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

NCT01818388 | Completed DMC

• 1 other identifier: EDC-1978
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 9

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.

Conditions

Out of Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance

  Day 1

Secondary Outcomes (2)

• 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

Study Arms (1)

IVTM system, therapeutic hypothermia

Induced therapeutic hypothermia post cardiac arrest

Device: ZOLL Intravascular Temperature Management System (IVTM)

Interventions

ZOLL Intravascular Temperature Management System (IVTM) DEVICE

Induced therapeutic hypothermia post cardiac arrest.

IVTM system, therapeutic hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects that have experienced an out-of-hospital cardiac arrest.

You may qualify if:

• Signed informed consent
• 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
• 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

You may not qualify if:

• Traumatic cardiac arrest \[due to blunt trauma, penetrating injury (e.g., stabbing, gunshot, etc.), burns, exsanguinations, strangulation, smoke inhalation, electrocution, hanging, drowning, etc.\]
• Toxicological etiology (e.g., inhalation of toxic substances, drugs, etc.)
• Known or suspected pregnancy
• Do Not Attempt to Resuscitate (DNAR) order in force
• Ward of the state or prisoner
• Anatomy, previous surgery or disease state contraindicating femoral venous access
• Received neuromuscular blocking agents or central nervous system sedatives whose effects have not worn off prior to assessing level of consciousness following ROSC
• 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)
• Current Inferior Vena Cava (IVC) filter
• 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.)
• Known heparin allergy
• Known allergy to any adjunctive pharmacologic agent required for induction or maintenance of therapeutic hypothermia
• Known history of bleeding or blood disorders such as coagulopathy, cryoglobulinemia, sickle cell or thrombocytopenia with a platelet count below 40,000.
• Known hypersensitivity to hypothermia including a history of Raynaud's disease
• Evidence of intracranial bleed

Sponsors & Collaborators

• ZOLL Circulation, Inc., USA: lead

Study Sites (9)

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Wayne State University / Detriot Medical Center

Detroit, Michigan, 48201, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Palmetto Health Clinical Trials Department

Columbia, South Carolina, 29203, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Chattanooga Center for Neurologic Research

Chattanooga, Tennessee, 37403, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Brian O'Neil, MD

  Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: March 26, 2013
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 26, 2018

Record last verified: 2016-04

Locations

US (9)