Advanced Reperfusion Strategies for Refractory Cardiac Arrest

Cardiac Arrest Clinical Trial

— ARREST  

Official title:

Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03880565
• Other study ID #: CV-2018-27226
• Status: Terminated
• Phase: N/A
• Start date: August 9, 2019
• Est. completion date: October 9, 2020

Study information

• Verified date: February 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 9, 2020
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Extracorporeal Membrane Oxygenation Complication
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Pulseless Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation

Intervention

Device:
• Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation
Early use of ECMO
• Standard Advanced Cardiac Life Support (ACLS) Resuscitation
Standard life support resuscitation

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Number of participants who survived to hospital discharge	Approximately 25 days
Secondary	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.	At hospital discharge (average of 25 days), 3 months, 6 months
Secondary	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.	At hospital discharge (average of 25 days), 3 months, 6 months
Secondary	Treatment Cost	Outcome is reported as the mean treatment cost in dollars.	6 months