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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by ZOLL Circulation, Inc., USA
Sponsor:
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier:
NCT01818388
First received: February 4, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Out of Hospital Cardiac Arrest
Device: ZOLL Intravascular Temperature Management System (IVTM)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by ZOLL Circulation, Inc., USA:

Primary Outcome Measures:
  • Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incident Adverse Events Defined as Safety [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IVTM system, therapeutic hypothermia
Induced therapeutic hypothermia post cardiac arrest
Device: ZOLL Intravascular Temperature Management System (IVTM)
Induced therapeutic hypothermia post cardiac arrest

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818388

Contacts
Contact: Renee Kochevar, PhD, ALM 408-419-2904 rkochevar@zollcirculation.com

Locations
United States, Connecticut
The Hospital of Central Connecticut Not yet recruiting
New Britain, Connecticut, United States, 06050
Contact: Justin Lundbye, M.D.    860-224-5731    jlundbye@thocc.org   
Contact: Deborah Katten    860-545-1537    dkatten@harthosp.rg   
Principal Investigator: Justin Lundbye, M.D., M.D.         
United States, Michigan
Wayne State University / Detriot Medical Center Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Gregory Norris    313-745-1540    gnorris@med.wayne.edu   
Contact: Robert Kas-Shamoun, RN    313-745-4414    rkassham@med.wayne.edu   
Principal Investigator: Gregory Norris         
William Beaumont Hospital Not yet recruiting
Royal Oak, Michigan, United States, 48073
Contact: Kelly Sawyer, M.D.    248-898-0189    Kelly.sawyer@beaumont.edu   
Contact: Ryan Paternoster    248-898-6005    ryan.paternoster@beaumont.edu   
Principal Investigator: Kelly Sawyer, M.D.         
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Mike Mooney, M.D.    603-650-7047    Michael.Mooney@allina.com   
Contact: Dave Hildebrandt    612-863-4085    david.hildebrandt@allina.com   
Principal Investigator: Mike Mooney, M.D.         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Alan Kono, M.D    603-650-2929    Alan.T.Kono@dartmouth.edu   
Contact: Norman Paradis, M.D    603-650-7047    norman.a.paradis@hitchcock.org   
Principal Investigator: Alan Kono, M.D         
United States, South Carolina
Palmetto Health Clinical Trials Department Not yet recruiting
Columbia, South Carolina, United States, 29203
Contact: J. Kyle Hewett, M.D.    803-434-3800    hewettkyle@gmail.com   
Contact: Heather Homolek    803-434-6365    heather.homolek@palmettohealth.org   
Principal Investigator: J. Kyle Hewett, M.D.         
Greenville Hospital System Not yet recruiting
Greenville, South Carolina, United States, 29605
Contact: Jesse Jorgensen, M.D.    864-455-6900    jjorgensen@ghs.org   
Contact: Maureen Coyne    864-455-7727    mcoyne@ghs.org   
Principal Investigator: Jesse Jorgensen, M.D.         
United States, Texas
University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Pratik Doshi, M.D.    713-500-7585    Pratik.B.Doshi@uth.tmc.edu   
Contact: Teresa Camp-Rogers, M.D.    713-500-7138    Teresa.R.Camprogers@uth.tmc.edu   
Principal Investigator: Pratik Doshi, M.D.         
Sponsors and Collaborators
ZOLL Circulation, Inc., USA
Investigators
Principal Investigator: Brian O'Neil, MD Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center
  More Information

No publications provided

Responsible Party: ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier: NCT01818388     History of Changes
Other Study ID Numbers: EDC-1978
Study First Received: February 4, 2013
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014