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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


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
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