Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134472
• Other study ID #: H14-HEART-005
• Secondary ID: H15-HEART-01H16-
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2005
• Last updated: May 10, 2012
• Start date: December 2002
• Est. completion date: September 2008

Study information

• Verified date: May 2012
• Source: Yamaguchi University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hypothermia

Intervention

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

Locations

Country	Name	City	State
Japan	Nippon Medical School	Bunkyo	Tokyo
Japan	The University of Tokyo Hospital	Bunkyo	Tokyo
Japan	Chiba Emergency Medical Center	Chiba
Japan	Chiba University Hospital	Chiba
Japan	National Hospital Organization Osaka National Hospital	Cyuo	Osaka
Japan	Gifu University Hospital	Gifu
Japan	Tokyo Medical University Hachioji Medical Center	Hachioji	Tokyo
Japan	Nihon University Itabashi Hospital	Itabashi	Tokyo
Japan	Teikyo University Hospital	Itabashi	Tokyo
Japan	Kanazawa University	Kanazawa	Ishikawa
Japan	Nara Medical University	Kashihara	Nara
Japan	Saitama Medical Center	Kawagoe	Saitama
Japan	St. Marianna University, School of Medicine	Kawasaki	Kanagawa
Japan	Kagawa University Hospital	Kida	Kagawa
Japan	Ohta Nishinouchi Hospital	Kooriyama	Fukushima
Japan	Tokushima University Hospital	Kuramoto	Tokushima
Japan	Kawasaki Medical University	Kurashiki	Okayama
Japan	Aizawa Hospital	Matsumoto	Nagano
Japan	Shinshu University Hospital	Matsumoto	Nagano
Japan	National Hospital Organization Tokyo Medical Center	Meguro	Tokyo
Japan	Kyorin University Hospital	Mitaka	Tokyo
Japan	Kansai Medical University	Moriguchi	Osaka
Japan	Iwate Medical University	Morioka	Iwate
Japan	Musashino Red Cross Hospital	Musashino	Tokyo
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	The Hospital of Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Oita University Faculty of Medicine	Oita
Japan	Toho University Omori Medical Center	Ota-ku	Tokyo
Japan	Shiga University of Medical Science	Otsu	Shiga
Japan	Saga Prefectural Hospital Kouseikan	Saga
Japan	Kitasato University	Sagamihara	Kanagawa
Japan	Sapporo Medical University	Sapporo	Hokkaido
Japan	Showa University Hospital	Shinagawa	Tokyo
Japan	Tokyo Medical University	Shinjuku	Tokyo
Japan	Osaka Mishima Emergency Medical Center	Takatsuki	Osaka
Japan	Tama Nagayama Hospital, Nippon Medical School	Tama	Tokyo
Japan	Ehime University Hospital	Toon	Ehime
Japan	Fujita Health University Hospital	Toyoake	Aichi
Japan	Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital	Ube	Yamaguchi
Japan	Saiseikai Utsunomiya Hospital	Utsunomiya	Tochigi
Japan	Yamagata University Hospital	Yamagata
Japan	Yokohama City Seibu Hospital	Yokohama	Kanagawa

Sponsors (3)

Lead Sponsor	Collaborator
Yamaguchi University Hospital	Japan Clinical Research Support Unit(J-CRSU), University Hospital Medical Information Network

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological outcome	Glasgow outcome score and neuropsychological performance at 6 months after injury.	six months after the onset	No
Primary	Total medical expenses	Total medical expenses would be compared.	whole duration of treatment	No
Secondary	Physiological data		each day during the treatment	No
Secondary	Laboratory data		each day during the treatment	No

External Links

•   BHYPO: Brain Hypothermia therapy for acute head injury