Advanced Reperfusion Strategies for Refractory Cardiac Arrest

Not Applicable

Terminated

• Conditions: Extracorporeal Membrane Oxygenation Complication; Pulseless Ventricular Tachycardia; Out-Of-Hospital Cardiac Arrest; Cardiac Arrest; Ventricular Fibrillation
• Interventions: Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation; Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation

• Registration Number: NCT03880565
• Lead Sponsor: University of Minnesota

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-19
• Study Start: 2019-08-09
• Primary Completion: 2020-10-09
• Study Completion: 2020-10-09
• Results First Submitted: 2021-09-20
• Results First Submitted QC: 2021-11-18
• Results First Posted: 2021-11-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECMO Facilitated Resuscitation	Early Extracorporeal Membrane Oxygenation (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.
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.

Primary Outcome Measures

Name	Time	Method
Survival	Approximately 25 days	Number of participants who survived to hospital discharge

Secondary Outcome Measures

Name	Time	Method
Cerebral Performance Categories (CPC) Scale	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.
Treatment Cost	6 months	Outcome is reported as the mean treatment cost in dollars.
Modified Rankin Scale (mRS) Score	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.

Trial Locations

Locations (1)

University of Minnesota Medical Center, Fairview; 🇺🇸 Minneapolis, Minnesota, United States