NCT03664557

Feasibility of REBOA in Refractory Cardiac Arrest

Completed NA Last updated 3 November 2020

What this trial tests

NA trial testing ER Reboa TM Catheter in Heart Arrest in 15 participants. Completed in 19 December 2019.

Timeline

26 November 2018

Primary endpoint
19 December 2019

19 December 2019

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	15
Start date	26 November 2018
Primary completion	19 December 2019
Estimated completion	19 December 2019
Sites	1 location across Switzerland

Drugs / interventions tested

• ER Reboa TM Catheter

Conditions studied

• Heart Arrest — all drugs for Heart Arrest →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Heart Arrest. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA): update and insights into current practices and future directions for research and implementation.
   Thrailkill MA, Gladin KH, Thorpe CR, Roberts TR, et al · · 2021 · cited 27× · PMID 33407759 · DOI 10.1186/s13049-020-00807-9