Advanced Reperfusion Strategies for Refractory Cardiac Arrest

NCT ID: NCT03880565

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-09
• Study Completion Date: 2020-10-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation

Intervention Type: DEVICE

Early use of ECMO

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.

Group Type: OTHER

Standard Advanced Cardiac Life Support (ACLS) Resuscitation

Intervention Type: DEVICE

Standard life support resuscitation

Interventions

Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation

Early use of ECMO

Intervention Type: DEVICE

Standard Advanced Cardiac Life Support (ACLS) Resuscitation

Standard life support resuscitation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Demetris Yannopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Tom Aufderheide, MD

Role: STUDY_CHAIR

University of Minnesota

Locations

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33197396 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CV-2018-27226

Identifier Type: -

Identifier Source: org_study_id