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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Procedure: REBOA
* Procedure: usual procedure according to guidelines


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group - REBOA<br>Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved | Procedure: REBOA<br>* Resuscitative endovascular balloon occlusion of the aorta (REBOA)<br>Procedure: usual procedure according to guidelines<br>* Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines<br>|
| Active Comparator: Control group - ACLS<br>Advanced cardiovascular life support as described in the guidelines | Procedure: usual procedure according to guidelines<br>* Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes. | Sustained ROSC means return of spontaneous circulation with a duration of at least 20 minutes. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients surviving to 30 days with good neurologic status, defined as a modified Rankin scale (mRS) score 0-3. | The mRs are dichotomised into good (score 0-3) and poor (score 4-6) neurological state. | 30 days | 
| Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion. | In the control group, EtCO2 is measured after airway management is completed. In the intervention group, EtCO2 is measured after airway management is completed, before balloon inflation and 30, 60 and 90 seconds after balloon inflation. | 15 minutes | 
| Change in blood pressures after aortic occlusion | In the intervention group, intra-aortic blood pressure measurements from the REBOA catheter are recorded. This applies only to the catheters with CE/FDA approval for invasive blood pressure measurements and will therefore be assessed in a sub-group of the participants. Continuous registration of invasive blood pressure will start before aortic occlusion. | 15 minutes | 
| Difference in left ventricular ejection fraction (LVEF) measured by echocardiography | Echocardiography after admission, after a few days-up to one week and at discharge will be assessed - both from the control and intervention group. | 1-2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reboa procedure, aortic occlusion, resuscitation, pre-hospital emergency care