Feasibility of REBOA in Refractory Cardiac Arrest

NCT03664557 | Completed DMC

• 1 other identifier: ReaReboa
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Arrest

Keywords

Resuscitation; REBOA

Outcome Measures

Primary Outcomes (1)

• Percentage of successful placements

  Percentage of successful placements within 10 minutes from start of the investigated procedure (start defined as end of skin disinfection) to balloon inflation

  10 minutes

Secondary Outcomes (3)

• Number of attempts

  60 min

• Time of the successful attempt

  60 min

• Overall time

  60 min

Study Arms (1)

ER Reboa TM Catheter

EXPERIMENTAL

During cardiac arrest occlusion of descending aorta to redistribute CPR-generated blood flow to brain and coronaries

Device: ER Reboa TM Catheter

Interventions

ER Reboa TM Catheter DEVICE

During cardiac arrest occlusion of descending aorta to redistribute CPR-generated blood flow to brain and coronaries

ER Reboa TM Catheter

Eligibility Criteria

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

You may qualify if:

• 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).

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)
• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Departement of Intensive Care Medicine - University Hospital Bern - Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Anja Levis, MD

  Dep of Intensive Care Medicine, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open label feasibility study

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 10, 2018
• Study Start: November 26, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

CH (1)