Not Signed In -
Sports Injuries |
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Clinical Trial: Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan.
This study is currently recruiting patients.
Verified by Yamaguchi University Hospital August 2005
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Purpose
The purpose of this trial is to determine if mild hypothermia therapy for severe head trauma patients improves neurologial outcome.
| Condition | Intervention | Phase |
|---|---|---|
| Traumatic Brain Injuries | Procedure: Therapeutic mild hypothermia | Phase III |
MedlinePlus related topics: Head and Brain Injuries
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Therapeutic Strategy for Severe Head Trauma Patients with Mild Hypothermia and Estimation of Medical Expenses in Japan.
Further Study Details:
Primary Outcomes: Neurological outcome (Glasgow outcome score and neuropsychological performance at 6 month after injury); Total medical expenses
Secondary Outcomes: Physiological data; Laboratory data
Expected Total Enrollment: 300
Secondary Outcomes: Physiological data; Laboratory data
Expected Total Enrollment: 300
Study start: December 2002; Expected completion: March 2009
Last follow-up: September 2008; Data entry closure: October 2008
Mild hypothermia therapy shows protective effects for damaged brain of animals and post cardiac arrest patients. However, Clifton et al. reported that mild hypothermia has no protective effect for severe head trauma but 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 functions 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 - 69 Years, Genders Eligible for Study: Both
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:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00134472
Tsuyoshi Maekawa, MD, PhD +81-836-22-2343 tmaekawa@yamaguchi-u.ac.jp
Susumu Yamashita, MD +81-836-22-2656 sum-ygc@umin.ac.jp
Susumu Yamashita, MD +81-836-22-2656 sum-ygc@umin.ac.jp
Japan
Chiba Emergency Medical Center, Chiba, 2610012, Japan; Recruiting
Hiroshi Nakamura, MD +81-43-279-2211 nkmrh@sannet.ne.jp
Hiroshi Nakamura, MD, Principal Investigator
Hiroshi Nakamura, MD, Principal Investigator
Chiba University Hospital, Chiba, 2608677, Japan; Recruiting
Hiroyuki Hirasawa, MD +81-43-226-2341 hirasawa@ho.chiba-u.ac.jp
Hiroyuki Hirasawa, MD, Principal Investigator
Hiroyuki Hirasawa, MD, Principal Investigator
Gifu University Hospital, Gifu, 5011194, Japan; Recruiting
Shuji Dohi, MD +81-58-267-2293 shu-dohi@cc.gifu-u.ac.jp
Shuji Dohi, MD, Principal Investigator
Shuji Dohi, MD, Principal Investigator
Oita University Faculty of Medicine, Oita, 8795593, Japan; No longer recruiting
Saga Prefectural Hospital Kouseikan, Saga, 8408571, Japan; No longer recruiting
Yamagata University Hospital, Yamagata, 9909585, Japan; No longer recruiting
Japan, Aichi
Nagoya University Hospital, Nagoya, Aichi, 4668560, Japan; No longer recruiting
National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, 4600001, Japan; Recruiting
Toshio Fukuoka, MD +81-52-951-1111 toshiof@med.nagoya-u.ac.jp
Toshio Fukuoka, MD, Principal Investigator
Toshio Fukuoka, MD, Principal Investigator
Fujita Health University Hospital, Toyoake, Aichi, 4701192, Japan; Recruiting
Tetsuo Kanno, MD +81-562-93-9253 neuron@fujita-hu.ac.jp
