REBOA in Out-of-hospital Cardiac Arrest

NCT04373122 | Unknown DMC

• 1 other identifier: 2019-02039
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Unexpected cardiac arrest is a frequent and devastating event with a high mortality and morbidity. Half of the patients who survive to ICU admission ultimately die because of hypoxic-ischemic encephalopathy. With CPR and advanced life support, blood and oxygen delivery to heart and brain is preserved until circulation is restored. During CPR, coronary perfusion pressure is a significant predictor of increased rates of return of spontaneous circulation (ROSC) and survival to hospital discharge, while cerebral perfusion pressure is crucial for good neurologic outcome. Existing efforts to reduce mortality and morbidity focus on rapid recognition of cardiac arrest, initiation of basic and advanced life support (ALS), and optimization of post-arrest care. Clamping the descending aorta during cardio-pulmonary resuscitation (CPR) should redistribute the blood flow towards brain and heart. Animal models of continuous balloon occlusion of the aorta in non-traumatic cardiac arrest have shown meaningful increases in coronary artery blood flow, coronary artery perfusion pressure and carotid blood flow, leading to improved rates of ROSC, 48h-survival and neurological function. In humans, occlusion of the aorta using a REBOA catheter in the management of non-compressible abdominal or pelvic hemorrhage has shown improvements in hemodynamic profiles and has proved to be feasible in both, clinical and preclinical settings for trauma patients in hemorrhagic shock. These promising data provide an opportunity to improve outcome after cardiac arrest in humans too. The investigators have developed a protocol for the reliable and safe placement of a REBOA-catheter during cardiac arrest in a clinical setting (see ClinicalTrials.gov Identifier: NCT03664557). Damage to heart and brain from lack of oxygen supply occurs during the first minutes following cardiac arrest. It is therefore crucial to apply any measure to improve efficacy of CPR early in the course of events and therapy. After proving feasibility in a clinical setting in the trial mentioned above, the next logical step and specific goal of this study is to transfer this protocol to the preclinical setting, and to investigate the effect of temporary endovascular occlusion of the descending aorta on the efficacy of CPR early in the course of treatment of out-of hospital cardiac arrest by means of an increase in blood pressure.

Conditions

Out-of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Change of blood pressure

  Increase of blood pressure after balloon occlusion of the aorta

  10 minutes

Secondary Outcomes (2)

• Change of NIRS

  10 minutes

• Change of etCO2

  10 minutes

Other Outcomes (1)

• Outcomes

  up to 6 months

Study Arms (1)

REBOA

EXPERIMENTAL

Insertion of the ER-REBOA Catheter during ongoing CPR

Device: REBOA

Interventions

REBOA DEVICE

Resuscitative Endovascular Balloon Occlusion of the Aorta

REBOA

Eligibility Criteria

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

You may qualify if:

• Patients suffering from refractory Out-of-hospital cardiac arrest (OHCA) of presumed cardiac origin, defined as failure to achieve stable ROSC within 10 min of fully established standard care (ALS) which do not qualify for extracorporeal cardiac life support (e-CPR).
• Witnessed Arrest
• Interval from collapse to initiation of sufficient (lay) CPR less than 5 minutes

You may not qualify if:

• Patients whose underlying disease limit survival and resuscitation measures are stopped after initial assessment, or evaluation reveals futile clinical situation
• Patients with advanced directives or living will which excludes CPR
• Age \< 18 years (device certified \>18 years)
• Qualifying for other treatment options, namely eCPR (CPR with extracorporeal membrane oxygenation (ECMO) as life assist device)
• Unwitnessed arrest with asystole as first documented rhythm
• etCO2 below 15mmHg
• Patients in whom no femoral arterial access site cannot accommodate a 7 Fr (minimum) introducer sheath
• Known to have an aortic diameter larger than 32 mm
• Evidence or suspicion of thoracic trauma
• Inability to guarantee standard ALS measures during performance of the REBOA maneuver

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• City of Bern: collaborator

Study Sites (1)

Departement of Intensive Care Medicine - University Hospital Bern - Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Anja Levis, MD

  University of Bern, Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Levis, MD

CONTACT

+41316327855; Anja.Levis@insel.ch

Matthias Haenggi, MD

CONTACT

+41316323029; Matthias.Haenggi@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start: June 7, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)