Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

NCT ID: NCT00134472

Last Updated: 2012-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2008-09-30

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.

Conditions

Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Therapeutic mild hypothermia

Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Medical Information Network

OTHER

Sponsor Role: collaborator

Japan Clinical Research Support Unit(J-CRSU)

UNKNOWN

Sponsor Role: collaborator

Yamaguchi University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tsuyoshi Maekawa

Honorary Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tsuyoshi Maekawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yamaguchi University Hospital

Locations

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Chiba University Hospital

Chiba, Chiba, Japan

Chiba Emergency Medical Center

Chiba, Chiba, Japan

Ehime University Hospital

Tōon, Ehime, Japan

Ohta Nishinouchi Hospital

kooriyama, Fukushima, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Sapporo Medical University

Sapporo, Hokkaido, Japan

The Hospital of Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

Kanazawa University

Kanazawa, Ishikawa-ken, Japan

Iwate Medical University

Morioka, Iwate, Japan

Kagawa University Hospital

Kida, Kagawa-ken, 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

Oita University Faculty of Medicine

Ōita, Oita Prefecture, Japan

Kawasaki Medical University

Kurashiki, Okayama-ken, Japan

National Hospital Organization Osaka National Hospital

Cyuo, Osaka, Japan

Kansai Medical University

Moriguchi, Osaka, Japan

Osaka Mishima Emergency Medical Center

Takatsuki, Osaka, Japan

Saga Prefectural Hospital Kouseikan

Saga, Saga-ken, Japan

Saitama Medical Center

Kawagoe, Saitama, Japan

Shiga University of Medical Science

Ōtsu, Shiga, Japan

Saiseikai Utsunomiya Hospital

Utsunomiya, Tochigi, Japan

Tokushima University Hospital

Kuramoto, Tokushima, Japan

Nippon Medical School

Bunkyo, Tokyo, Japan

The University of Tokyo Hospital

Bunkyo, Tokyo, Japan

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, Japan

National Hospital Organization Tokyo Medical Center

Meguro City, Tokyo, Japan

Kyorin University Hospital

Mitaka, Tokyo, Japan

Musashino Red Cross Hospital

Musashino, Tokyo, Japan

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Showa University Hospital

Shinagawa, Tokyo, Japan

Tokyo Medical University

Shinjuku, Tokyo, Japan

Teikyo University Hospital

tabashi City, Tokyo, Japan

Nihon University Itabashi Hospital

tabashi City, Tokyo, Japan

Tama Nagayama Hospital, Nippon Medical School

Tama, Tokyo, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan

Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Countries

Japan

Other Identifiers

H15-HEART-01

Identifier Type: -

Identifier Source: secondary_id

H16-HEART-01

Identifier Type: -

Identifier Source: secondary_id

H14-HEART-005

Identifier Type: -

Identifier Source: org_study_id