Clinical trial NCT04596514: Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
Official title: A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Keywords: Reboa procedure
aortic occlusion
resuscitation
pre-hospital emergency care
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Air Ambulance Foundation
First posted: 2020-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this trial is to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct treatment to advanced cardiovascular life support (ACLS) in patients with out-of-hospital cardiac arrest.

Out of hospital cardiac arrest (OHCA) carries a high mortality rate. The treatment of out-of-hospital cardiac arrest is ACLS as stated in the guidelines from the Norwegian Resuscitation Council and the European Resuscitation Guidelines.

Recently, REBOA has been proposed as an adjunct treatment in management of non-traumatic cardiac arrest patients, because thoracic aortic occlusion provides a redistribution of the cardiac output to organs proximal to the occlusion. Preclinical studies demonstrate that REBOA during CPR provide both increased coronary artery blood flow and perfusion pressure and increased rates of return of spontaneous circulation (ROSC).

This is the first prospective trial in the world to assess the efficacy of REBOA in non-traumatic cardiac arrest. The intervention is shown feasible in the pre-hospital setting. If this trial provides a signal of benefit in patients, this study could initiate further clinical research which could change current resuscitation practice world-wide.

Detailed description: This is a prospective, randomised, parallel group, multi-centre, phase II clinical trial.

Patients are randomised in a 1:1 ratio to be included to the control group or the intervention group. The control group receives ACLS according to national guidelines, while the intervention group receives ACLS according to national guidelines and the REBOA procedure as an adjunct treatment.

The REBOA procedure is performed by a team consisting of a physician (anesteshiologist) and a paramedic, working at a helicopter emergency medical service (HEMS) base. All operators will be properly educated and tested before they can include patients.

If the patients in the intervention group achieves ROSC, the balloon will be deflated and post-ROSC treatment will be continued as per routine.

Eligibility criteria: Inclusion Criteria:

* out-of-hospital cardiac arrest
* non-traumatic cardiac arrest
* less than 10 minutes from debut of arrest to start of basic or advanced cardiac life support
* advanced cardiac life support is established and can be continued

Exclusion Criteria:

* traumatic cardiac arrest, including strangulation, electrocution and patients rescued from avalanches
* accidental hypothermia with temperature \< 32 0C
* suspected cerebral hemorrhage as etiology of the arrest
* suspected non-traumatic hemorrhage as etiology of the arrest
* pregnancy, obvious or suspected
* patient included to the study site's E-CPR protocol
* other factors as decided by the treatment team (environmental factors, safety factors and others)

Primary outcomes:
measure: Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes.
timeFrame: 60 minutes
Secondary outcomes:
measure: The proportion of patients surviving to 30 days with good neurologic status, defined as a modified Rankin scale (mRS) score 0-3.
timeFrame: 30 days
measure: Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion.
timeFrame: 15 minutes
measure: Change in blood pressures after aortic occlusion
timeFrame: 15 minutes
measure: Difference in left ventricular ejection fraction (LVEF) measured by echocardiography
timeFrame: 1-2 weeks
Other outcomes:
measure: Exploratory outcome - All-cause mortality one year after randomization
timeFrame: One year
measure: Exploratory outcome - Difference in renal function between intervention and control group
timeFrame: 30 days
measure: Exploratory outcome - difference in the need for renal replacement therapy between intervention and control group
timeFrame: 30 days
measure: Exploratory outcome - difference in the liver function (albumine) between intervention and control group
timeFrame: 30 days
measure: Exploratory outcome - difference in the liver function (ASAT/ALAT) between intervention and control group
timeFrame: 30 days
measure: Exploratory outcome - Incidents of all adverse events
timeFrame: 30 days
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Base
city: Billund
country: Denmark
facility: Billund HEMS-base
city: Ringsted
country: Denmark
facility: Ringsted HEMS-base
city: Skive
country: Denmark
facility: Skive HEMS
city: Bologna
country: Italy
facility: Maggiore Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Drammen Hospital
city: Oslo
country: Norway
facility: Lørenskog HEMS Unit
city: Oslo
country: Norway
facility: Rapid response car - 119 Oslo
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St Olav&amp;amp;#39;s Hospital
name: Rune Wiseth, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11.
citation: Brede JR, Skulberg AK, Rehn M, Thorsen K, Klepstad P, Tylleskar I, Farbu B, Dale J, Nordseth T, Wiseth R, Kruger AJ. 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. Trials. 2021 Jul 31;22(1):511. doi: 10.1186/s13063-021-05477-1.