Severe Traumatic Brain InjuryPhase 3NCT00676104
Discrete Hypothermia in the Management of Traumatic Brain Injury
A Phase 3 study testing CoolSystems Discrete Cerebral Hypothermia System in people with Severe Traumatic Brain Injury, run by Emory University at 1 site in United States.
Trial summary
The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Traumatic Brain Injury
- What is being tested?
- CoolSystems Discrete Cerebral Hypothermia System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Oct 2008
- Phase
- Phase 3
- 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
Who may be able to join
- Patient is treated for severe traumatic brain injury at Grady Health System, GCS < 8
- Patient is >18 years of age
- Patient requires an Intracranial Pressure (ICP) Probe (part of their routine treatment)
- Patient is able to receive Discrete Cerebral Hypothermia within 48-hours of hospital admission
- Patient and/or guardian must speak English (in order to ensure proper Informed Consent)
- Patient and/or guardian/family must sign an Informed Consent
Who cannot join
- Unwillingness or inability of patient and/or guardian/ family to sign an informed consent
- Physical placement of cooling cap impedes routine treatment
- Patient has a core body temperature of 36 degrees C or less at time of assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine, Grady Health System campus
Atlanta, Georgia, 30303
About this study
The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.
- Conditions
- Severe Traumatic Brain Injury
- Being tested
- CoolSystems Discrete Cerebral Hypothermia System
- Keywords
- Traumatic Brain Injury, Trauma, Hypothermia
- Medical subject headings
- Brain Injuries, Traumatic, Wounds and Injuries, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolSystems Discrete Cerebral Hypothermia SystemDevice
The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: CoolSystems Discrete Cerebral Hypothermia System |
| Control | Sham comparator | Not described Receives: Device: CoolSystems Discrete Cerebral Hypothermia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perform a comparative analysis of outcome (Glasgow Outcome Score)
Measured: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Secondary outcomes (4)
The effectiveness of the Discrete Cerebral Hypothermia System by CoolSystems in maintaining a significant gradient between the core and brain temperatures in study population.
Measured: within 3 days after injury
Functional Independence Measure
Measured: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Mortality
Measured: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature
Measured: within 3 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startJul 2006
- Primary completionAug 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Surles, Emory University
- Investigators
- Odette A Harris, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676104
- Sponsor's protocol ID
- 0584-2005
- Status last verified
- Dec 2013
- First submitted
- 8 May 2008
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discrete Hypothermia in the Management of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00676104
- Acronym / sponsor ID
- 0584-2005
- Conditions
- Severe Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Trauma, Hypothermia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 May 2008 (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.
The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: CoolSystems Discrete Cerebral Hypothermia System |
| Control | Sham comparator | Device: CoolSystems Discrete Cerebral Hypothermia System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is treated for severe traumatic brain injury at Grady Health System, GCS < 8
- Patient is >18 years of age
- Patient requires an Intracranial Pressure (ICP) Probe (part of their routine treatment)
- Patient is able to receive Discrete Cerebral Hypothermia within 48-hours of hospital admission
- Patient and/or guardian must speak English (in order to ensure proper Informed Consent)
Key exclusion criteria (3 listed)
- Unwillingness or inability of patient and/or guardian/ family to sign an informed consent
- Physical placement of cooling cap impedes routine treatment
- Patient has a core body temperature of 36 degrees C or less at time of assessment
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 |
|---|---|---|
| CoolSystems Discrete Cerebral Hypothermia SystemThe CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours. | Device | Control, Treatment |
Primary outcome
Perform a comparative analysis of outcome (Glasgow Outcome Score)
Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
4 secondary outcomes
The effectiveness of the Discrete Cerebral Hypothermia System by CoolSystems in maintaining a significant gradient between the core and brain temperatures in study population.
Time frame: within 3 days after injury
Functional Independence Measure
Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Mortality
Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature
Time frame: within 3 days after injury
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 20 Dec 2013.
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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.
Odette A Harris, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CoolSystems Discrete Cerebral Hypothermia System in people with Severe Traumatic Brain Injury, run by Emory University 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 6 inclusion and 3 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 20 Dec 2013. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Perform a comparative analysis of outcome (Glasgow Outcome Score) (time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury). 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 20 Dec 2013.