brain concussion brain injury
Conditions
Interventions
Therapeutic hypothermia between 32 and 35 degrees Celsius to lower ICP to below
20 mmHg
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| outcome at 6 months using the extended Glasgow Outcome Scale (GOSE) questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 month mortality rate, intracranial pressure control, incidence of pneumonia, length of stay in hospital and ICU, Modified Oxford Handicap Scale score at one month, discharge from randomising hospital or death whichever occurs first, correlation betweenpredicted outcome using mOxford Handicap Scale at discharge from hospital and the GOSE Score at 6 months and health economics | — |
Countries
Netherlands
Outcome results
None listed