Advanced Reperfusion Strategies for Refractory Cardiac Arrest (ARREST)

February 28, 2022 updated by: University of Minnesota

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center, Fairview

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Early use of ECMO
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.
Standard life support resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: Approximately 25 days
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
Time Frame: At hospital discharge (average of 25 days), 3 months, 6 months
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
Time Frame: At hospital discharge (average of 25 days), 3 months, 6 months
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
Time Frame: 6 months
Outcome is reported as the mean treatment cost in dollars.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Demetris Yannopoulos, MD, University of Minnesota
  • Study Chair: Tom Aufderheide, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2019

Primary Completion (Actual)

October 9, 2020

Study Completion (Actual)

October 9, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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