Therapeutic Strategy for Severe Head Trauma Patients with Mild Hypothermia and Estimation of Medical Expenses in Japan.

UMIN ID: C000000231

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Traumatic Brain Injuries
• Date of first enrollment: 2002/12/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Mild hypothermia therapy ( 32.0 – 34.0 degree Celsius)
Anti-hyperthermia therapy ( 35.5 – 37.0 C )

Outcome(s)

• Primary Outcome: Neurological outcome (Glasgow outcome score and neuropsychological performance at 6 month after injury); Total medical expenses
• Secondary Outcome: Physiological data; Laboratory data

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Systolic blood pressure <90mmHg ( after resuscitation ) Thrombocytopenia ( Plt<50,000/mm3 ) pregnancy preexisting medical conditions of severe hepatic dysfunction, heart failure or any other severe organ failure deep drunkenness

Related Information

• Primary Sponsor: BHYPO Group
• Secondary Sponsor: University hospital Medical Information Network(UMIN, Japan) Japan Clinical Research Support Unit(J-CRSU)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare (JAPAN)
• Secondary ID(s): NCT00134472