Dexamethasone therapy versus surgery for chronic subdural haematoma (DECSA trial): study protocol for a randomised controlled trial

Abstract

BackgroundChronic subdural haematoma (CSDH) is a common neurological disease with a rapidly rising incidence due to increasing age and widespread use of anticoagulants. Surgical intervention by burr-hole craniotomy (BHC) is the current standard practice for symptomatic patients, but associated with complications, a recurrence rate of up to 30% and increased mortality. Dexamethasone (DXM) therapy is, therefore, used as a non-surgical alternative but considered to achieve a lower success rate. Furthermore, the benefit of DXM therapy appears much more deliberate than the immediate relief from BHC. Lack of evidence and clinical equipoise among caregivers prompts the need for a head-to-head randomised controlled trial. The objective of this study is to compare the effect of primary DXM therapy versus primary BHC on functional outcome and cost-effectiveness in symptomatic patients with CSDH.Methods/DesignThis study is a prospective, multicentre, randomised controlled trial (RCT). Consecutive patients with a CSDH with a Markwalder Grading Scale (MGS) grade 1 to 3 will be randomised to treatment with DXM or BHC. The DXM treatment scheme will be 16 mg DXM per day (8 mg twice daily, days 1 to 4) which is then halved every 3 days until a dosage of 0.5 mg a day on day 19 and stopped on day 20. If the treatment response is insufficient (i.e. persistent or progressive symptomatology due to insufficient haematoma resolution), additional surgery can be performed. The primary outcomes are the functional outcome by means of the modified Rankin Scale (mRS) score at 3 months and cost-effectiveness at 12 months. Secondary outcomes are quality of life at 3 and 12 months using the Short Form Health Survey (SF-36) and Quality of Life after Brain Injury Overall Scale (QOLIBRI), haematoma thickness after 2 weeks on follow–up computed tomography (CT), haematoma recurrence during the first 12 months, complications and drug-related adverse events, failure of therapy within 12 months after randomisation and requiring intervention, mortality during the first 3 and 12 months, duration of hospital stay and overall healthcare and productivity costs. To test non-inferiority of DXM therapy compared to BHC, 210 patients in each treatment arm are required (assumed adjusted common odds ratio DXM compared to BHC 1.15, limit for inferiority < 0.9). The aim is to include a total of 420 patients in 3 years with an enrolment rate of 60%.DiscussionThe present study should demonstrate whether treatment with DXM is as effective as BHC on functional outcome, at lower costs.Trial registrationEUCTR 2015-001563-39. Date of registration: 29 March 2015.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2945-4) contains supplementary material, which is available to authorized users.

Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial

“…26 Current studies examining strategies to decrease risk of recurrence include the Swedish study of irrigation-fluid temperature in the evacuation of CSDH (SIC! ), 27 the Dutch dexamethasone therapy versus surgery for CSDH (DECSA trial), 28 the British dexamethasone for adult patients with a symptomatic CSDH trial, 29 and two Canadian studies looking at the role of tranexamic acid in the treatment of CSDHs (TRACS trial, NCT02568124 30 and TRACE trial, NCT03280212).…”

Risk of Recurrence of Chronic Subdural Hematomas After Surgery: A Multicenter Observational Cohort Study

“…Chronic Subdural Hematoma (CSDH) is a common condition affecting the elderly population (>65 years). Its general incidence, estimated between 1.72 and 20.6 per 100,000 persons per year (1), is currently rising due to the increasing age and widespread use of antiplatelet and anticoagulant drugs (2). The appropriate treatment could be conservative or, when symptoms of compression occur, surgical.…”

DIagnostic Subdural EEG electrodes And Subdural hEmatoma (DISEASE): a study protocol for a prospective nonrandomized controlled trial

“…Interest in subdural hematoma is currently rising, with lots of ongoing prospective studies being initiated [13][14][15][16]. While there are several new insights into the management and treatment of chronic subdural hematoma, there are less innovative developments regarding aSDH.…”