European Society of Intensive Care Medicine study of therapeutic hypothermia (32-35 degrees Celsius) for ICP reduction after traumatic brain injury

Phase 3

Completed

Conditions: brain concussion
brain injury
10021666

Registration Number: NL-OMON38267

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1.18 years of age or older 2.primary closed traumatic brain injury 3.raised ICP>20mmHg 4. up to 10 days after initial head injury 5.cooling device or technique available for at least 48 hours 6.core temperature 36 degrees Celsius or higher at the time of randomisation 7.abnormal CT of the brain

Exclusion Criteria

1.already receiving therapeutic hypothermia 2.barbiturate therapy prior to inclusion 3.unlikely to survive in next 24 hours according to ICU consultant or neurosurgeon 4.temperature 34 degrees or less at admission 5.pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>outcome at 6 months using the extended Glasgow Outcome Scale (GOSE)<br /><br>questionnaire</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>6 month mortality rate, intracranial pressure control, incidence of pneumonia,<br /><br>length of stay in hospital and ICU, Modified Oxford Handicap Scale score at one<br /><br>month, discharge from randomising hospital or death whichever occurs first,<br /><br>correlation betweenpredicted outcome using mOxford Handicap Scale at discharge<br /><br>from hospital and the GOSE Score at 6 months and health economics</p><br>