Brain Injuries, TraumaticPhase 3NCT00134472
Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
A Phase 3 study testing Therapeutic mild hypothermia in people with Brain Injuries, Traumatic, run by Yamaguchi University Hospital at 43 sites in Japan.
Trial summary
The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome. Read more about this study
- Who is it for?
- Ages 15 to 69 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Therapeutic mild hypothermia
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 43 sitesJapan
- Study dates
- Dec 2002to Sep 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 15 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
- Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.
Who cannot join
- Systolic blood pressure < 90mmHg (after resuscitation)
- Thrombocytopenia (platelets [Plt] < 50,000/mm3)
- Pregnancy
- Preexisting medical conditions of severe hepatic dysfunction, heart failure or any other severe organ failure
- Deep drunkenness
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Japan43 sites
Nippon Medical School
Bunkyo, Tokyo, 1138603
The University of Tokyo Hospital
Bunkyo, Tokyo, 1138655
Chiba University Hospital
Chiba, Chiba, 2608677
Chiba Emergency Medical Center
Chiba, Chiba, 2610012
National Hospital Organization Osaka National Hospital
Cyuo, Osaka, 5400006
Gifu University Hospital
Gifu, Gifu, 5011194
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 1930998
Kanazawa University
Kanazawa, Ishikawa-ken, 9208640
Nara Medical University
Kashihara, Nara, 6348522
Saitama Medical Center
Kawagoe, Saitama, 3508550
St. Marianna University, School of Medicine
Kawasaki, Kanagawa, 2168511
Kagawa University Hospital
Kida, Kagawa-ken, 7610793
Ohta Nishinouchi Hospital
kooriyama, Fukushima, 9638558
Tokushima University Hospital
Kuramoto, Tokushima, 7708503
Kawasaki Medical University
Kurashiki, Okayama-ken, 7010192
Aizawa Hospital
Matsumoto, Nagano, 3908510
Shinshu University Hospital
Matsumoto, Nagano, 3908621
National Hospital Organization Tokyo Medical Center
Meguro City, Tokyo, 1528902
Kyorin University Hospital
Mitaka, Tokyo, 1818611
Kansai Medical University
Moriguchi, Osaka, 5708507
Iwate Medical University
Morioka, Iwate, 0208505
Musashino Red Cross Hospital
Musashino, Tokyo, 1808610
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 4600001
Nagoya University Hospital
Nagoya, Aichi-ken, 4668560
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, 6638501
Oita University Faculty of Medicine
Ōita, Oita Prefecture, 8795593
Toho University Omori Medical Center
Ōta-ku, Tokyo, 1438541
Shiga University of Medical Science
Ōtsu, Shiga, 5202192
Saga Prefectural Hospital Kouseikan
Saga, Saga-ken, 8408571
Kitasato University
Sagamihara, Kanagawa, 2288555
Sapporo Medical University
Sapporo, Hokkaido, 0608543
Showa University Hospital
Shinagawa, Tokyo, 1428666
Tokyo Medical University
Shinjuku, Tokyo, 1600023
Teikyo University Hospital
tabashi City, Tokyo, 1738606
Nihon University Itabashi Hospital
tabashi City, Tokyo, 1738610
Osaka Mishima Emergency Medical Center
Takatsuki, Osaka, 5691124
Tama Nagayama Hospital, Nippon Medical School
Tama, Tokyo, 2068512
Ehime University Hospital
Tōon, Ehime, 7910295
Fujita Health University Hospital
Toyoake, Aichi-ken, 4701192
Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital
Ube, Yamaguchi, 7558505
Saiseikai Utsunomiya Hospital
Utsunomiya, Tochigi, 3210974
Yamagata University Hospital
Yamagata, Yamagata, 9909585
Yokohama City Seibu Hospital
Yokohama, Kanagawa, 2410811
About this study
Official title: Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.
