COOL-ARREST Pilot Study to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest (COOL-ARREST)

A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest

A multicenter prospective single arm interventional trial in hospitals where therapeutic hypothermia is standard practice. This trial will enroll 50 subjects to evaluate the ability of the ZOLL Intravascular Temperature Management (IVTM) System to induce, maintain, and reverse mild therapeutic hypothermia and maintain normothermia post cardiac arrest.

Study Overview

• Status: Completed
• Conditions: Out of Hospital Cardiac Arrest
• Intervention / Treatment: Device: ZOLL Intravascular Temperature Management System (IVTM)

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Britain, Connecticut, United States, 06050
      • The Hospital of Central Connecticut
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University / Detriot Medical Center
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health Clinical Trials Department
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Chattanooga Center for Neurologic Research
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects that have experienced an out-of-hospital cardiac arrest.

Description

Inclusion criteria:

1. Signed informed consent
2. 18 years of age or older

3. Out-of-hospital witnessed cardiac arrest with any rhythm [Ventricular Fibrillation/Tachycardia (VF/VT), Pulseless Electrical Activity (PEA), or Asystole (AS)] during EMS phase of treatment

   OR:

   Out-of-hospital unwitnessed cardiac arrest with VF upon EMS arrival

4. Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
5. Return of spontaneous circulation (ROSC) within 30 minutes of EMS arrival
6. Able to maintain a SBP > 90mmHg for 30 minutes post ROSC without the use of pressors OR with stable dose of pressors (if escalation of pressors is required, patient is not eligible)
7. Undergoing Therapeutic Hypothermia using ZOLL's IVTM System within twelve hours of ROSC BUT should have been initiated as soon as possible

Exclusion Criteria

1. Traumatic cardiac arrest [due to blunt trauma, penetrating injury (e.g., stabbing, gunshot, etc.), burns, exsanguinations, strangulation, smoke inhalation, electrocution, hanging, drowning, etc.]
2. Toxicological etiology (e.g., inhalation of toxic substances, drugs, etc.)
3. Known or suspected pregnancy
4. Do Not Attempt to Resuscitate (DNAR) order in force
5. Ward of the state or prisoner
6. Anatomy, previous surgery or disease state contraindicating femoral venous access
7. Received neuromuscular blocking agents or central nervous system sedatives whose effects have not worn off prior to assessing level of consciousness following ROSC
8. Hypothermia initiated at a transferring facility prior to arrival at the enrolling hospital (excludes pre-hospital IV fluids or cold packs for cooling by EMS)
9. Current Inferior Vena Cava (IVC) filter
10. Known history of acute neurological illness or severe functional disabilities prior to arrest (e.g., seizures, traumatic brain injury, increased intracranial pressures, intracerebral hemorrhage, etc.)
11. Known heparin allergy
12. Known allergy to any adjunctive pharmacologic agent required for induction or maintenance of therapeutic hypothermia
13. Known history of bleeding or blood disorders such as coagulopathy, cryoglobulinemia, sickle cell or thrombocytopenia with a platelet count below 40,000.
14. Known hypersensitivity to hypothermia including a history of Raynaud's disease
15. Evidence of intracranial bleed
16. Terminal illness or life expectancy of less than 3 months prior to arrest
17. Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's endpoints Note: For the purpose of this protocol, subjects involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IVTM system, therapeutic hypothermia; Induced therapeutic hypothermia post cardiac arrest	Device: ZOLL Intravascular Temperature Management System (IVTM); Induced therapeutic hypothermia post cardiac arrest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Ability to Enroll Subjects, Proportion of those Enrolled that Complete the Study Protocol and Time to complete Enrollment of 50 Subjects Defined as Retention	Up to 90 days
Incident Adverse Events Defined as Safety	Up to 90 days

Collaborators and Investigators

• Sponsor: ZOLL Circulation, Inc., USA
• Investigators: Principal Investigator: Brian O'Neil, MD, Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 26, 2013

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: EDC-1978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided