Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

This study has been completed.
Sponsor:
Collaborators:
University hospital Medical Information Network(UMIN, Japan)
Japan Clinical Research Support Unit(J-CRSU)
Information provided by (Responsible Party):
Tsuyoshi Maekawa, Yamaguchi University Hospital
ClinicalTrials.gov Identifier:
NCT00134472
First received: August 23, 2005
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Brain Injuries, Traumatic
Procedure: Therapeutic mild hypothermia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan

Resource links provided by NLM:


Further study details as provided by Yamaguchi University Hospital:

Primary Outcome Measures:
  • Neurological outcome [ Time Frame: six months after the onset ] [ Designated as safety issue: No ]
    Glasgow outcome score and neuropsychological performance at 6 months after injury.

  • Total medical expenses [ Time Frame: whole duration of treatment ] [ Designated as safety issue: No ]
    Total medical expenses would be compared.


Secondary Outcome Measures:
  • Physiological data [ Time Frame: each day during the treatment ] [ Designated as safety issue: No ]
  • Laboratory data [ Time Frame: each day during the treatment ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: December 2002
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Therapeutic mild hypothermia
    Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
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

Ages Eligible for Study:   15 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134472

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

Additional Information:
No publications provided

Responsible Party: Tsuyoshi Maekawa, Honorary Professor, Yamaguchi University Hospital
ClinicalTrials.gov Identifier: NCT00134472     History of Changes
Other Study ID Numbers: H14-HEART-005, H15-HEART-01, H16-HEART-01
Study First Received: August 23, 2005
Last Updated: May 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on April 17, 2014