Abstract
BackgroundChronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions.MethodsDex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis.DiscussionThis multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition.Trial registrationISRCTN, ISRCTN80782810. Registered on 7 November 2014. EudraCT, 2014-004948-35. Registered on 20 March 2015.Dex-CSDH trial protocol version 3, 27 Apr 2017.This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.
Highlights
Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma
Several studies have supported the use of dexamethasone and shown some evidence of its efficacy in reducing recurrence or as a primary treatment for CSDH [3,4,5, 9]
Some clinicians are beginning to adopt dexamethasone as a treatment option in their routine practice. Assimilation of such new therapies into clinical care should be avoided until definitive evidence is available
Summary
Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions. It is radiologically defined as a predominantly hypodense or isodense collection in the subdural space along the cerebral convexity on computed tomography (CT) It is especially common in older patients and in the UK, 5000 people aged > 65 years are diagnosed with a CSDH each year. While the mechanism of action of steroids in CSDH is not entirely understood, recent research suggests that inflammation may be responsible for driving the continued growth of CSDH [6,7,8,9]; steroids may help overcome this
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