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Advanced Reperfusion Strategies for Refractory Cardiac Arrest (ARREST)

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ClinicalTrials.gov Identifier: NCT03880565
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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

Condition or disease Intervention/treatment Phase
Cardiac Arrest Extracorporeal Membrane Oxygenation Complication Ventricular Fibrillation Pulseless Ventricular Tachycardia Out-Of-Hospital Cardiac Arrest Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023


Arm Intervention/treatment
Experimental: ECMO Facilitated Resuscitation
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation
Early use of ECMO

Standard ACLS Resuscitation
Standard Advanced Cardiac Life Support (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.
Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation
Standard life support resuscitation




Primary Outcome Measures :
  1. Survival [ Time Frame: 1 week ]
    Survival to hospital discharge.


Secondary Outcome Measures :
  1. Survival to hospital discharge with modified Rankin Scale Score (mRS) ≤ 3 along with functional status (Cerebral Performance Category [CPC]) [ Time Frame: 1 week, 3 months, 6 months ]
    Survival to hospital discharge with mRS ≤ 3 along with functional status as measured by CPC. mRS scale ranges from 0 (no residual symptoms) to 6 (dead) with 7 (unable to contact patient/caregiver) and 8 (mRS not performed). 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. CPC scale ranges from 1 (good cerebral performance) to 5 (brain death). CPC scores of 2 (moderate cerebral disability) and 1 indicate functional status.

  2. Treatment cost [ Time Frame: 6 months ]
    Cost per patient and cost per life saved



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880565


Contacts
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Contact: Emily Walser 612-626-3656 emilyw@umn.edu

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Demetris Yannopoulos, MD University of Minnesota - Clinical and Translational Science Institute
Study Chair: Tom Aufderheide, MD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03880565     History of Changes
Other Study ID Numbers: Arrest
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
advanced reperfusion
mechanical cardiopulmonary resuscitation

Additional relevant MeSH terms:
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Heart Arrest
Tachycardia
Tachycardia, Ventricular
Out-of-Hospital Cardiac Arrest
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes