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

Status: Terminated
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• 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.

Locations
United States
Minnesota
University of Minnesota Medical Center, Fairview
Minneapolis
Time Frame
Start Date: August 9, 2019
Completion Date: October 9, 2020
Participants
Target number of participants: 30
Treatments
Experimental: ECMO Facilitated Resuscitation
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.
Other: Standard ACLS Resuscitation
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.
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov

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