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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01818388
First Posted: March 26, 2013
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA
February 4, 2013
March 26, 2013
April 27, 2016
July 2014
July 2015   (Final data collection date for primary outcome measure)
Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance [ Time Frame: Day 1 ]
Same as current
Complete list of historical versions of study NCT01818388 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incident Adverse Events Defined as Safety [ Time Frame: Up to 90 days ]
  • 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 ]
  • Incident Adverse Events Defined as Safety [ Time Frame: Up to 90 days ]
Not Provided
Not Provided
 
COOL-ARREST Pilot Study to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac 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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Subjects that have experienced an out-of-hospital cardiac arrest.
Out of Hospital Cardiac Arrest
Device: ZOLL Intravascular Temperature Management System (IVTM)
Induced therapeutic hypothermia post cardiac arrest.
IVTM system, therapeutic hypothermia
Induced therapeutic hypothermia post cardiac arrest
Intervention: Device: ZOLL Intravascular Temperature Management System (IVTM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2015
July 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01818388
EDC-1978
Yes
Not Provided
Plan to Share IPD: Undecided
ZOLL Circulation, Inc., USA
ZOLL Circulation, Inc., USA
Not Provided
Principal Investigator: Brian O'Neil, MD Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center
ZOLL Circulation, Inc., USA
April 2016