Status:
COMPLETED
Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
Lead Sponsor:
Yamaguchi University Hospital
Collaborating Sponsors:
University Hospital Medical Information Network
Japan Clinical Research Support Unit(J-CRSU)
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
15-69 years
Phase:
PHASE3
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 se...
Eligibility Criteria
Inclusion
- Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
- Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00134472
Start Date
December 1 2002
End Date
September 1 2008
Last Update
May 11 2012
Active Locations (43)
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1
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan, 4600001
2
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 4668560
3
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan, 4701192
4
Chiba University Hospital
Chiba, Chiba, Japan, 2608677