A corrected protocol for a trial of dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) has recently been published in a BioMed Central Journal.
Dex-CSDH, led by Peter Hutchinson (Medicine) and sponsored by CUHFT/ University of Cambridge, is a pragmatic, multi-centre, double-blind, phase III randomised, placebo-controlled trial (n=750) assessing the clinical utility of a tapering 2-week course of dexamethasone following Chronic Subdural Haematoma. Stage 1 will take place initially in a limited number of centres in the UK, to ensure feasibility. If successful, stage 2 will follow and will encompass, where possible, all remaining Neurosurgical centres in the UK and the Republic of Ireland.
Stage 1 aims to recruit 100 patients within 12 months. If the progression rules are met, Stage 2 will recruit 650 patients within 2 years. The recruitment rate has been estimated at 2 patients per site per month. On the basis of hospital episode statistics (HES) and data from the ongoing national CSDH audit, approximately 60-80 patients with a CSDH are admitted in a medium-sized neurosurgical unit each year. Hence, the estimated recruitment rate is feasible. Patients will be monitored whilst in the acute Neurosurgical unit and followed up for a period of 6 months post recruitment.
For more information visit: BioMed Central
Published January 6, 2020
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