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

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: Recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Advanced Cardiac Life Support (ACLS); Device: resuscitative endovascular occlusion of the aorta (REBOA)

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: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wolf E Hautz, MD, MME; Phone Number: +41 31 632 57 01; Email: wolf.hautz@insel.ch
• Study Contact Backup: Name: Cornelia Lammbrigger, RN; Phone Number: +41 31 632 57 01; Email: ukn.studynurse@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • InselSpital University Hospital Bern
    • Contact: Wolf E Hautz, MD; Phone Number: 41316325701; Email: ukn.studynurse@insel.ch

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Sustained ROSC	Any return of spontaneous circulation lasting longer then 20 minutes	Up to 1 hour after study inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival to hospital discharge	dead or alive	at hospital discharge, up to 90 days after study inclusion
Survival to six month	dead or alive	6 month after study inclusion
neurologic outcome at the time of 30 days	measured by means of modified ranking scale	Day 30 after study inclusion
neurologic outcome at the time of six month	measured by means of modified ranking scale	6 month after study inclusion
ICU-free days before hospital discharge		at hospital discharge, up to 90 days after study inclusion
ICU-free days at 30 days		30 days after study inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-invasive cerebral oxygenation during resuscitation	Exploratory, measured in %	Continuously assessed during ongoing resuscitation, up to 1 hour after study inclusion
cause of death	exploratory, written description	at six month
Troponin T trajectory	exploratory	at inclusion, 30 minutes after inclusion and once up to day 3
Neuron-Specific Enolase (NSE) trajectory	exploratory	at inclusion, 30 minutes after inclusion and once up to day 3

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Wolf E Hautz, MD, MME, InselSpital University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Arrest; resuscitative endovascular occlusion of the aorta REBOA; cardio pulmonary resuscitation CPR; advanced cardiac life support ACLS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Resuscitation; Emergency Treatment; Cardiopulmonary Resuscitation; Life Support Care; Advanced Cardiac Life Support
• Other Study ID Numbers: CPReboa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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