Advanced Reperfusion Strategies for Refractory Cardiac Arrest (ARREST)

University of Minnesota (UMN)

Status: Terminated

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

Treatments: Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation; Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03880565

CV-2018-27226

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

ECMO Facilitated Resuscitation

Experimental group

Description:

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.

Treatment:

Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation

Standard ACLS Resuscitation

Other group

Description:

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.

Treatment:

Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation