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

Exclusion Criteria

• •7. Undergoing Therapeutic Hypothermia using ZOLL's IVTM System within twelve hours of ROSC BUT should have been initiated as soon as possible
• •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.