Brain Injuries, Traumatic
Conditions
Keywords
Hypothermia, induced, Traumatic Brain injuries, Anesthesia, Neuro-intensive care, neurochemistry
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.
Interventions
PROCEDURETherapeutic mild hypothermia
Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
Sponsors
University Hospital Medical Information Network
Japan Clinical Research Support Unit(J-CRSU)
Yamaguchi University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological outcome | six months after the onset | Glasgow outcome score and neuropsychological performance at 6 months after injury. |
| Total medical expenses | whole duration of treatment | Total medical expenses would be compared. |
Secondary
| Measure | Time frame |
|---|---|
| Physiological data | each day during the treatment |
| Laboratory data | each day during the treatment |
Countries
Japan
Outcome results
None listed