Traumatic acuut subdural hematoma / Traumatic intracranial bleeding
Conditions
Interventions
Patients are randomized to either early surgical hematoma evacuation (A) or
conservative management on the ICU or the ward (B). In case of neurological
deterioration during conservative management,
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 55 years - History of traumatic brain injury - Acute subdural hematoma >10mm and/or with a midline shift* >5mm on radiological imaging (CT-scan) * Midline shift will be measured as the perpendicular distance between the septum pellucidum and a line designated the midline on CT-scan in brain setting.
Exclusion criteria
Exclusion criteria: - Additional epidural hematoma (EDH) or infratentorial (e.g. cerebellar) intracerebral hemorrhage (ICH) - Major traumatic abdominal or thoracic injury (each separately defined as an Abbreviated Injury Scale (AIS) score >= 4) or a *moribund* state at presentation (e.g. bilaterally absent pupillary responses) - Known terminal condition resulting in a life expectancy of less than 1 year - Severe and progressive dementia or cerebral infarction necessitating daily care in a nursery home in the pre-trauma period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome after 1 year, expressed by the rating on the Extended Glasgow Outcome Scale (GOS-E) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Functional outcome as expressed on the GOS-E besides the one year measurement (this includes mortality) - Disease-specific quality of life as expressed on the QOLIBRI - Health-related quality of life as expressed on the EuroQol-5D-5L - Cognitive functioning as expressed on the MOCA - Direct & indirect costs - Duration of hospital stay - Time from event to surgery - Discharge locations - Complications (during hospital stay) - Secondary surgery in both groups | — |
Countries
Netherlands
Outcome results
None listed