Trial Documents

Protocol (version 3.0)

Inclusion Criteria:
-  Adult patients (aged over 18)
- Symptomatic CSDH confirmed on cranial imaging
- Informed consent from patient, next of kin or IHP.

Exclusion Criteria:
- Patients with conditions where steroids are clearly contra-indicated
- Patients who are on (or within 1 month of) regular oral or intravenous corticosteroids.
- Previous enrolment in this trial for a prior episode
- Time interval from admission to neurosurgical unit to first dose of trial medication exceeds 72hrs.
- CSDH in presence of a cerebrospinal fluid (CSF) shunt
- Severe lactose intolerance or any known hypersensitivity to dexamethasone or any investigational medicinal product (IMP) excipients
- Patients with a previous history of psychotic disorders
- Unwillingness to take products containing gelatin
- Concurrent enrolment in any other trial of an IMP