Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan

The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.

Study Overview

• Status: Completed
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Procedure: Therapeutic mild hypothermia

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
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan, 2608677
    • Chiba University Hospital
  • Chiba, Japan, 2610012
    • Chiba Emergency Medical Center
  • Gifu, Japan, 5011194
    • Gifu University Hospital
  • Oita, Japan, 8795593
    • Oita University Faculty of Medicine
  • Saga, Japan, 8408571
    • Saga Prefectural Hospital Kouseikan
  • Yamagata, Japan, 9909585
    • Yamagata University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 4600001
      • National Hospital Organization Nagoya Medical Center
    • Nagoya, Aichi, Japan, 4668560
      • Nagoya University Hospital
    • Toyoake, Aichi, Japan, 4701192
      • Fujita Health University Hospital
  • Ehime
    • Toon, Ehime, Japan, 7910295
      • Ehime University Hospital
  • Fukushima
    • Kooriyama, Fukushima, Japan, 9638558
      • Ohta Nishinouchi Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0608543
      • Sapporo Medical University
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 6638501
      • The Hospital of Hyogo College of Medicine
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 9208640
      • Kanazawa University
  • Iwate
    • Morioka, Iwate, Japan, 0208505
      • Iwate Medical University
  • Kagawa
    • Kida, Kagawa, Japan, 7610793
      • Kagawa University Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 2168511
      • St. Marianna University, School of Medicine
    • Sagamihara, Kanagawa, Japan, 2288555
      • Kitasato University
    • Yokohama, Kanagawa, Japan, 2410811
      • Yokohama City Seibu Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 3908621
      • Shinshu University Hospital
    • Matsumoto, Nagano, Japan, 3908510
      • Aizawa Hospital
  • Nara
    • Kashihara, Nara, Japan, 6348522
      • Nara Medical University
  • Okayama
    • Kurashiki, Okayama, Japan, 7010192
      • Kawasaki Medical University
  • Osaka
    • Cyuo, Osaka, Japan, 5400006
      • National Hospital Organization Osaka National Hospital
    • Moriguchi, Osaka, Japan, 5708507
      • Kansai Medical University
    • Takatsuki, Osaka, Japan, 5691124
      • Osaka Mishima Emergency Medical Center
  • Saitama
    • Kawagoe, Saitama, Japan, 3508550
      • Saitama Medical Center
  • Shiga
    • Otsu, Shiga, Japan, 5202192
      • Shiga University of Medical Science
  • Tochigi
    • Utsunomiya, Tochigi, Japan, 3210974
      • Saiseikai Utsunomiya Hospital
  • Tokushima
    • Kuramoto, Tokushima, Japan, 7708503
      • Tokushima University Hospital
  • Tokyo
    • Bunkyo, Tokyo, Japan, 1138603
      • Nippon Medical School
    • Bunkyo, Tokyo, Japan, 1138655
      • The University of Tokyo Hospital
    • Hachioji, Tokyo, Japan, 1930998
      • Tokyo Medical University Hachioji Medical Center
    • Itabashi, Tokyo, Japan, 1738606
      • Teikyo University Hospital
    • Itabashi, Tokyo, Japan, 1738610
      • Nihon University Itabashi Hospital
    • Meguro, Tokyo, Japan, 1528902
      • National Hospital Organization Tokyo Medical Center
    • Mitaka, Tokyo, Japan, 1818611
      • Kyorin University Hospital
    • Musashino, Tokyo, Japan, 1808610
      • Musashino Red Cross Hospital
    • Ota-ku, Tokyo, Japan, 1438541
      • Toho University Omori Medical Center
    • Shinagawa, Tokyo, Japan, 1428666
      • Showa University Hospital
    • Shinjuku, Tokyo, Japan, 1600023
      • Tokyo Medical University
    • Tama, Tokyo, Japan, 2068512
      • Tama Nagayama Hospital, Nippon Medical School
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 7558505
      • Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 69 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological outcome	Glasgow outcome score and neuropsychological performance at 6 months after injury.	six months after the onset
Total medical expenses	Total medical expenses would be compared.	whole duration of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Physiological data	each day during the treatment
Laboratory data	each day during the treatment

Collaborators and Investigators

• Sponsor: Yamaguchi University Hospital
• Collaborators: University Hospital Medical Information Network; Japan Clinical Research Support Unit(J-CRSU)
• Investigators: Principal Investigator: Tsuyoshi Maekawa, MD, PhD, Yamaguchi University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (ACTUAL): September 1, 2008
• Study Completion (ACTUAL): September 1, 2008

Study Registration Dates

• First Submitted: August 23, 2005
• First Submitted That Met QC Criteria: August 23, 2005
• First Posted (ESTIMATE): August 24, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): May 11, 2012
• Last Update Submitted That Met QC Criteria: May 10, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Anesthesia; neurochemistry; Hypothermia, induced; Traumatic Brain injuries; Neuro-intensive care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Body Temperature Changes; Brain Injuries; Brain Injuries, Traumatic; Hypothermia
• Other Study ID Numbers: H14-HEART-005; H15-HEART-01; H16-HEART-01