Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma
- Conditions
- Traumatic Brain Injury, Acute Subdural Hematoma
- Registration Number
- NL-OMON27007
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Age = 65 years
-A GCS of = 9 and a traumatic ASDH >10 mm in diameter or a traumatic ASDH <10 mm but with a midline shift >5 mm, or a GCS <9 and a traumatic ASDH <10 mm and a midline shift <5 mm without extracranial explanations for the comatose condition
-Clinical equipoise exists (i.e. the responsible neurosurgeon is uncertain about the benefits of either treatment)
-Informed consent is obtained or deferred
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the effect of early surgical hematoma evacuation compared to conservative treatment on functional outcome (as expressed by the GOS-E) after 1 year in elderly patients with a traumatic ASDH.
- Secondary Outcome Measures
Name Time Method -Functional outcome as expressed on the GOS-E besides the one year measurement (this includes mortality)<br>-Disease-specific quality of life as expressed on the QOLIBRI <br>-Health-related quality of life as expressed on the EuroQol-5D-5L<br>-Cognitive functioning as expressed on the MOCA<br>-Direct & indirect costs<br>-Duration of hospital stay<br>-Time from event to surgery<br>-Discharge locations<br>-Complications (during hospital stay)<br>-Secondary surgery in both groups