Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

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

Detailed Description
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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.

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

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Procedure: Therapeutic mild hypothermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome | Glasgow outcome score and neuropsychological performance at 6 months after injury. | six months after the onset | 
| Total medical expenses | Total medical expenses would be compared. | whole duration of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological data |  | each day during the treatment | 
| Laboratory data |  | each day during the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, induced, Traumatic Brain injuries, Anesthesia, Neuro-intensive care, neurochemistry