Clinical trial NCT03880565: Advanced Reperfusion Strategies for Refractory Cardiac Arrest
Official title: Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Arrest
Extracorporeal Membrane Oxygenation Complication
Ventricular Fibrillation
Pulseless Ventricular Tachycardia
Out-Of-Hospital Cardiac Arrest
Keywords: advanced reperfusion
mechanical cardiopulmonary resuscitation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: Approximately 25 days
Secondary outcomes:
measure: Modified Rankin Scale (mRS) Score
timeFrame: At hospital discharge (average of 25 days), 3 months, 6 months
measure: Cerebral Performance Categories (CPC) Scale
timeFrame: At hospital discharge (average of 25 days), 3 months, 6 months
measure: Treatment Cost
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Demetris Yannopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Tom Aufderheide, MD
role: STUDY_CHAIR
References:
citation: Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13.