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.
BACKGROUND
Survival after out-of-hospital cardiac arrest (OHCA) is poor and dependent on high-quality cardiopulmonary resuscitation. Resuscitative endovascular balloon occlusion of the aorta (REBOA) may be advantageous in non-traumatic OHCA due to the potential benefit of redistributing the cardiac output to organs proximal to the aortic occlusion. This theory is supported by data from both preclinical studies and human case reports.


METHODS
This multicentre trial will enrol 200 adult patients, who will be randomised in a 1:1 ratio to either a control group that receives advanced cardiovascular life support (ACLS) or an intervention group that receives ACLS and REBOA. The primary endpoint will be the proportion of patients who achieve return of spontaneous circulation with a duration of at least 20 min. The secondary objectives of this trial are to measure the proportion of patients surviving to 30 days with good neurological status, to describe the haemodynamic physiology of aortic occlusion during ACLS, and to document adverse events.


DISCUSSION
Results from this study will assess the efficacy and safety of REBOA as an adjunctive treatment for non-traumatic OHCA. This novel use of REBOA may contribute to improve treatment for this patient cohort.


TRIAL REGISTRATION
The trial is approved by the Regional Committee for Medical and Health Research Ethics in Norway (reference 152504) and is registered at ClinicalTrials.gov (reference NCT04596514) and as Universal Trial Number WHO: U1111-1253-0322.
['Brede|Jostein Rødseth|JR|http://orcid.org/0000-0001-9497-1147', 'Skulberg|Arne Kristian|AK|', 'Rehn|Marius|M|', 'Thorsen|Kjetil|K|', 'Klepstad|Pål|P|', 'Tylleskär|Ida|I|', 'Farbu|Bjørn|B|', 'Dale|Jostein|J|', 'Nordseth|Trond|T|', 'Wiseth|Rune|R|', 'Krüger|Andreas Jørstad|AJ|']
D000328:Adult D001011:Aorta D021721:Balloon Occlusion D016887:Cardiopulmonary Resuscitation D057510:Endovascular Procedures D006801:Humans D015337:Multicenter Studies as Topic D009664:Norway D058687:Out-of-Hospital Cardiac Arrest D016032:Randomized Controlled Trials as Topic D012151:Resuscitation D012771:Shock, Hemorrhagic
Cardiac arrest Resuscitative endovascular balloon occlusion of the aorta (REBOA) Aortic occlusion Advanced cardiopulmonary resuscitation (ACLS) Cardiopulmonary resuscitation (CPR) Return of spontaneous circulation (ROSC)