Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
- Conditions
- Brain Injuries, Traumatic
- Registration Number
- NCT00134472
- Lead Sponsor
- Yamaguchi University Hospital
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
- Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Neurological outcome six months after the onset Glasgow outcome score and neuropsychological performance at 6 months after injury.
Total medical expenses whole duration of treatment Total medical expenses would be compared.
- Secondary Outcome Measures
Name Time Method Laboratory data each day during the treatment Physiological data each day during the treatment
Trial Locations
- Locations (43)
The Hospital of Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Fujita Health University Hospital
🇯🇵Toyoake, Aichi, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Sapporo Medical University
🇯🇵Sapporo, Hokkaido, Japan
Ohta Nishinouchi Hospital
🇯🇵Kooriyama, Fukushima, Japan
Kanazawa University
🇯🇵Kanazawa, Ishikawa, Japan
Iwate Medical University
🇯🇵Morioka, Iwate, Japan
Kagawa University Hospital
🇯🇵Kida, Kagawa, Japan
St. Marianna University, School of Medicine
🇯🇵Kawasaki, Kanagawa, Japan
Kitasato University
🇯🇵Sagamihara, Kanagawa, Japan
Yokohama City Seibu Hospital
🇯🇵Yokohama, Kanagawa, Japan
Aizawa Hospital
🇯🇵Matsumoto, Nagano, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Nagano, Japan
Nara Medical University
🇯🇵Kashihara, Nara, Japan
Kawasaki Medical University
🇯🇵Kurashiki, Okayama, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Cyuo, Osaka, Japan
Kansai Medical University
🇯🇵Moriguchi, Osaka, Japan
Saitama Medical Center
🇯🇵Kawagoe, Saitama, Japan
Shiga University of Medical Science
🇯🇵Otsu, Shiga, Japan
Saiseikai Utsunomiya Hospital
🇯🇵Utsunomiya, Tochigi, Japan
Tokushima University Hospital
🇯🇵Kuramoto, Tokushima, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo, Tokyo, Japan
Nippon Medical School
🇯🇵Bunkyo, Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Hachioji, Tokyo, Japan
Teikyo University Hospital
🇯🇵Itabashi, Tokyo, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashi, Tokyo, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro, Tokyo, Japan
Kyorin University Hospital
🇯🇵Mitaka, Tokyo, Japan
Musashino Red Cross Hospital
🇯🇵Musashino, Tokyo, Japan
Toho University Omori Medical Center
🇯🇵Ota-ku, Tokyo, Japan
Showa University Hospital
🇯🇵Shinagawa, Tokyo, Japan
Tokyo Medical University
🇯🇵Shinjuku, Tokyo, Japan
Tama Nagayama Hospital, Nippon Medical School
🇯🇵Tama, Tokyo, Japan
Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Chiba Emergency Medical Center
🇯🇵Chiba, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Oita University Faculty of Medicine
🇯🇵Oita, Japan
Saga Prefectural Hospital Kouseikan
🇯🇵Saga, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Aichi, Japan
Osaka Mishima Emergency Medical Center
🇯🇵Takatsuki, Osaka, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan