Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00134472
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : May 11, 2012
University Hospital Medical Information Network
Japan Clinical Research Support Unit(J-CRSU)
Information provided by (Responsible Party):
Tsuyoshi Maekawa, 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.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Procedure: Therapeutic mild hypothermia Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
Study Start Date : December 2002
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: Therapeutic mild hypothermia
    Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.

Primary Outcome Measures :
  1. Neurological outcome [ Time Frame: six months after the onset ]
    Glasgow outcome score and neuropsychological performance at 6 months after injury.

  2. Total medical expenses [ Time Frame: whole duration of treatment ]
    Total medical expenses would be compared.

Secondary Outcome Measures :
  1. Physiological data [ Time Frame: each day during the treatment ]
  2. Laboratory data [ Time Frame: each day during the treatment ]

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Ages Eligible for Study:   15 Years to 69 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00134472

National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan, 4600001
Nagoya University Hospital
Nagoya, Aichi, Japan, 4668560
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
Nippon Medical School
Bunkyo, Tokyo, Japan, 1138603
The University of Tokyo Hospital
Bunkyo, Tokyo, Japan, 1138655
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 University Hospital
Chiba, Japan, 2608677
Chiba Emergency Medical Center
Chiba, Japan, 2610012
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
Japan Clinical Research Support Unit(J-CRSU)
Principal Investigator: Tsuyoshi Maekawa, MD, PhD Yamaguchi University Hospital

Responsible Party: Tsuyoshi Maekawa, Honorary Professor, Yamaguchi University Hospital Identifier: NCT00134472     History of Changes
Other Study ID Numbers: H14-HEART-005
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012

Keywords provided by Tsuyoshi Maekawa, Yamaguchi University Hospital:
Hypothermia, induced
Traumatic Brain injuries
Neuro-intensive care

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Body Temperature Changes
Signs and Symptoms