Dexamethasone (DXM) therapy in symptomatic patients with chronic subdural hematoma (DECSA– Trial). Effect of initial corticosteroid therapy versus primary surgery on clinical outcome.

INTERVENTION: Trade Name: Dexamethasone (generic: i.e. Apotex, Centrafarm, Teva) Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE CAS Number: 50‐02‐2 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 0,5‐4 CONDITION: Chronic subdural hematoma. ; MedDRA version: 18.1 Level: LLT Classification code 10049163 Term: Chronic subdural hematoma System Organ Class: 100000004863 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To compare the effect of initial dexamethasone therapy compared to primary surgery on functional outcome (as expressed by the modified Rankin Score, mRS) in patients with a chronic subdural hematoma after 3 months. Primary end point(s): The functional outcome (as expressed by the modified Rankin Scale, mRS) in patients with a chronic subdural hematoma. Secondary Objective: To compare other variables in both subject groups (dexamethasone versus surgery), such as: ; ‐ Clinical outcome at discharge, 2 weeks and 6 months (expressed by mRS and Markwalder Grading Score, MGS).; ‐ Number of surgical intervention prevented in intervention (DXM) group. ; ‐ Quality of life (as expressed by Short Form (36) Health Survey, at 6 months).; ‐ Haematoma thickness (after 2 weeks). ; ‐ Haematoma recurrence: Recurrence of symptoms and neurological sign after initial improvement with persistence, recurrence or increase of CSDH on CT‐scan (within the first 6 months).; ‐ Complications (during hospital stay and DXM therapy).; ‐ Mortality (within the first 3 months).; ‐ Drug related adverse events.; ‐ Duration of hospital stay. ; ‐ Costs.; Timepoint(s) of evaluation of this end point: After 3 months. SECONDARY OUTCOME: Secondary end point(s): Secondary Objectives: ; ‐ Clinical outcome at discharge, 2 weeks and 6 months (expressed by mRS and Markwalder Grading Score, MGS). ; ‐ Number of surgical intervention prevented in intervention (DXM) group. ; ‐ Quality of life (as expressed by Short Form (36) Health Survey, at 6 months). ; ‐ Haematoma thickness (after 2 weeks). ; ‐ Haematoma recurrence: Recurrence of symptoms and neurological sign after initial improvement with persistence, recurrence or increase of CSDH on CT‐scan (within the first 6 months). ; ‐ Complications (during hospital stay and DXM therapy). ; ‐ Mortality (within the first 3 months). ; ‐ Drug related adverse events. ; ‐ Duration of hospital stay. ; ‐ Costs. ; Timepoint(s) of evaluation of this end point: As specified in E5.2 INCLUSION CRITERIA: In order to be eligible to participate in this study, a subject must meet all of the following criteria: ‐ Presence of a chronic subdural hematoma: An isodens or hypodens hematoma on cranial CT‐scan. Hyperdens components may be present but must compromise less than 1/3 of the hematoma. ‐ Clinical symptoms must correlate to the cerebral lesion. ‐ Severity of symptoms must be Marwalder Grading Score 1‐3. ‐ Subject must be 18 years or older. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85