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

June 25, 2018 updated by: ZOLL Circulation, Inc., USA

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Up to 90 days
Up to 90 days
Incident Adverse Events Defined as Safety
Time Frame: Up to 90 days
Up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ZOLL Circulation, Inc., USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian O'Neil, MD, Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EDC-1978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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