Tetsuo Kanno, MD, Principal Investigator
Tetsuo Kanno, MD, Principal Investigator
Japan, Ehime
Ehime University Hospital, Toon, Ehime, 7910295, Japan; Recruiting
Youichi Shirakawa, MD +81-89-960-5722 sirakawa@m.ehime-u.ac.jp
Youichi Shirakawa, MD, Principal Investigator
Youichi Shirakawa, MD, Principal Investigator
Japan, Fukushima
Ohta Nishinouchi Hospital, Kooriyama, Fukushima, 9638558, Japan; Recruiting
Masahisa Kawakami, MD +81-24-925-1188 mac-k@ohta-hp.or.jp
Masahisa Kawakami, MD, Principal Investigator
Masahisa Kawakami, MD, Principal Investigator
Japan, Hokkaido
Sapporo Medical University, Sapporo, Hokkaido, 0608543, Japan; Recruiting
Yasufumi Asai, MD +81-11-611-2111 asai@sapmed.ac.jp
Yasufumi Asai, MD, Principal Investigator
Yasufumi Asai, MD, Principal Investigator
Japan, Hyogo
The Hospital of Hyogo College of Medicine, Nishinomiya, Hyogo, 6638501, Japan; Recruiting
Seishiro Marukawa, MD +81-798-45-6514 qq-maru@hyo-med.ac.jp
Seishiro Marukawa, MD, Principal Investigator
Seishiro Marukawa, MD, Principal Investigator
Japan, Ishikawa
Kanazawa University, Kanazawa, Ishikawa, 9208640, Japan; Not yet recruiting
Keiki Ogino, MD +81-76-265-2215 ogino@pub.m.kanazawa-u.ac.jp
Keiki Ogino, MD, Principal Investigator
Keiki Ogino, MD, Principal Investigator
Japan, Iwate
Iwate Medical University, Morioka, Iwate, 0208505, Japan; No longer recruiting
Japan, Kagawa
Kagawa University Hospital, Kida, Kagawa, 7610793, Japan; Recruiting
Shogo Nagao, MD +81-87-891-2207 snagao@kms.ac.jp
Yasuhiro Kuroda, MD, Sub-Investigator
Yasuhiro Kuroda, MD, Sub-Investigator
Japan, Kanagawa
Kitasato University, Sagamihara, Kanagawa, 2288555, Japan; Recruiting
Masataka Endo, MD +81-42-778-9200 masa_end@kitasato-u.ac.jp
Masataka Endo, MD, Principal Investigator
Masataka Endo, MD, Principal Investigator
St. Marianna University, School of Medicine, Kawasaki, Kanagawa, 2168511, Japan; Recruiting
Katsuya Akashi, MD +81-44-977-8111 akashi@marianna-u.ac.jp
Masahiko Uzura, MD +81-44-977-8111 muzura@marianna-u.ac.jp
Katsuya Akashi, MD, Principal Investigator
Masahiko Uzura, MD +81-44-977-8111 muzura@marianna-u.ac.jp
Katsuya Akashi, MD, Principal Investigator
Yokohama City Seibu Hospital, Yokohama, Kanagawa, 2410811, Japan; Recruiting
Yu Furuya, MD +81-45-366-1111 yufuruya@marianna-u.ac.jp
Yu Furuya, MD, Principal Investigator
Yu Furuya, MD, Principal Investigator
Japan, Nagano
Shinshu University Hospital, Matsumoto, Nagano, 3908621, Japan; No longer recruiting
Aizawa Hospital, Matsumoto, Nagano, 3908510, Japan; No longer recruiting
Japan, Nara
Nara Medical University, Kashihara, Nara, 6348522, Japan; Recruiting
Toshisuke Sakaki, MD +81-744-22-3051 neurosrg@nmu-gw.naramed-u.ac.jp
Toshisuke Sakaki, MD, Principal Investigator
Toshisuke Sakaki, MD, Principal Investigator
Japan, Okayama
Kawasaki Medical University, Kurashiki, Okayama, 7010192, Japan; No longer recruiting
Japan, Osaka
Osaka Mishima Emergency Medical Center, Takatsuki, Osaka, 5691124, Japan; Recruiting
Hitoshi Kobata, MD +81-726-83-9911 neu035@poh.osaka-med.ac.jp
Hitoshi Kobata, MD, Principal Investigator
Hitoshi Kobata, MD, Principal Investigator
Kansai Medical University, Moriguchi, Osaka, 5708507, Japan; No longer recruiting
National Hospital Organization Osaka National Hospital, Cyuo, Osaka, 5400006, Japan; No longer recruiting
