Cardiac ArrestNCT01847482
Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan
A study testing ZOLL Intravascular Temperature Management System (IVTM) in people with Cardiac Arrest, run by ZOLL Circulation, Inc., USA at 10 sites in Japan.
Trial summary
A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC) patients in Japan. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- ZOLL Intravascular Temperature Management System (IVTM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 10 sitesJapan
- Study dates
- Mar 2013to 19 Jan 2016
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-traumatic in-hospital or out-of-hospital cardiac arrest
- Unwitnessed cardiac arrest (Ventricular fibrillation), or witnessed cardiac arrest (ventricular fibrillation, pulseless electrical activity, asystole within 15 minutes following onset)
- Patient is at least 20 years of age and less than 80 years of age with consent is given
- In the judgement of an investigator or sub-investigator, the patient is unable to follow verbal instructions
- Therapeutic hypothermia using the investigational device can be initiated within six hours of Return of Spontaneous Circulation (ROSC)
- Written consent can be obtained from a legally acceptable representative
Who cannot join
- Traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc)
- Accidental hypothermia with core body temperature less than 35.0°C
- Pregnant or of child bearing potential
- Patient has given or indicated a Do Not Resuscitate (DNR) order
- Femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like
- An inferior vena cava filter is in place
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- Patient has severe bleeding (Pulmonary hemorrhage, gastrointestinal hemorrhage, etc.)
- Intracranial hemorrhage as confirmed by CT scanning
- Hemodynamic instability despite use of vasopressor agents and cardiac stimulants
- Heparin hypersensitivity
- Serious systemic infectious diseases (sepsis, etc.)
- Platelet count less than 30,000/mm3
- Serious hepatic dysfunction
- Serious renal impairment
- Using percutaneous cardiopulmonary support (PCPS)
- Using continuous hemodiafiltration (CHDF)
- Therapeutic hypothermia has been otherwise implemented between ROSC and the start of the study (excluding the rapid infusion of non-glucose-containing cold electrolyte fluid, or non-glucose-containing cold plasma volume expander)
- The patient's core body temperature cannot be monitored
- Currently participating in another clinical trial or has participated in another clinical trial within the past six months
- in the judgement of an investigator or sub-investigator, participation in this clinical trial is inappropriate for the patient
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Nipponn Medical School Hospital
Bunkyo, Tokyo, 113-8603
Surugadai Nihon University Hospital
Chiyoda City, Tokyo, 101-8309
Kagawa University School of Medicine
Hiragi, Kagawa-ken, 761-0793
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
Iwate Medical University Hospital
Morioka, Iwate, 020-8505
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, 663-8501
Osaka City General Hospital
Osaka, 534-0021
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
About this study
Official title: COOL-ARREST JP: A Multicenter, Prospective, Single-arm Interventional Trial to Evaluate Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients
A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC) patients in Japan.
The objective of this study is to verify that therapeutic hypothermia performed by intravascular cooling using the investigational device (IVTM) can control body temperature appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.
- Conditions
- Cardiac Arrest
- Being tested
- ZOLL Intravascular Temperature Management System (IVTM)
- Keywords
- Cardiac arrest, Return of Spontaneous Circulation (ROSC), IntraVascular Temperature Management (IVTM), Therapeutic Hypothermia, Japan
- Medical subject headings
- Heart 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 |
|---|---|---|
| Therapeutic Hypothermia | Experimental | Not described 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.
Core temperature achievement ratio
Measured: Baseline and 3 hours
Secondary outcomes (6)
Cerebral Performance Category (CPC)
Measured: Baseline and 14 days
Modified Rankin Scale (mRS)
Measured: Baseline and 14 days
Change in body temperature
Measured: Baseline and 96 hours
Cooling speed
Measured: Baseline and 3 hours
Safety
Incidence of adverse events at 2 days compared to baseline.
Measured: Baseline vs. 2 days
Safety
Incidence of adverse events at 14 days compared to baseline.
Measured: Baseline vs. 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completion19 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZOLL Circulation, Inc., USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asahi Kasei Medical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yoichi Kato, PhD, Study director, Asahi Kasei Medical Co., Ltd.Tsuyoshi Maekawa, MD, PhD, Principal investigator, Yamaguchi Grand Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847482
- Sponsor's protocol ID
- COOL-ARREST JP
- Status last verified
- Jun 2014
- First submitted
- 11 Feb 2013
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COOL-ARREST JP: A Multicenter, Prospective, Single-arm Interventional Trial to Evaluate Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients
- ClinicalTrials.gov ID
- NCT01847482
- Acronym / sponsor ID
- COOL-ARREST JP
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Return of Spontaneous Circulation (ROSC), IntraVascular Temperature Management (IVTM), Therapeutic Hypothermia, Japan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ZOLL Circulation, Inc., USAIndustry (pharma, biotech, devices)
- Collaborators
- Asahi Kasei Medical Co., Ltd.
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- 19 Jan 2016 (actual)
- First posted
- 6 May 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, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC) patients in Japan.
The objective of this study is to verify that therapeutic hypothermia performed by intravascular cooling using the investigational device (IVTM) can control body temperature appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Hypothermia | Experimental | Device: ZOLL Intravascular Temperature Management System (IVTM) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-traumatic in-hospital or out-of-hospital cardiac arrest
- Unwitnessed cardiac arrest (Ventricular fibrillation), or witnessed cardiac arrest (ventricular fibrillation, pulseless electrical activity, asystole within 15 minutes following onset)
- Patient is at least 20 years of age and less than 80 years of age with consent is given
- In the judgement of an investigator or sub-investigator, the patient is unable to follow verbal instructions
- Therapeutic hypothermia using the investigational device can be initiated within six hours of Return of Spontaneous Circulation (ROSC)
Key exclusion criteria (20 listed)
- Traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc)
- Accidental hypothermia with core body temperature less than 35.0°C
- Pregnant or of child bearing potential
- Patient has given or indicated a Do Not Resuscitate (DNR) order
- Femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like
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 | Therapeutic Hypothermia |
Primary outcome
Core temperature achievement ratio
Time frame: Baseline and 3 hours
6 secondary outcomes
Cerebral Performance Category (CPC)
Time frame: Baseline and 14 days
Modified Rankin Scale (mRS)
Time frame: Baseline and 14 days
Change in body temperature
Time frame: Baseline and 96 hours
Cooling speed
Time frame: Baseline and 3 hours
Safety
Time frame: Baseline vs. 2 days
Safety
Time frame: Baseline vs. 14 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 27 Jun 2018.
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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.
Yoichi Kato, PhD study director
Asahi Kasei Medical Co., Ltd.
Tsuyoshi Maekawa, MD, PhD principal investigator
Yamaguchi Grand Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZOLL Intravascular Temperature Management System (IVTM) in people with Cardiac Arrest, run by ZOLL Circulation, Inc., USA at 10 sites in Japan.
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 6 inclusion and 20 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 27 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 10 sites in Japan. 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?
Core temperature achievement ratio (time frame: Baseline and 3 hours). 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 27 Jun 2018.