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Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

Primary Purpose

Brain Injuries, Traumatic

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Therapeutic mild hypothermia
Sponsored by
Yamaguchi University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic focused on measuring Hypothermia, induced, Traumatic Brain injuries, Anesthesia, Neuro-intensive care, neurochemistry

Eligibility Criteria

15 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Hospital Organization Nagoya Medical Center
  • Nagoya University Hospital
  • Fujita Health University Hospital
  • Ehime University Hospital
  • Ohta Nishinouchi Hospital
  • Sapporo Medical University
  • The Hospital of Hyogo College of Medicine
  • Kanazawa University
  • Iwate Medical University
  • Kagawa University Hospital
  • St. Marianna University, School of Medicine
  • Kitasato University
  • Yokohama City Seibu Hospital
  • Aizawa Hospital
  • Shinshu University Hospital
  • Nara Medical University
  • Kawasaki Medical University
  • National Hospital Organization Osaka National Hospital
  • Kansai Medical University
  • Osaka Mishima Emergency Medical Center
  • Saitama Medical Center
  • Shiga University of Medical Science
  • Saiseikai Utsunomiya Hospital
  • Tokushima University Hospital
  • Nippon Medical School
  • The University of Tokyo Hospital
  • Tokyo Medical University Hachioji Medical Center
  • Teikyo University Hospital
  • Nihon University Itabashi Hospital
  • National Hospital Organization Tokyo Medical Center
  • Kyorin University Hospital
  • Musashino Red Cross Hospital
  • Toho University Omori Medical Center
  • Showa University Hospital
  • Tokyo Medical University
  • Tama Nagayama Hospital, Nippon Medical School
  • Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital
  • Chiba University Hospital
  • Chiba Emergency Medical Center
  • Gifu University Hospital
  • Oita University Faculty of Medicine
  • Saga Prefectural Hospital Kouseikan
  • Yamagata University Hospital

Outcomes

Primary Outcome Measures

Neurological outcome
Glasgow outcome score and neuropsychological performance at 6 months after injury.
Total medical expenses
Total medical expenses would be compared.

Secondary Outcome Measures

Physiological data
Laboratory data

Full Information

First Posted
August 23, 2005
Last Updated
May 10, 2012
Sponsor
Yamaguchi University Hospital
Collaborators
University Hospital Medical Information Network, Japan Clinical Research Support Unit(J-CRSU)
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1. Study Identification

Unique Protocol Identification Number
NCT00134472
Brief Title
Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
Official Title
Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yamaguchi University Hospital
Collaborators
University Hospital Medical Information Network, Japan Clinical Research Support Unit(J-CRSU)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic
Keywords
Hypothermia, induced, Traumatic Brain injuries, Anesthesia, Neuro-intensive care, neurochemistry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Therapeutic mild hypothermia
Intervention Description
Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
Primary Outcome Measure Information:
Title
Neurological outcome
Description
Glasgow outcome score and neuropsychological performance at 6 months after injury.
Time Frame
six months after the onset
Title
Total medical expenses
Description
Total medical expenses would be compared.
Time Frame
whole duration of treatment
Secondary Outcome Measure Information:
Title
Physiological data
Time Frame
each day during the treatment
Title
Laboratory data
Time Frame
each day during the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsuyoshi Maekawa, MD, PhD
Organizational Affiliation
Yamaguchi University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4600001
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
4701192
Country
Japan
Facility Name
Ehime University Hospital
City
Toon
State/Province
Ehime
ZIP/Postal Code
7910295
Country
Japan
Facility Name
Ohta Nishinouchi Hospital
City
Kooriyama
State/Province
Fukushima
ZIP/Postal Code
9638558
Country
Japan
Facility Name
Sapporo Medical University
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0608543
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
6638501
Country
Japan
Facility Name
Kanazawa University
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
9208640
Country
Japan
Facility Name
Iwate Medical University
City
Morioka
State/Province
Iwate
ZIP/Postal Code
0208505
Country
Japan
Facility Name
Kagawa University Hospital
City
Kida
State/Province
Kagawa
ZIP/Postal Code
7610793
Country
Japan
Facility Name
St. Marianna University, School of Medicine
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
2168511
Country
Japan
Facility Name
Kitasato University
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
2288555
Country
Japan
Facility Name
Yokohama City Seibu Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2410811
Country
Japan
Facility Name
Aizawa Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908510
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Facility Name
Nara Medical University
City
Kashihara
State/Province
Nara
ZIP/Postal Code
6348522
Country
Japan
Facility Name
Kawasaki Medical University
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
7010192
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Cyuo
State/Province
Osaka
ZIP/Postal Code
5400006
Country
Japan
Facility Name
Kansai Medical University
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
5708507
Country
Japan
Facility Name
Osaka Mishima Emergency Medical Center
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5691124
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
3508550
Country
Japan
Facility Name
Shiga University of Medical Science
City
Otsu
State/Province
Shiga
ZIP/Postal Code
5202192
Country
Japan
Facility Name
Saiseikai Utsunomiya Hospital
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
3210974
Country
Japan
Facility Name
Tokushima University Hospital
City
Kuramoto
State/Province
Tokushima
ZIP/Postal Code
7708503
Country
Japan
Facility Name
Nippon Medical School
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
1138603
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
1138655
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
1930998
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
1738606
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
1738610
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro
State/Province
Tokyo
ZIP/Postal Code
1528902
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
1818611
Country
Japan
Facility Name
Musashino Red Cross Hospital
City
Musashino
State/Province
Tokyo
ZIP/Postal Code
1808610
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
1438541
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
1428666
Country
Japan
Facility Name
Tokyo Medical University
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
1600023
Country
Japan
Facility Name
Tama Nagayama Hospital, Nippon Medical School
City
Tama
State/Province
Tokyo
ZIP/Postal Code
2068512
Country
Japan
Facility Name
Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
7558505
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Chiba Emergency Medical Center
City
Chiba
ZIP/Postal Code
2610012
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
ZIP/Postal Code
5011194
Country
Japan
Facility Name
Oita University Faculty of Medicine
City
Oita
ZIP/Postal Code
8795593
Country
Japan
Facility Name
Saga Prefectural Hospital Kouseikan
City
Saga
ZIP/Postal Code
8408571
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
9909585
Country
Japan

12. IPD Sharing Statement

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Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

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