Atorvastatin combined with dexamethasone in chronic subdural haematoma (ATOCH II): study protocol for a randomized controlled trial
| Autor: | Hong Ming Ji, Yan Qu, Zong Mao Zhao, Dong Wang, Xian Li, Shu Zhang, Shi Guang Zhao, Ye Tian, Jun Ji Wei, De Zhi Kang, Craig S Anderson, Li Li Song, Xi De Zhu, Ping Lei, Jianning Zhang, Ren Zhi Wang, Wei Quan, Chuang Gao, Jin Fang Liu, Xin Gen Zhu, Ying Huang, Shu Yuan Yue, Rong Cai Jiang, Xiao Chuan Sun, Xiao Chun Jiang, Hui Jie Wei, Jian Jun Wang |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
Medicine (General) Atorvastatin Neurosurgery Medicine (miscellaneous) Dexamethasone Chronic subdural haematoma law.invention Study Protocol R5-920 Randomized controlled trial Double-Blind Method law medicine Humans Multicenter Studies as Topic Pharmacology (medical) cardiovascular diseases Aged Randomized Controlled Trials as Topic business.industry Treatment Outcome Anesthesia Hematoma Subdural Chronic business medicine.drug |
| Zdroj: | Trials, Vol 22, Iss 1, Pp 1-12 (2021) Trials |
| ISSN: | 1745-6215 |
| Popis: | BackgroundChronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve outcomes, presumably by reducing local inflammation and promoting vascular repair. We wish to extend this evidence in a study that aims to determine the efficacy and safety of atorvastatin combined with low-dose dexamethasone in patients with CSDH.MethodsThe second ATorvastatin On Chronic subdural Hematoma (ATOCH-II) study is a multi-centre, randomized, placebo-controlled, double-blind trial which aims to enrol 240 adult patients with a conservative therapeutic indication for CSDH, randomly allocated to standard treatment with atorvastatin 20 mg combined with low-dose dexamethasone (or matching placebos) daily for 28 days, and with 152 days of follow-up. The primary outcome is a composite good outcome defined by any reduction from baseline in haematoma volume and survival free of surgery at 28 days. Secondary outcomes include functional outcome on the modified Rankin scale (mRS) and modified Barthel Index at 28 days, surgical transition and reduction in haematoma volumes at 14, 28 and 90 days.DiscussionThis multi-centre clinical trial aims to provide high-quality evidence on the efficacy and safety of the combined treatment of atorvastatin and low-dose dexamethasone to reduce inflammation and enhance angiogenesis in CSDH.Trial registrationChiCTR,ChiCTR1900021659. Registered on 3 March 2019,http://www.chictr.org.cn/showproj.aspx?proj=36157. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink