Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 150
- Locations
- 43
- Primary Endpoint
- Neurological outcome
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 69 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Neurological outcome
Time Frame: six months after the onset
Glasgow outcome score and neuropsychological performance at 6 months after injury.
Total medical expenses
Time Frame: whole duration of treatment
Total medical expenses would be compared.
Secondary Outcomes
- Laboratory data(each day during the treatment)
- Physiological data(each day during the treatment)
Investigators
Tsuyoshi Maekawa
Honorary Professor
Yamaguchi University Hospital