insel.ch
+41 31 632 57 01
Tanja Birrenbach, MD, MME
principal investigator · Inselspital University Hospital Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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