Abstract:
Chronic subdural haematoma (CSDH) is a frequent neurological pathologic entities in daily neurosurgical practice with a rapidly rising incidence due to increasing age & wide spread use of anticoagulant. The "gold standard" of treatment is surgical evacuation by burr-hole craniostomy (BHC) for symptomatic patients but associated with complications, a recurrence rate of up to 30%, 1-year mortality rates could be as high as 32%. A complex intertwined pathway of inflammatory process, angiogenesis, local coagulopathy, recurrent microbleeds & exudates play a major role in the pathogenesis of CHDH. The objective of this study showed the effect of primary DXM therapy in treating CSDH is safe, beneficial, promising functional outcome & cost effectiveness as an alternative to BHC & surgical drainage in selected group of patients
This study is a prospective, single centre, open labeled, randomized controlled clinical trial (RCT). Consecutive patients with a CSDH with MGS grade 1-3 will be randomized to treatment with DXM therapy or BHC. The DXM protocol will be 4 mg 8 hourly either oral or i/v for 21 days, which is then slowly tapered 1 mg per day every 3 days for 4 weeks.For insufficient haematoma resolution BHC can be performed.The primary outcomes are the functional outcome by means of the mRS score at 3 months & cost effectiveness at 12 months.Secondary outcomes are QOL at 3&12 months using the SF-36 & QOL/BRI, haematoma thickness after 2 weeks on follow-up CT, haematoma recurrence during the first 12 months,complications & drug related adverse effects,failure of therapy within 12 months after randomization & intervention,mortality during first 3&12 months,duration of hospital stay & overall healthcare & productivity costs. To test non-inferiority of DXM therapy Vs BHC,finally 30 patients in DXM therapy arm & 30 patients in BHC arm are required.
The study started in June 2012; its outcomes demonstrates interesting alternatives to BHC in the management of patients harboring CSDH.
Based on pathophysiologic mechanisms & patient studies treatment with steroid play a major role in the treatment of CSDH & as effective as BHC on functional outcome,at lower costs.