Read the detailed description
Mild hypothermia therapy shows protective effects for damaged brains of animals and post cardiac arrest patients. However, Clifton et al. reported that mild hypothermia has no protective effect for severe head trauma but has a risk of complications. In this study, all the participants must be treated with continuous monitoring of cardiac output and jugular venous oxygen saturation to get optimal physiological conditions. Adequate anesthesia such as neuroleptanesthesia is essential to maintain organ function and tissue microcirculation. Participants are randomly assigned to two groups of mild hypothermia (32.0 - 34.0 degree Celsius) and anti-hyperthermia (35.5 - 37.0 C). The body temperature must be kept for at least 72 hours. Hypothermia must be induced within 6 hours after traumatic brain injury. Glasgow outcome score at 6 months after injury and the total medical expenses of the two groups will be evaluated.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Therapeutic mild hypothermia
- Keywords
- Hypothermia, induced, Traumatic Brain injuries, Anesthesia, Neuro-intensive care, neurochemistry
- Medical subject headings
- Brain Injuries, Traumatic, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic mild hypothermiaProcedure or surgery
Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome
Glasgow outcome score and neuropsychological performance at 6 months after injury.
Measured: six months after the onset
Total medical expenses
Total medical expenses would be compared.
Measured: whole duration of treatment
Secondary outcomes (2)
Physiological data
Measured: each day during the treatment
Laboratory data
Measured: each day during the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startDec 2002
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yamaguchi University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Medical Information Network, Japan Clinical Research Support Unit(J-CRSU)
- Responsible party
- Principal investigator, Tsuyoshi Maekawa, Yamaguchi University Hospital
- Investigators
- Tsuyoshi Maekawa, MD, PhD, Principal investigator, Yamaguchi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134472
- Sponsor's protocol ID
- H14-HEART-005
- Other IDs
- H15-HEART-01, H16-HEART-01
- Status last verified
- May 2012
- First submitted
- 23 Aug 2005
- Last updated
- 11 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
- ClinicalTrials.gov ID
- NCT00134472
- Acronym / sponsor ID
- H14-HEART-005
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Hypothermia, induced, Traumatic Brain injuries, Anesthesia, Neuro-intensive care, neurochemistry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Yamaguchi University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Medical Information Network, Japan Clinical Research Support Unit(J-CRSU)
- Study start
- Dec 2002
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Aug 2005 (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 purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.
Detailed description
Mild hypothermia therapy shows protective effects for damaged brains of animals and post cardiac arrest patients. However, Clifton et al. reported that mild hypothermia has no protective effect for severe head trauma but has a risk of complications. In this study, all the participants must be treated with continuous monitoring of cardiac output and jugular venous oxygen saturation to get optimal physiological conditions. Adequate anesthesia such as neuroleptanesthesia is essential to maintain organ function and tissue microcirculation. Participants are randomly assigned to two groups of mild hypothermia (32.0 - 34.0 degree Celsius) and anti-hyperthermia (35.5 - 37.0 C). The body temperature must be kept for at least 72 hours. Hypothermia must be induced within 6 hours after traumatic brain injury. Glasgow outcome score at 6 months after injury and the total medical expenses of the two groups will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
- Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.
Key exclusion criteria (5 listed)
- Systolic blood pressure < 90mmHg (after resuscitation)
- Thrombocytopenia (platelets [Plt] < 50,000/mm3)
- Pregnancy
- Preexisting medical conditions of severe hepatic dysfunction, heart failure or any other severe organ failure
- Deep drunkenness
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 |
|---|---|---|
| Therapeutic mild hypothermiaKeeping 32 - 34 degree celsius of core temperature at least for 72 hours. | Procedure or surgery | – |
Primary outcome
Neurological outcome
Time frame: six months after the onset
Glasgow outcome score and neuropsychological performance at 6 months after injury.
Total medical expenses
Time frame: whole duration of treatment
Total medical expenses would be compared.
2 secondary outcomes
Physiological data
Time frame: each day during the treatment
Laboratory data
Time frame: each day during the treatment
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 11 May 2012.
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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.
Tsuyoshi Maekawa, MD, PhD principal investigator
Yamaguchi University Hospital
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapeutic mild hypothermia in people with Brain Injuries, Traumatic, run by Yamaguchi University Hospital at 43 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 2 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: finished, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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.
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?
Neurological outcome (time frame: six months after the onset). The study lists 2 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 11 May 2012.