Objectives. To determine the clinical efficacy and cost-effectiveness of a short course of dexamethasone in symptomatic patients with chronic subdural hematoma (CSDH). Design. UK-wide multi-centre, pragmatic, randomised, double-blind placebo-controlled trial. Subjects. All adults (>16) with symptomatic CSDH on cranial imaging will be eligible for inclusion. Exclusion criteria include patients already on steroids, patients with clear contraindications and CSDH in the context of a CSF shunt. Patients will have to be enrolled and randomised within 72h of admission to the neurosurgical unit. Methods. Patients will be randomised to either dexamethasone or placebo with a 1:1 allocation. The rest of the treatment pathway will remain unchanged and the decision of whether or not to intervene surgically, the timing and choice of operation will remain with the responsible neurosurgical team, who will be blinded to the allocation. We aim to randomise 750 patients over 3 years, with an initial pilot phase of 1 year (100 patients) and a substantive phase of 2 years (650 patients). Results. The primary outcome measure will be the modified Rankin Scale (mRS) at 6 months and secondary outcome measures will include the rates of surgical intervention, length of stay, quality of life, cognitive assessments, mortality, complications and health-economic analyses. Conclusions. This multi-centre randomised trial will provide level-1 evidence as to the effectiveness of dexamethasone in improving functional outcome in patients with CSDH. TP1-1: Dex-CSDH trial: a randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic Chronic Subdural Haematoma | Request PDF. Available from: https://www.researchgate.net/publication/277332721_TP1-1_Dex-CSDH_trial_a_randomised_double_blind_placebo-controlled_trial_of_a_two-week_course_of_dexamethasone_for_adult_patients_with_a_symptomatic_Chronic_Subdural_Haematoma [accessed Sep 17 2018].
|Number of pages||163|
|Publication status||Published - Apr 2015|