Japan, Saitama
Saitama Medical Center, Kawagoe, Saitama, 3508550, Japan; No longer recruiting
Japan, Shiga
Shiga University of Medical Science, Otsu, Shiga, 5202192, Japan; No longer recruiting
Japan, Tochigi
Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, 3210974, Japan; Recruiting
Hiroshi Kagami, MD +81-28-626-5500 hiroshi_kagami@saimiya.com
Hiroshi Kagami, MD, Principal Investigator
Hiroshi Kagami, MD, Principal Investigator
Japan, Tokushima
Tokushima University Hospital, Kuramoto, Tokushima, 7708503, Japan; No longer recruiting
Japan, Tokyo
Kyorin University Hospital, Mitaka, Tokyo, 1818611, Japan; No longer recruiting
National Hospital Organization Tokyo Medical Center, Meguro, Tokyo, 1528902, Japan; Recruiting
Ryoichi Saito, MD 03-3411-0111 r-saito@muc.biglobe.ne.jp
Ryoichi Saito, MD, Sub-Investigator
Ryoichi Saito, MD, Sub-Investigator
Showa University Hospital, Shinagawa, Tokyo, 1428666, Japan; Recruiting
Toru Aruga, MD +81-3-3784-8744 aruga@med.showa-u.ac.jp
Toru Aruga, MD, Principal Investigator
Toru Aruga, MD, Principal Investigator
Teikyo University Hospital, Itabashi, Tokyo, 1738606, Japan; No longer recruiting
Tokyo Medical University, Shinjuku, Tokyo, 1600023, Japan; No longer recruiting
The University of Tokyo Hospital, Bunkyo, Tokyo, 1138655, Japan; No longer recruiting
Toho University Omori Medical Center, Ota-ku, Tokyo, 1438541, Japan; No longer recruiting
Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, 1930998, Japan; No longer recruiting
Nippon Medical School, Bunkyo, Tokyo, 1138603, Japan; Recruiting
Yasuhiro Yamamoto, MD +81-3-3822-2131 yamamtoy@nms.ac.jp
Yasuhiro Yamamoto, MD, Principal Investigator
Yasuhiro Yamamoto, MD, Principal Investigator
Tama Nagayama Hospital, Nippon Medical School, Tama, Tokyo, 2068512, Japan; Recruiting
Yasutaka Naoe, MD +81-42-376-8259 naoe@nms.ac.jp
Norifumi Ninomiya, MD, Principal Investigator
Norifumi Ninomiya, MD, Principal Investigator
Nihon University Itabashi Hospital, Itabashi, Tokyo, 1738610, Japan; Recruiting
Nariyuki Hayashi, MD +81-3-3972-8111 eccm1@med.nihon-u.ac.jp
Nariyuki Hayashi, MD, Principal Investigator
Nariyuki Hayashi, MD, Principal Investigator
Musashino Red Cross Hospital, Musashino, Tokyo, 1808610, Japan; Recruiting
Hiroki Tomita +81-422-32-3111 htomita@musashino.jrc.or.jp
Hiroki Tomita, MD, Principal Investigator
Hiroki Tomita, MD, Principal Investigator
Japan, Yamaguchi
Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital., Ube, Yamaguchi, 7558505, Japan; Recruiting
Tsuyoshi Maekawa, MD +81-836-2343 tmaekawa@yamaguchi-u.ac.jp
Susumu Yamashita, MD, Sub-Investigator
Tsuyoshi Maekawa, MD, Principal Investigator
Susumu Yamashita, MD, Sub-Investigator
Tsuyoshi Maekawa, MD, Principal Investigator
Study chairs or principal investigators
Tsuyoshi Maekawa, MD, PhD, Principal Investigator, Yamaguchi University Hospital
More Information
Study ID Numbers: H14-HEART-005; H15-HEART-01; H16-HEART-01
Last Updated: August 23, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134472
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 23, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134472
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-30
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