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Advanced Reperfusion Strategies for Refractory Cardiac Arrest (ARREST)

Primary Purpose

Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication, Ventricular Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation
Standard Advanced Cardiac Life Support (ACLS) Resuscitation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring advanced reperfusion, mechanical cardiopulmonary resuscitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Minnesota Medical Center, Fairview

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ECMO Facilitated Resuscitation

Standard ACLS Resuscitation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Survival
Number of participants who survived to hospital discharge

Secondary Outcome Measures

Modified Rankin Scale (mRS) Score
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.
Cerebral Performance Categories (CPC) Scale
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.
Treatment Cost
Outcome is reported as the mean treatment cost in dollars.

Full Information

First Posted
March 11, 2019
Last Updated
February 28, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03880565
Brief Title
Advanced Reperfusion Strategies for Refractory Cardiac Arrest
Acronym
ARREST
Official Title
Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
For early efficacy
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
October 9, 2020 (Actual)
Study Completion Date
October 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication, Ventricular Fibrillation, Pulseless Ventricular Tachycardia, Out-Of-Hospital Cardiac Arrest
Keywords
advanced reperfusion, mechanical cardiopulmonary resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECMO Facilitated Resuscitation
Arm Type
Experimental
Arm 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.
Arm Title
Standard ACLS Resuscitation
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation
Intervention Description
Early use of ECMO
Intervention Type
Device
Intervention Name(s)
Standard Advanced Cardiac Life Support (ACLS) Resuscitation
Intervention Description
Standard life support resuscitation
Primary Outcome Measure Information:
Title
Survival
Description
Number of participants who survived to hospital discharge
Time Frame
Approximately 25 days
Secondary Outcome Measure Information:
Title
Modified Rankin Scale (mRS) Score
Description
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.
Time Frame
At hospital discharge (average of 25 days), 3 months, 6 months
Title
Cerebral Performance Categories (CPC) Scale
Description
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.
Time Frame
At hospital discharge (average of 25 days), 3 months, 6 months
Title
Treatment Cost
Description
Outcome is reported as the mean treatment cost in dollars.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demetris Yannopoulos, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tom Aufderheide, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33197396
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.
Results Reference
derived

Learn more about this trial

Advanced Reperfusion Strategies for Refractory Cardiac Arrest

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