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Feasibility of REBOA in Refractory Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT03664557
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
Outcome after non-traumatic cardiac arrest remains poor despite many efforts in improving immediate advanced life support (ALS) and post-arrest therapy. Preserving myocardial and cerebral perfusion in the event of cardiac arrest by the means of effective cardio-pulmonary resuscitation (CPR) is of utmost importance. 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. The absence of ROSC despite prolonged high quality and efficient initial basic life support (BLS) followed by traditional ALS ends finally in neuronal damage and death. Occlusion of the aorta using a REBOA catheter in the management of noncompressible 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. 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. These promising data provide an opportunity to improve outcome after cardiac arrest in humans too. Before testing such an approach in humans, the safe and reliable placement procedure of the catheter-balloon in humans after cardiac arrest needs to be established under ongoing CPR.

Condition or disease Intervention/treatment Phase
Heart Arrest Device: ER Reboa TM Catheter Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label feasibility study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Patients Suffering From Refractory Cardiac Arrest: a Pilot Study
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: ER Reboa TM Catheter
During cardiac arrest occlusion of descending aorta to redistribute CPR-generated blood flow to brain and coronaries
Device: ER Reboa TM Catheter
During cardiac arrest occlusion of descending aorta to redistribute CPR-generated blood flow to brain and coronaries




Primary Outcome Measures :
  1. Percentage of successful placements [ Time Frame: 10 minutes ]
    Percentage of successful placements within 10 minutes from start of the investigated procedure (start defined as end of skin disinfection) to balloon inflation


Secondary Outcome Measures :
  1. Number of attempts [ Time Frame: 60 min ]
    Number of attempts (both vessel puncture and placement of catheter),

  2. Time of the successful attempt [ Time Frame: 60 min ]
    Time of the successful attempt (from successful arterial puncture to balloon inflation),

  3. Overall time [ Time Frame: 60 min ]
    Overall time (from start to inflation)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in the resuscitation bay, intensive care unit or coronary angiography laboratory with refractory cardiac arrest, defined as failure to achieve stable ROSC within 10 min of fully established standard care (ALS), who do not qualify for extracorporeal cardiac life support (e-CPR).

Exclusion Criteria:

  • 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)
    • 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 of thoracic hemorrhage (eFAST)
    • Study personnel and/or study equipment not available at the time of study inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664557


Contacts
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Contact: Matthias Haenggi, MD +41 31 362 3029 matthias.haenggi@insel.ch
Contact: Anja Levis, MD anja.levis@insel.ch

Locations
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Switzerland
Departement of Intensive Care Medicine - University Hospital Bern - Inselspital Recruiting
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Anja Levis, MD Dep of Intensive Care Medicine, University Hospital Bern

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03664557     History of Changes
Other Study ID Numbers: ReaReboa
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: individual decision upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Inselspital, Berne:
Resuscitation
REBOA

Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases