Advanced Reperfusion Strategies for Refractory Cardiac Arrest

Study Overview
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Brief Summary
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This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation

Official Title
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Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)

Conditions
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Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication, Ventricular Fibrillation, Pulseless Ventricular Tachycardia, Out-Of-Hospital Cardiac Arrest

Intervention / Treatment
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* Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation
* Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (presumed or known to be aged 18-75 years, inclusive), An initial documented OHCA rhythm of VF/VT, No ROSC following 3 defibrillation shocks, Body morphology able to accommodate a Lund University Cardiac Arrest System (LUCAS™) automated CPR device, and Estimated transfer time from the scene to the ED or CCL of < 30 minutes. Exclusion Criteria: Age < 18 years old or > 75 years old; Non-shockable initial OHCA rhythm (pulseless electrical activity [PEA] or asystole); Valid do-not-attempt-resuscitation orders (DNAR); Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose; Known prisoners; Known pregnancy; Nursing home residents; Unavailability of the cardiac catheterization laboratory. Severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure; Absolute contraindications to emergent coronary angiography including known anaphylactic reaction to angiographic contrast media and/or active gastrointestinal or internal bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: ECMO Facilitated Resuscitation<br>Regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, patients will enter the Cardiac Catheterization Laboratory (CCL) for expeditious VAECMO initiation, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate. | Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation<br>* Early use of ECMO<br>|
| Other: Standard ACLS Resuscitation<br>Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI, and potential VA ECMO or other circulatory support device initiation, as clinically indicated. | Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation<br>* Standard life support resuscitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Number of participants who survived to hospital discharge | Approximately 25 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) Score | mRS scale ranges from 0 (no residual symptoms) to 6 (dead). Scores of 3 (the patient has moderate disability), 2 (the patient has slight disability), 1 (the patient has no significant disability), and 0 indicate favorable outcome. Higher scores on the scale indicate more severe disability. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following. | At hospital discharge (average of 25 days), 3 months, 6 months | 
| Cerebral Performance Categories (CPC) Scale | CPC scale ranges from 1 (good cerebral performance) to 5 (brain death). CPC scores of 2 (moderate cerebral disability) and 1 indicate functional status. Higher scores on the scale indicate worse cerebral performance. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following. | At hospital discharge (average of 25 days), 3 months, 6 months | 
| Treatment Cost | Outcome is reported as the mean treatment cost in dollars. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced reperfusion, mechanical cardiopulmonary resuscitation