• Trials · Dec 2019

    Letter

    Statistical analysis plan for the Dex-CSDH trial: a randomised, double-blind, placebo-controlled trial of a 2-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma.

    • Annabel Allison, Ellie Edlmann, Angelos G Kolias, Carol Davis-Wilkie, Harry Mee, Eric P Thelin, Carole Turner, Peter J Hutchinson, and Simon Bond.
    • Cambridge Clinical Trials Unit, Coton House Level 6, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK. ara41@medschl.cam.ac.uk.
    • Trials. 2019 Dec 10; 20 (1): 698.

    BackgroundThe incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched in the UK in 2015 aiming to determine whether, compared to placebo, dexamethasone can improve the 6-month functional outcome of patients with symptomatic CSDH by reducing the rate of surgical intervention and recurrence rate.Methods And DesignDex-CSDH is a multi-centre, pragmatic, parallel group, double-blind, randomised trial assessing the clinical utility of a 2-week course of dexamethasone following a CSDH. Seven hundred fifty patients were randomised to either dexamethasone or placebo. The primary outcome is the modified Rankin Scale at 6 months which is dichotomised to favourable (a score of 0-3) versus unfavourable (a score of 4-6).ConclusionsThis paper and the accompanying additional material describe the statistical analysis plan for the trial.Trial RegistrationISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.

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