Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

NCT04596514 | Active Not Recruiting DMC

• 1 other identifier: U1111-1253-0322
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 11

Brief 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. 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.

Conditions

Cardiac Arrest

Keywords

Reboa procedure; aortic occlusion; resuscitation; pre-hospital emergency care

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  30 days

• Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion.

  15 minutes

• Change in blood pressures after aortic occlusion

  15 minutes

• Difference in left ventricular ejection fraction (LVEF) measured by echocardiography

  1-2 weeks

Other Outcomes (6)

• Exploratory outcome - All-cause mortality one year after randomization

  One year

• Exploratory outcome - Difference in renal function between intervention and control group

  30 days

• Exploratory outcome - difference in the need for renal replacement therapy between intervention and control group

  30 days

Study Arms (2)

Intervention group - REBOA

EXPERIMENTAL

Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved

Procedure: REBOA; Procedure: usual procedure according to guidelines

Control group - ACLS

ACTIVE COMPARATOR

Advanced cardiovascular life support as described in the guidelines

Procedure: usual procedure according to guidelines

Interventions

REBOA PROCEDURE

Resuscitative endovascular balloon occlusion of the aorta (REBOA)

Intervention group - REBOA

usual procedure according to guidelines PROCEDURE

Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines

Control group - ACLS; Intervention group - REBOA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian Air Ambulance Foundation: collaborator

Study Sites (11)

Aarhus Base

Aarhus, Denmark

Location

Billund HEMS-base

Billund, Denmark

Location

Ringsted HEMS-base

Ringsted, Denmark

Location

Skive HEMS

Skive, Denmark

Location

Maggiore Hospital

Bologna, Italy

Location

Haukeland University Hospital

Bergen, Norway

Location

Drammen Hospital

Drammen, Norway

Location

Lørenskog HEMS Unit

Oslo, Norway

Location

Rapid response car - 119 Oslo

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, 4068, Norway

Location

St Olavs Hospital

Trondheim, 7030, Norway

Location

Related Publications (2)

• 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.

  PMID: 31707942 BACKGROUND

• Brede 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.

  PMID: 34332617 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rune Wiseth, MD, PhD

  St Olav&amp;amp;#39;s Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded from the statisticians who carry out analyses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 22, 2020
• Study Start: June 7, 2021
• Primary Completion: June 28, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study protocol and ICF will be available before study start. SAP will be available before first interim analysis.
• Access Criteria: Individual level data will be made available to sponsor institutions on the REBOARREST data space in HUNT Cloud. Access will be controlled by a data processor agreement between the partner and funder. Pseudonymous individual level data collected during the trial, will be made available on request to researchers from other scientific institutions by approval of the project management to ensure that usage is compliant with privacy and consent requirements as well as conditions for attribution and usage. Data sharing with editors or peer-reviewers of scientific journals, conferences or the like will not require additional consent or data access agreement with sponsor, as such data will not be shared onward or used beyond reviewing this trial. After data sharing, the sponsor must be acknowledged in any publication resulting from the shared data. For closer collaboration attribution based on the Vancouver Convention will apply.

Locations

IT (1); DK (4); NO (6)