Effect of dexamethasone (DXM) therapy in patients with a brain bleed: A comparision of a non-operative treatment versus surgery on patient recovery.
Recruiting
- Conditions
- EN: Chronic subdural hematoma, CSDH, dexamethasone, DXMNL: Chronisch subduraal hematoom, dexamethason
- Registration Number
- NL-OMON21208
- Lead Sponsor
- Department of Neurosurgery and NeurologyHaaglanden Medical Centre, The Hague
- Brief Summary
In preparation: Manuscript regarding protocol publication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 170
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1) Presence of a chronic subdural haematoma
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1) an acute subdural haematoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main primary endpoint in is the functional outcome, as expressed by mRS, in both treatment arms at 3 months.
- Secondary Outcome Measures
Name Time Method Secondary outcomes include: clinical outcome at discharge, 2 weeks and at 6 months (expressed by mRS and MGS), the number of surgical intervention prevented in the DXM group, quality of life (as expressed by the Short Form – 36 Health Survey, SF-36) at 6 months, haematoma thickness after 2 weeks, haematoma recurrence (defined as recurrence of symptoms and neurological signs after initial improvement with persistence, recurrence or increase of CSDH on follow up cranial CT) during the first 6 months, complications and drug related adverse events, mortality, duration of hospital stay and health care costs in both subject groups.