دورية أكاديمية
Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial.
| العنوان: | Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial. |
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| المؤلفون: | Kolias, Angelos G, Edlmann, Ellie, Thelin, Eric P, Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z, Gatt, Daniel, Thomson, Simon, Anderson, Ian A, Richards, Oliver, Whitfield, Peter, Gherle, Monica, Caldwell, Karen, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J, Chari, Aswin, Brennan, Paul, Belli, Antonio, Bond, Simon, Turner, Carole, Whitehead, Lynne, Wilkinson, Ian, Hutchinson, Peter J, British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators |
| بيانات النشر: | Springer Science and Business Media LLC //dx.doi.org/10.1186/s13063-018-3050-4 Trials |
| سنة النشر: | 2018 |
| المجموعة: | Apollo - University of Cambridge Repository |
| مصطلحات موضوعية: | Chronic subdural haematoma, Dexamethasone, Neurology, Neurosurgery, Randomised control trial, Cost-Benefit Analysis, Double-Blind Method, Drug Administration Schedule, Drug Costs, Glucocorticoids, Hematoma, Subdural, Chronic, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Time Factors, Treatment Outcome, United Kingdom |
| الوصف: | BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions. METHODS: Dex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis. DISCUSSION: This multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | Electronic; application/pdf |
| اللغة: | English |
| العلاقة: | https://www.repository.cam.ac.uk/handle/1810/288897Test |
| DOI: | 10.17863/CAM.36160 |
| الإتاحة: | https://doi.org/10.17863/CAM.36160Test https://www.repository.cam.ac.uk/handle/1810/288897Test |
| حقوق: | Attribution 4.0 International ; https://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: | edsbas.A41476B0 |
| قاعدة البيانات: | BASE |
| DOI: | 10.17863/CAM.36160 |
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