COOL-ARREST Pilot Study to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| IVTM system, therapeutic hypothermia Induced therapeutic hypothermia post cardiac arrest |
Device: ZOLL Intravascular Temperature Management System (IVTM)
Induced therapeutic hypothermia post cardiac arrest.
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance [Day 1]
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 [Up to 90 days]
- Incident Adverse Events Defined as Safety [Up to 90 days]
Eligibility Criteria
Criteria
Inclusion criteria:
-
Signed informed consent
-
18 years of age or older
-
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
-
Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
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Return of spontaneous circulation (ROSC) within 30 minutes of EMS arrival
-
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)
-
Undergoing Therapeutic Hypothermia using ZOLL's IVTM System within twelve hours of ROSC BUT should have been initiated as soon as possible
Exclusion Criteria
-
Traumatic cardiac arrest [due to blunt trauma, penetrating injury (e.g., stabbing, gunshot, etc.), burns, exsanguinations, strangulation, smoke inhalation, electrocution, hanging, drowning, etc.]
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Toxicological etiology (e.g., inhalation of toxic substances, drugs, etc.)
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Known or suspected pregnancy
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Do Not Attempt to Resuscitate (DNAR) order in force
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Ward of the state or prisoner
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Anatomy, previous surgery or disease state contraindicating femoral venous access
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Received neuromuscular blocking agents or central nervous system sedatives whose effects have not worn off prior to assessing level of consciousness following ROSC
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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)
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Current Inferior Vena Cava (IVC) filter
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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.)
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Known heparin allergy
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Known allergy to any adjunctive pharmacologic agent required for induction or maintenance of therapeutic hypothermia
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Known history of bleeding or blood disorders such as coagulopathy, cryoglobulinemia, sickle cell or thrombocytopenia with a platelet count below 40,000.
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Known hypersensitivity to hypothermia including a history of Raynaud's disease
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Evidence of intracranial bleed
-
Terminal illness or life expectancy of less than 3 months prior to arrest
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hospital of Central Connecticut | New Britain | Connecticut | United States | 06050 |
| 2 | Wayne State University / Detriot Medical Center | Detroit | Michigan | United States | 48201 |
| 3 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 4 | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | United States | 55407 |
| 5 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 6 | Palmetto Health Clinical Trials Department | Columbia | South Carolina | United States | 29203 |
| 7 | Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
| 8 | Chattanooga Center for Neurologic Research | Chattanooga | Tennessee | United States | 37403 |
| 9 | University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EDC-1978