CompletedPhase 3

Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

Japan150 participantsStarted 2002-12

Plain-language summary

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

Who can participate

Age range15 Years – 69 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Neurological outcome

Timeframe: six months after the onset

Total medical expenses

Timeframe: whole duration of treatment

Trial details

NCT IDNCT00134472

SponsorYamaguchi University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-09

View on ClinicalTrials.gov More Brain Injuries, Traumatic trials