Revised Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH study) Survival and quality of life after early surgical intervention versus wait-and-see in elderly patients with a traumatic acute subdural hematoma (ASDH): an international multicenter prospective cohort study

Conditions: 10007963
Traumatic acuut subdural hematoma / Traumatic intracranial bleeding
10009720
10047075

Registration Number: NL-OMON52833

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 300

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

- 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Functional outcome after 1 year, expressed by the rating on the Extended<br /><br>Glasgow Outcome Scale (GOS-E)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Functional outcome as expressed on the GOS-E besides the one year measurement<br /><br>(this includes mortality)<br /><br>- Disease-specific quality of life as expressed on the QOLIBRI<br /><br>- Health-related quality of life as expressed on the EuroQol-5D-5L<br /><br>- Cognitive functioning as expressed on the MOCA<br /><br>- Direct & indirect costs<br /><br>- Duration of hospital stay<br /><br>- Time from event to surgery<br /><br>- Discharge locations<br /><br>- Complications (during hospital stay)<br /><br>- Secondary surgery in both groups</p><br>