Out of Hospital Cardiac ArrestCOOL-ARRESTNCT01818388
COOL-ARREST Pilot Study to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
An observational study of Out of Hospital Cardiac Arrest, run by ZOLL Circulation, Inc., USA at 9 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest
- What is being tested?
- ZOLL Intravascular Temperature Management System (IVTM)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects that have experienced an out-of-hospital cardiac arrest.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Terminal illness or life expectancy of less than 3 months prior to arrest
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37403
Palmetto Health Clinical Trials Department
Columbia, South Carolina, 29203
Wayne State University / Detriot Medical Center
Detroit, Michigan, 48201
Greenville Hospital System
Greenville, South Carolina, 29605
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
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
- Being tested
- ZOLL Intravascular Temperature Management System (IVTM)
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOLL Intravascular Temperature Management System (IVTM)Device
Induced therapeutic hypothermia post cardiac arrest.
| Study group | Role | What they receive |
|---|---|---|
| IVTM system, therapeutic hypothermia | Induced therapeutic hypothermia post cardiac arrest Receives: Device: ZOLL Intravascular Temperature Management System (IVTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance
Measured: 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
Measured: Up to 90 days
Incident Adverse Events Defined as Safety
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out of Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZOLL Circulation, Inc., USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian O'Neil, MD, Principal investigator, Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818388
- Sponsor's protocol ID
- EDC-1978
- Acronym
- COOL-ARREST
- Status last verified
- Apr 2016
- First submitted
- 4 Feb 2013
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Single Arm Observational Trial to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01818388
- Acronym / sponsor ID
- COOL-ARREST / EDC-1978
- Conditions
- Out of Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ZOLL Circulation, Inc., USAIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVTM system, therapeutic hypothermia | – | Device: ZOLL Intravascular Temperature Management System (IVTM)Induced therapeutic hypothermia post cardiac arrest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that have experienced an out-of-hospital cardiac arrest.
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZOLL Intravascular Temperature Management System (IVTM)Induced therapeutic hypothermia post cardiac arrest. | Device | IVTM system, therapeutic hypothermia |
Primary outcome
Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance
Time frame: Day 1
2 secondary outcomes
Ability to Enroll Subjects, Proportion of those Enrolled that Complete the Study Protocol and Time to complete Enrollment of 50 Subjects Defined as Retention
Time frame: Up to 90 days
Incident Adverse Events Defined as Safety
Time frame: Up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Out of Hospital Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian O'Neil, MD principal investigator
Wayne State University, School of Medicine Specialist and Chief, Detroit Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out of Hospital Cardiac Arrest, run by ZOLL Circulation, Inc., USA at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects in which IVTM can therapeutically cool patients as a measure of Performance (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.