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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan

NCT01847482

Cardiac Arrest

COMPLETED NA

Cardiogenic Shock Intravascular Cooling Trial

NCT03141255

Cardiogenic Shock

COMPLETED NA

COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest

NCT00843297

Cardiac Arrest Hypothermia

COMPLETED PHASE4

Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest

NCT02035839

Out-Of-Hospital Cardiac Arrest

COMPLETED NA

A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest

NCT01413399

Out-of-Hospital Cardiac Arrest

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Out of Hospital Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IVTM system, therapeutic hypothermia

Induced therapeutic hypothermia post cardiac arrest

ZOLL Intravascular Temperature Management System (IVTM)

Intervention Type DEVICE

Induced therapeutic hypothermia post cardiac arrest.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ZOLL Intravascular Temperature Management System (IVTM)

Induced therapeutic hypothermia post cardiac arrest.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No