A randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic Chronic Subdural Haematoma (Dex-CSDH trial)

• PRINCIPAL RESEARCH QUESTION: In adult patients with a symptomatic chronic subdural haematoma (CSDH), what is the clinical and cost-effectiveness of a two-week course of dexamethasone compared to placebo? • DESIGN: The Dex-CSDH study is a randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic CSDH. Following successful completion of the internal pilot phase, we intend to roll out the substantive trial across the NHS. The project was designed as a collaborative effort involving members of the British Neurosurgical Trainee Research Collaborative (BNTRC; www.bntrc.org.uk), clinicians experienced in CSDH management and research, academics in the field of ageing research, members of the Cambridge Clinical Trials Unit, health economists and service user representatives. The project is supported by the Academic Committee of the Society of British Neurological Surgeons and the UK Neurosurgical Research Network. • SETTING: Participant enrolment, allocation and treatment will take place in participating neurosurgical units (NSU). • TARGET POPULATION: The study focuses on adult patients with a symptomatic CSDH confirmed on cranial imaging. CSDH is defined as a predominantly isodense or hypodense collection in the subdural space along the cerebral convexity on CT scanning. Symptoms that may be attributed to a CSDH include headache, gait disturbance, falls, confusion/cognitive disturbance, focal neurological deficit, speech disturbance, drowsiness/decreased consciousness and seizures. As per routine practice, the responsible clinical team will judge whether or not a symptom is attributable to the CSDH. - Inclusion criteria: 1. Adult patients aged 18 years or older. 2. Symptomatic CSDH confirmed on cranial imaging (e.g. CT/MRI - predominantly hypodense or isodense crescentic collection along the cerebral convexity on CT). 3. Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment. - Exclusion criteria: 1. Patients with conditions where steroids are clearly contra-indicated. 2. Patients who are on (or within 1 month of) regular oral or intravenous glucocorticoid steroids*. 3. Previous enrolment in this trial for a prior episode 4. Time interval from the time of admission to NSU to first dose of trial medication exceeds 72 hours. 5. CSDH in the presence of a cerebrospinal fluid (CSF) shunt. 6. Severe lactose intolerance or any known hypersensitivity to dexamethasone or any of the IMP (investigational medicinal product) excipients. 7. Patients with a previous history of psychotic disorders. 8. Unwillingness to take products containing gelatin. 9. Concurrent enrolment in any other trial of an investigational medicinal product. *Patients on topical or inhaled steroids are allowed to be recruited into the trial, as are patients who have had 1 intra-operative dose of dexamethasone for anti-emesis. • HEALTH TECHNOLOGIES BEING ASSESSED: A CSDH is a collection of liquefied blood between the dura mater (the outer lining of the brain) and the brain. In symptomatic patients with a CSDH exerting pressure on the brain the role of surgical evacuation of the liquefied blood is well established. The risk of symptomatic recurrence following evacuation is about 15-20% and this may require repeat surgical intervention if symptomatic. This has been shown to adversely affect long-term functional outcome. There is evidence from our previous trial of CSDH that the use of an intervention to reduce recurrence (subdural drain) also resulted in reduction in mortality and rate of poor outcome at 6 months. A considerable body of evidence suggests that administration of steroids can reduce the recurrence rate and the rate of surgical interventions. However, there is no high-quality evidence showing that steroids ca