Clinical trial NCT00134472: Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
Official title: Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Injuries, Traumatic
Keywords: Hypothermia, induced
Traumatic Brain injuries
Anesthesia
Neuro-intensive care
neurochemistry
Lead sponsor: Yamaguchi University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Medical Information Network
name: Japan Clinical Research Support Unit(J-CRSU)
First posted: 2005-08-24
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Neurological outcome
timeFrame: six months after the onset
measure: Total medical expenses
timeFrame: whole duration of treatment
Secondary outcomes:
measure: Physiological data
timeFrame: each day during the treatment
measure: Laboratory data
timeFrame: each day during the treatment
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Kooriyama
country: Japan
facility: Ohta Nishinouchi Hospital
state: Fukushima
city: Sapporo
country: Japan
facility: Sapporo Medical University
state: Hokkaido
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Medical University
state: Iwate
city: Kida
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Kawasaki
country: Japan
facility: St. Marianna University, School of Medicine
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City Seibu Hospital
state: Kanagawa
city: Matsumoto
country: Japan
facility: Aizawa Hospital
state: Nagano
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Kashihara
country: Japan
facility: Nara Medical University
state: Nara
city: Kurashiki
country: Japan
facility: Kawasaki Medical University
state: Okayama
city: Cyuo
country: Japan
facility: National Hospital Organization Osaka National Hospital
state: Osaka
city: Moriguchi
country: Japan
facility: Kansai Medical University
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Mishima Emergency Medical Center
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Otsu
country: Japan
facility: Shiga University of Medical Science
state: Shiga
city: Utsunomiya
country: Japan
facility: Saiseikai Utsunomiya Hospital
state: Tochigi
city: Kuramoto
country: Japan
facility: Tokushima University Hospital
state: Tokushima
city: Bunkyo
country: Japan
facility: Nippon Medical School
state: Tokyo
city: Bunkyo
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
state: Tokyo
city: Itabashi
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Itabashi
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Meguro
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Musashino
country: Japan
facility: Musashino Red Cross Hospital
state: Tokyo
city: Ota-ku
country: Japan
facility: Toho University Omori Medical Center
state: Tokyo
city: Shinagawa
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University
state: Tokyo
city: Tama
country: Japan
facility: Tama Nagayama Hospital, Nippon Medical School
state: Tokyo
city: Ube
country: Japan
facility: Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: Chiba Emergency Medical Center
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Oita
country: Japan
facility: Oita University Faculty of Medicine
city: Saga
country: Japan
facility: Saga Prefectural Hospital Kouseikan
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Yamaguchi University Hospital
name: Tsuyoshi Maekawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: