Advanced Reperfusion Strategies for Refractory Cardiac Arrest

NCT03880565 | Terminated Results DMC FDA Device

• 1 other identifier: CV-2018-27226
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Arrest; Extracorporeal Membrane Oxygenation Complication; Ventricular Fibrillation; Pulseless Ventricular Tachycardia; Out-Of-Hospital Cardiac Arrest

Keywords

advanced reperfusion; mechanical cardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

• Survival

  Number of participants who survived to hospital discharge

  Approximately 25 days

Secondary Outcomes (3)

• Modified Rankin Scale (mRS) Score

  At hospital discharge (average of 25 days), 3 months, 6 months

• Cerebral Performance Categories (CPC) Scale

  At hospital discharge (average of 25 days), 3 months, 6 months

• Treatment Cost

  6 months

Study Arms (2)

ECMO Facilitated Resuscitation

EXPERIMENTAL

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.

Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation

Standard ACLS Resuscitation

OTHER

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

Interventions

Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation DEVICE

Early use of ECMO

ECMO Facilitated Resuscitation

Standard Advanced Cardiac Life Support (ACLS) Resuscitation DEVICE

Standard life support resuscitation

Standard ACLS Resuscitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 33197396 DERIVED

MeSH Terms

Conditions

Heart Arrest; Ventricular Fibrillation; Out-of-Hospital Cardiac Arrest

Interventions

Extracorporeal Membrane Oxygenation; Resuscitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Emergency Treatment

Results Point of Contact

• Title: Demetri Yannopoulos, MD
• Organization: University of Minnesota

yanno001@umn.edu

612-626-2935

Study Officials

• Demetris Yannopoulos, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Tom Aufderheide, MD

  University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 19, 2019
• Study Start: August 9, 2019
• Primary Completion: October 9, 2020
• Study Completion: October 9, 2020
• Last Updated: March 10, 2022
• Results First Posted: November 22, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)