Advanced Reperfusion Strategies for Refractory Cardiac Arrest

University of Minnesota30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cardiac Arrest Extracorporeal Membrane Oxygenation Complication Ventricular Fibrillation Pulseless Ventricular Tachycardia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Survival

Number of participants who survived to hospital discharge

Time frame: Approximately 25 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: At hospital discharge (average of 25 days), 3 months, 6 months

Treatment Cost

Outcome is reported as the mean treatment cost in dollars.

Time frame: 6 months