Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase.

摘要: The Dex-CSDH trial is a randomised, double-blind, placebo-controlled of dexamethasone for patients with symptomatic chronic subdural haematoma. commenced an internal pilot, whose primary objective was to assess the feasibility multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed recruit 100 from United Kingdom Neurosurgical Units within 12 months. Trial participants randomised 2-week course or placebo in addition receiving standard care (which could include surgery). measure modified Rankin Scale at 6 This pilot recruited ahead target; nine months commencement. 47% screened consented collected 98% patients. No concerns raised by independent monitoring ethics committee only five withdrawn drug treatment. Pilot can inform on design resource provision substantive trials. successful determining recruitment feasibility. Excellent follow-up rates achieved exploratory measures added increase scientific value trial.