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): 698, 2019 Dec 10.
Article
em En
| MEDLINE
| ID: mdl-31822298
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 ANDDESIGN:
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Dexametasona
/
Hematoma Subdural Crônico
/
Glucocorticoides
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
Trials
Assunto da revista:
MEDICINA
/
TERAPEUTICA
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Reino Unido