Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial

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.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3050-4) contains supplementary material, which is available to authorized users.

Drain type after burr-hole drainage of chronic subdural hematoma in geriatric patients: a subanalysis of the cSDH-Drain randomized controlled trial

“…9 However, ongoing RCTs are investigating the value of corticosteroids as stand-alone and adjacent treatment to surgery for CSDH. 13,14 A recent placebo-controlled RCT showed that atorvastatin significantly lowers hematoma volume and neurological symptoms as a stand-alone treatment of cSDH. 15 Hence, atorvastatin could be considered a pharmacological treatment, especially for geriatric patients who are often highrisk surgical candidates.…”

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).…”

Effects of dexamethasone in traumatic brain injury patients with pericontusional vasogenic edema

“…[ 12 ] This dose and duration are similar to other studies currently ongoing in TBI patients. [ 9 , 10 ]…”

“…Nevertheless based on the experience with patients with brain tumors, dexamethasone is commonly administered to patients undergoing a variety of neurosurgical procedures, [ 8 ] and is currently under investigation in specific subgroups of TBI patients like patients with chronic subdural hematomas. [ 9 , 10 ] Among the groups of patients that occasionally receive dexamethasone are patients with brain contusions and pericontusional edema where steroids are believed to improve the vasogenic component.…”