Clinical trial NCT01818388: COOL-ARREST Pilot Study to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
Official title: A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out of Hospital Cardiac Arrest
Lead sponsor: ZOLL Circulation, Inc., USA
Sponsor class: INDUSTRY
First posted: 2013-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that have experienced an out-of-hospital cardiac arrest.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance
timeFrame: Day 1
Secondary outcomes:
measure: Ability to Enroll Subjects, Proportion of those Enrolled that Complete the Study Protocol and Time to complete Enrollment of 50 Subjects Defined as Retention
timeFrame: Up to 90 days
measure: Incident Adverse Events Defined as Safety
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: Detroit
country: United States
facility: Wayne State University / Detriot Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Columbia
country: United States
facility: Palmetto Health Clinical Trials Department
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Center for Neurologic Research
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center
name: Brian O'Neil, MD
role: PRINCIPAL_INVESTIGATOR
References: