- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880565
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
Status
Terminated
Conditions
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
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center, Fairview
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-
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.
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Standard life support resuscitation
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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.
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At hospital discharge (average of 25 days), 3 months, 6 months
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV-2018-27226
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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