We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
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.
- Authors
Allison, Annabel; Edlmann, Ellie; Kolias, Angelos G.; Davis-Wilkie, Carol; Mee, Harry; Thelin, Eric P.; Turner, Carole; Hutchinson, Peter J.; Bond, Simon
- Abstract
<bold>Background: </bold>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.<bold>Methods and Design: </bold>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).<bold>Conclusions: </bold>This paper and the accompanying additional material describe the statistical analysis plan for the trial.<bold>Trial Registration: </bold>ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.
- Subjects
UNITED Kingdom; DEXAMETHASONE; STATISTICS; CLINICAL trials; HEMATOMA
- Publication
Trials, 2019, Vol 20, Issue 1, p1
- ISSN
1745-6215
- Publication type
letter
- DOI
10.1186/s13063-019-3866-6