Journal Article

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

Dirven, Clemens M. F., van Kooten, Fop, van der Naalt, Joukje, de Laat, Karlijn, Holl, Dana C., Jacobs, Bram, Walchenbach, Robert, Groen, Rob J. M., Volovici, Victor, den Hertog, Heleen M., Kho, Kuan H., Kruyt, Nyika, Lingsma, Hester F., van der Gaag, Niels A., Peul, Wilco C., Jellema, Korné, Miah, Ishita P., Koot, Radboud W., Dammers, Ruben

2018

Overview

Background Chronic 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/Design This 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%. Discussion The present study should demonstrate whether treatment with DXM is as effective as BHC on functional outcome, at lower costs. Trial registration EUCTR 2015-001563-39 . Date of registration: 29 March 2015.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analysis / Anticoagulants / Anticoagulants - therapeutic use / BHC / Biomedicine / Burr-hole craniostomy / Care and treatment / Chronic subdural haematoma / Clinical trials / Comparative analysis / Cost analysis / Cost-Benefit Analysis / Craniotomy - adverse effects / Craniotomy - economics / CSDH / Data Analysis / Dexamethasone / Dexamethasone - therapeutic use / Dosage and administration / DXM / Fibrinolytic Agents - therapeutic use / Health Care Costs / Health Sciences / Hematoma, Subdural, Chronic - therapy / Hospitals / Humans / Intervention / Medicine / Medicine & Public Health / Mortality / Multicenter Studies as Topic / Older people / Outcome Assessment, Health Care / Outpatient care facilities / Patients / Productivity / Prospective Studies / Quality of Life / Randomized Controlled Trials as Topic / Statistics for Life Sciences / Steroids / Study Protocol / Subdural hematoma / Surgery / Tomography