ORCID
- Edlmann, Ellie: 0000-0002-7253-9115
Abstract
Abstract Background The 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 design Dex-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). Conclusions This paper and the accompanying additional material describe the statistical analysis plan for the trial. Trial registration ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.
DOI
10.1186/s13063-019-3866-6
Publication Date
2019-12-10
Publication Title
Trials
Volume
20
Issue
1
ISSN
1745-6215
Embargo Period
2021-09-29
Organisational Unit
Peninsula Medical School
Recommended Citation
Allison, A., Edlmann, E., Kolias, A., Davis-Wilkie, C., Mee, H., Thelin, E., Turner, C., Hutchinson, P., & Bond, S. (2019) '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', Trials, 20(1). Available at: https://doi.org/10.1186/s13063-019-3866-6
