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

This study is not yet open for participant recruitment.
Verified March 2013 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: March 21, 2013
Last verified: March 2013
  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: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Single Arm Interventional 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 Suubjects, 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: March 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induced 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
Criteria

Inclusion Criteria:

  • Signed Informed Consent
  • 18 years of age or older
  • Out-of-hospital witnessed arrest or unwitnessed arrest
  • Return to spontaneous circulation within 30 min of EMS arrival

Exclusion Criteria:

  • Traumatic cardiac arrest
  • Toxicological etiology
  • known or suspected pregnancy
  • Do Not Attempt to Resuscitate order in force
  • Ward of the state or prisoner
  • Anatomy, previous surgery or disease state contraindicating femoral venous access
  • Hypothermia initiated at a transferring facility prior to arrival at the enrolling hospital
  • History of acute neurological illness or severe functional disabilities prior to arrest
  • Known history of bleeding or blood disorders
  • History of Raynaud's disease
  • Evidence of intracranial bleed
  • Terminal illness of life expectancy of less than 3 months
  • Currently enrolled in another investigational drug or device trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818388

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

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: March 21, 2013
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 April 15, 2014