Intracerebral HemorrhagePhase 1CCSICHNCT01933230
Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)
A Phase 1 study testing Excel Cryo Cooling System in people with Intracerebral Hemorrhage, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if cooling the neck of patients with ICH decreases brain temperature. In addition, the investigators will determine if the device improves the delivery of oxygen to the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Excel Cryo Cooling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients with brain injury in the Neurological ICU.
- Consent from the patient or surrogate decision maker.
- Warfarin induced intracerebral hemorrhages only after correction of INR to <1.4.
Who cannot join
- Cerebellar hemorrhages.
- Moribund state where the physician team doesn't believe the patient will survive.
- Patients who are being cared for with the intent of making them comfortable. DNR-CC (by Ohio law).
- Known history of a blood dyscrasia such as CLL or essential thrombocytosis that could affect inflammation.
- Known significant carotid artery stenosis (known >50% stenosis by history or incidental hospital imaging). This will not be specifically tested. Patients found to have significant stenosis later in the hospital stay will have their data interpreted separately as well as in the total group.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if cooling the neck of patients with ICH decreases brain temperature. In addition, the investigators will determine if the device improves the delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers intracranial pressure (which is often times high in patients after ICH).
Read the detailed description
This is a non-randomized device efficacy trial. Patients with >20cc Supratentorial ICH and an invasive brain temperature monitor (either Licox or Temperature sensing intracranial pressure device) will be enrolled after consent. The Excel Cryo Cooling System collar will be placed around neck in up to 20 patients for two hours. The goal is to determine the effectiveness of this device in cooling the brain. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. During the study and for two hours after, the investigators will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood (blood pressure). The investigators will also collect demographic information about you (i.e. age, gender, medical risk factors) and information regarding your current disease process.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Excel Cryo Cooling System
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excel Cryo Cooling SystemDevice
An Excel Cryo Cooling System collar will be place around the neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar. The cooling pack is similar to the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration. During the study and for two hours after, we will collect data concerning the brain temperature, body temperature, brain oxygen level, and pressure both in the head and in the blood.
2 hour neck cooling period
| Study group | Role | What they receive |
|---|---|---|
| Excel Cryo Cooling System Collar | Other | An Excel Cryo Cooling System collar will be placed around the neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar. The cooling pack is similar to the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration. During the study and for two hours after, we will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood. Receives: Device: Excel Cryo Cooling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature Reduction by 1 Degree Per Hour in the ICU Setting.
Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.
Measured: During the 2 hours of neck cooling
To Determine if Neck Cooling Affects Intracranial Pressure
Measured: During 2 hours of neck cooling
To Determine if Neck Cooling Affects Brain Temperature.
Measured: During the 2 hours of neck cooling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Closed due to issues encountered with meeting enrollment goals at our site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cryothermic Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- J. Javier Provencio, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933230
- Sponsor's protocol ID
- 13-121-CCSICH
- Acronym
- CCSICH
- Status last verified
- Feb 2015
- First submitted
- 23 Aug 2013
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)
- ClinicalTrials.gov ID
- NCT01933230
- Acronym / sponsor ID
- CCSICH / 13-121-CCSICH
- Conditions
- Intracerebral Hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to issues encountered with meeting enrollment goals at our site.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Cryothermic Systems, Inc.
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if cooling the neck of patients with ICH decreases brain temperature. In addition, the investigators will determine if the device improves the delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers intracranial pressure (which is often times high in patients after ICH).
Detailed description
This is a non-randomized device efficacy trial. Patients with >20cc Supratentorial ICH and an invasive brain temperature monitor (either Licox or Temperature sensing intracranial pressure device) will be enrolled after consent. The Excel Cryo Cooling System collar will be placed around neck in up to 20 patients for two hours. The goal is to determine the effectiveness of this device in cooling the brain. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. During the study and for two hours after, the investigators will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood (blood pressure). The investigators will also collect demographic information about you (i.e. age, gender, medical risk factors) and information regarding your current disease process.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excel Cryo Cooling System Collar | Other | Device: Excel Cryo Cooling SystemAn Excel Cryo Cooling System collar will be placed around the neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar. The cooling pack is similar to the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration. During the study and for two hours after, we will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with brain injury in the Neurological ICU.
- Consent from the patient or surrogate decision maker.
- Warfarin induced intracerebral hemorrhages only after correction of INR to <1.4.
Key exclusion criteria (5 listed)
- Cerebellar hemorrhages.
- Moribund state where the physician team doesn't believe the patient will survive.
- Patients who are being cared for with the intent of making them comfortable. DNR-CC (by Ohio law).
- Known history of a blood dyscrasia such as CLL or essential thrombocytosis that could affect inflammation.
- Known significant carotid artery stenosis (known >50% stenosis by history or incidental hospital imaging). This will not be specifically tested. Patients found to have significant stenosis later in the hospital stay will have their data interpreted separately as well as in the total group.
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 |
|---|---|---|
| Excel Cryo Cooling SystemAn Excel Cryo Cooling System collar will be place around the neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar. The cooling pack is similar to the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration. During the study and for two hours after, we will collect data concerning the brain temperature, body temperature, brain oxygen level, and pressure both in the head and in the blood. 2 hour neck cooling period | Device | Excel Cryo Cooling System Collar |
Primary outcome
Temperature Reduction by 1 Degree Per Hour in the ICU Setting.
Time frame: During the 2 hours of neck cooling
Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.
To Determine if Neck Cooling Affects Intracranial Pressure
Time frame: During 2 hours of neck cooling
To Determine if Neck Cooling Affects Brain Temperature.
Time frame: During the 2 hours of neck cooling
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
J. Javier Provencio principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Excel Cryo Cooling System in people with Intracerebral Hemorrhage, run by The Cleveland Clinic at 1 site 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Temperature Reduction by 1 Degree Per Hour in the ICU Setting. (time frame: During the 2 hours of neck cooling). The study lists 3 primary outcomes in all. 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 23 Feb 2017.