Effect of dexamethasone (DXM) therapy in patients with a brain bleed: A comparision of a non-operative treatment versus surgery on patient recovery.

INTERVENTION: Intervention arm: Patients in the intervention (DXM) arm will receive DMX in a daily dosage of 16 mg (8 mg every 12 hours) on day 1 to 4. Thereafter, DXM will be tapered down by halve every 3 days (4 mg every 12 hours on day 5 to 7, 2 mg every 12 hours on day 8 to 10, 1 mg every 12 hours on day 11 to 13, 0.5 mg every 12 hours on day 14 to 16 and 0.5 mg once a day on day 17 to 19). DXM is administered orally in tablets or intravenously when oral administration is not possible due to the clinical condition of the patient. Subjects in the DXM arm will be treated concomitantly with a proton pump inhibitor (Esomeprazole, 40 mg daily) prophylactic, during the DXM treatment regimen. Control arm: Participants randomized to the control arm will receive operative treatment by burr hole craniostomy (BHC) with insertion of a subdural drain for 48 hours (as this is standard clinical practice). The surgical procedure (BHC) will be performed according to the current in hospital neurosurgical BHC‐protocol (which is identical in all 3 participating neurosurgical hospitals). General or local anaesthesia will be applied, depending on the discretion of the treating neurosurgeon which form will be the safest. After evacuation of the hematoma in the surgical theatre, a subdural drain will be inserted for 48 hours. CONDITION: Chronic subdural hematoma, Dexamethasone ; ; PRIMARY OUTCOME: The main primary endpoint in is the functional outcome, as expressed by mRS, in both treatment arms at 3 months. SECONDARY OUTCOME: 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. 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 2) Clinical symptoms must correlate to the cerebral lesion 3) Severity of symptoms must be MGS 1‐3 4) Subject must be 18 years or older.