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Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00134472
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : May 11, 2012
Sponsor:
Collaborators:
University Hospital Medical Information Network
Japan Clinical Research Support Unit(J-CRSU)
Information provided by (Responsible Party):
Tsuyoshi Maekawa, Yamaguchi University Hospital

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

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Procedure: Therapeutic mild hypothermia Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
Study Start Date : December 2002
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Neurological outcome [ Time Frame: six months after the onset ]
    Glasgow outcome score and neuropsychological performance at 6 months after injury.

  2. Total medical expenses [ Time Frame: whole duration of treatment ]
    Total medical expenses would be compared.


Secondary Outcome Measures :
  1. Physiological data [ Time Frame: each day during the treatment ]
  2. Laboratory data [ Time Frame: each day during the treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134472


Locations
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Sponsors and Collaborators
Yamaguchi University Hospital
University Hospital Medical Information Network
Japan Clinical Research Support Unit(J-CRSU)
Investigators
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Principal Investigator: Tsuyoshi Maekawa, MD, PhD Yamaguchi University Hospital
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Responsible Party: Tsuyoshi Maekawa, Honorary Professor, Yamaguchi University Hospital
ClinicalTrials.gov Identifier: NCT00134472    
Other Study ID Numbers: H14-HEART-005
H15-HEART-01
H16-HEART-01
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012
Keywords provided by Tsuyoshi Maekawa, Yamaguchi University Hospital:
Hypothermia, induced
Traumatic Brain injuries
Anesthesia
Neuro-intensive care
neurochemistry
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Hypothermia
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Body Temperature Changes
Signs and Symptoms