Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
This study has been completed.
Sponsor:
Yamaguchi University Hospital
Collaborators:
University hospital Medical Information Network(UMIN, Japan)
Japan Clinical Research Support Unit(J-CRSU)
Information provided by (Responsible Party):
Tsuyoshi Maekawa, Yamaguchi University Hospital
ClinicalTrials.gov Identifier:
NCT00134472
First received: August 23, 2005
Last updated: May 10, 2012
Last verified: May 2012
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Purpose
The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Injuries, Traumatic |
Procedure: Therapeutic mild hypothermia |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan |
Resource links provided by NLM:
Further study details as provided by Yamaguchi University Hospital:
Primary Outcome Measures:
- Neurological outcome [ Time Frame: six months after the onset ] [ Designated as safety issue: No ]Glasgow outcome score and neuropsychological performance at 6 months after injury.
- Total medical expenses [ Time Frame: whole duration of treatment ] [ Designated as safety issue: No ]Total medical expenses would be compared.
Secondary Outcome Measures:
- Physiological data [ Time Frame: each day during the treatment ] [ Designated as safety issue: No ]
- Laboratory data [ Time Frame: each day during the treatment ] [ Designated as safety issue: No ]
| Enrollment: | 150 |
| Study Start Date: | December 2002 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: Therapeutic mild hypothermia
Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
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.
Eligibility| Ages Eligible for Study: | 15 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
- Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134472
Locations
| Japan | |
| Nagoya University Hospital | |
| Nagoya, Aichi, Japan, 4668560 | |
| National Hospital Organization Nagoya Medical Center | |
| Nagoya, Aichi, Japan, 4600001 | |
| Fujita Health University Hospital | |
| Toyoake, Aichi, Japan, 4701192 | |
| Ehime University Hospital | |
| Toon, Ehime, Japan, 7910295 | |
| Ohta Nishinouchi Hospital | |
| Kooriyama, Fukushima, Japan, 9638558 | |
| Sapporo Medical University | |
| Sapporo, Hokkaido, Japan, 0608543 | |
| The Hospital of Hyogo College of Medicine | |
| Nishinomiya, Hyogo, Japan, 6638501 | |
| Kanazawa University | |
| Kanazawa, Ishikawa, Japan, 9208640 | |
| Iwate Medical University | |
| Morioka, Iwate, Japan, 0208505 | |
| Kagawa University Hospital | |
| Kida, Kagawa, Japan, 7610793 | |
| St. Marianna University, School of Medicine | |
| Kawasaki, Kanagawa, Japan, 2168511 | |
| Kitasato University | |
| Sagamihara, Kanagawa, Japan, 2288555 | |
| Yokohama City Seibu Hospital | |
| Yokohama, Kanagawa, Japan, 2410811 | |
| Aizawa Hospital | |
| Matsumoto, Nagano, Japan, 3908510 | |
| Shinshu University Hospital | |
| Matsumoto, Nagano, Japan, 3908621 | |
| Nara Medical University | |
| Kashihara, Nara, Japan, 6348522 | |
| Kawasaki Medical University | |
| Kurashiki, Okayama, Japan, 7010192 | |
| National Hospital Organization Osaka National Hospital | |
| Cyuo, Osaka, Japan, 5400006 | |
| Kansai Medical University | |
| Moriguchi, Osaka, Japan, 5708507 | |
| Osaka Mishima Emergency Medical Center | |
| Takatsuki, Osaka, Japan, 5691124 | |
| Saitama Medical Center | |
| Kawagoe, Saitama, Japan, 3508550 | |
| Shiga University of Medical Science | |
| Otsu, Shiga, Japan, 5202192 | |
| Saiseikai Utsunomiya Hospital | |
| Utsunomiya, Tochigi, Japan, 3210974 | |
| Tokushima University Hospital | |
| Kuramoto, Tokushima, Japan, 7708503 | |
| The University of Tokyo Hospital | |
| Bunkyo, Tokyo, Japan, 1138655 | |
| Nippon Medical School | |
| Bunkyo, Tokyo, Japan, 1138603 | |
| Tokyo Medical University Hachioji Medical Center | |
| Hachioji, Tokyo, Japan, 1930998 | |
| Teikyo University Hospital | |
| Itabashi, Tokyo, Japan, 1738606 | |
| Nihon University Itabashi Hospital | |
| Itabashi, Tokyo, Japan, 1738610 | |
| National Hospital Organization Tokyo Medical Center | |
| Meguro, Tokyo, Japan, 1528902 | |
| Kyorin University Hospital | |
| Mitaka, Tokyo, Japan, 1818611 | |
| Musashino Red Cross Hospital | |
| Musashino, Tokyo, Japan, 1808610 | |
| Toho University Omori Medical Center | |
| Ota-ku, Tokyo, Japan, 1438541 | |
| Showa University Hospital | |
| Shinagawa, Tokyo, Japan, 1428666 | |
| Tokyo Medical University | |
| Shinjuku, Tokyo, Japan, 1600023 | |
| Tama Nagayama Hospital, Nippon Medical School | |
| Tama, Tokyo, Japan, 2068512 | |
| Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital | |
| Ube, Yamaguchi, Japan, 7558505 | |
| Chiba Emergency Medical Center | |
| Chiba, Japan, 2610012 | |
| Chiba University Hospital | |
| Chiba, Japan, 2608677 | |
| Gifu University Hospital | |
| Gifu, Japan, 5011194 | |
| Oita University Faculty of Medicine | |
| Oita, Japan, 8795593 | |
| Saga Prefectural Hospital Kouseikan | |
| Saga, Japan, 8408571 | |
| Yamagata University Hospital | |
| Yamagata, Japan, 9909585 | |
Sponsors and Collaborators
Yamaguchi University Hospital
University hospital Medical Information Network(UMIN, Japan)
Japan Clinical Research Support Unit(J-CRSU)
Investigators
| Principal Investigator: | Tsuyoshi Maekawa, MD, PhD | Yamaguchi University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Tsuyoshi Maekawa, Honorary Professor, Yamaguchi University Hospital |
| ClinicalTrials.gov Identifier: | NCT00134472 History of Changes |
| Other Study ID Numbers: | H14-HEART-005, H15-HEART-01, H16-HEART-01 |
| Study First Received: | August 23, 2005 |
| Last Updated: | May 10, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Yamaguchi University Hospital:
|
Hypothermia, induced Traumatic Brain injuries Anesthesia Neuro-intensive care neurochemistry |
Additional relevant MeSH terms:
|
Hypothermia Brain Injuries Body Temperature Changes Signs and Symptoms Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on October 16, 2012
