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

Out of Hospital Cardiac Arrest Clinical Trial

— COOL-ARREST  

Official title:

A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818388
• Other study ID #: EDC-1978
• Status: Completed
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: ZOLL Circulation, Inc., USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• Out of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• ZOLL Intravascular Temperature Management System (IVTM)
Induced therapeutic hypothermia post cardiac arrest.

Locations

Country	Name	City	State
United States	Chattanooga Center for Neurologic Research	Chattanooga	Tennessee
United States	Palmetto Health Clinical Trials Department	Columbia	South Carolina
United States	Wayne State University / Detriot Medical Center	Detroit	Michigan
United States	Greenville Hospital System	Greenville	South Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
ZOLL Circulation, Inc., USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance		Day 1
Secondary	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
Secondary	Incident Adverse Events Defined as Safety		Up to 90 days