• Ellie Edlmann, Eric P Thelin, Karen Caldwell, Carole Turner, Peter Whitfield, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A Anderson, Oliver Richards, Monica Gherle, Emma Toman, Dipankar Nandi, Phillip Kane, Beatrice Pantaleo, Carol Davis-Wilkie, Silvia Tarantino, Garry Barton, Hani J Marcus, Aswin Chari, Antonio Belli, Simon Bond, Rafael Gafoor, Sarah Dawson, Lynne Whitehead, Paul Brennan, Ian Wilkinson, Angelos G Kolias, Hutchinson Peter J A PJA Department of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. , and Dex-CSDH trial collaborative and BNTRC collaborative..
• Department of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. ee291@cam.ac.uk.
• Sci Rep. 2019 Apr 10; 9 (1): 5885.

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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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

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