Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest (REBOARREST)

St. Olavs Hospital

Status: Active, not recruiting

Conditions: Cardiac Arrest

Treatments: Procedure: REBOA; Procedure: usual procedure according to guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT04596514

U1111-1253-0322 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Intervention group - REBOA

Experimental group

Description:

Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved

Treatment:

Procedure: usual procedure according to guidelines

Procedure: REBOA

Control group - ACLS

Active Comparator group

Description:

Advanced cardiovascular life support as described in the guidelines

Treatment:

Procedure: usual procedure according to guidelines