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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.
- Source :
- Trials; 12/10/2019, Vol. 20 Issue 1, p1-5, 5p
- Publication Year :
- 2019
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- DEXAMETHASONE
STATISTICS
CLINICAL trials
HEMATOMA
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 20
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 140292623
- Full Text :
- https://doi.org/10.1186/s13063-019-3866-6