title: Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial.
abstract: Chronic subdural hematoma (CSDH) is a common disease that is more prevalent in older people. Surgical intervention is a safe treatment of choice. However, the recurrence rate is relatively high and the outcome is not always satisfactory among surgically treated patients. It is believed that aberrant angiogenesis and intracapsular inflammation contribute to the development of CSDH. Atorvastatin is reported to promote angiogenesis and suppress inflammation. We have recently shown that atorvastatin is effective to non-surgically reduce and eliminate CSDH with minimal side effects. Here, we report a clinical research trial protocol that is designed to evaluate the therapeutic effects of atorvastatin on CSDH.
  
  
  
  We have designed a multi-center, randomized, placebo-controlled, double blind clinical trial for evaluating the efficacy of oral atorvastatin in reducing CSDH. We have so far recruited 96 patients with CT-confirmed or MRI-confirmed CSDHs from 16 medical centers in China. These patients were originally recruited for the Oriental Neurosurgical Evidence-based Study Team (ONET) study. After informed consent is provided, patients are randomized to receive either atorvastatin (oral 20 mg/night for 8 weeks) or placebo (dextrin for 8 weeks); and followed for 16 weeks after the treatment. The primary outcome is the change in hematoma volume at the end of 8-week treatment. Secondary outcomes include: changes in 1) the hematoma volume at the 4(th), 12(th), and 24(th) weeks; 2) Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS); 3) Glasgow Outcome Score (GOS) and 4) Activities of Daily Life-the Barthel Index scale (ADL-BI). Safety will be assessed during the study by monitoring adverse events, laboratory tests, electrocardiography (ECG), measurements of vital signs (temperature, pulse, and blood pressure) and body weight.
  
  
  
  Results of this trial will provide critical information regarding whether atorvastatin is an effective and safe alternative to surgical treatment of CSDH.
  
  
  
  ClinicalTrials.gov Identifier--NCT02024373 The date of trial registration: 7 August 2013.
authors.affiliation: Department of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jiang116216@163.com.|Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jiang116216@163.com.|Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jiang116216@163.com.|Tianjin Neurological Institute, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jiang116216@163.com.|Oriental Neurosurgical Evidence-based Study Team (ONET) of People's Republic of China, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jiang116216@163.com.
authors.forename: Rongcai
authors.initials: R
authors.lastname: Jiang
authors.affiliation: Department of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. 54454241@qq.com.|Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, 154 Anshan Road, Tianjin, 300052, People's Republic of China. 54454241@qq.com.|Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, 154 Anshan Road, Tianjin, 300052, People's Republic of China. 54454241@qq.com.|Tianjin Neurological Institute, 154 Anshan Road, Tianjin, 300052, People's Republic of China. 54454241@qq.com.|Oriental Neurosurgical Evidence-based Study Team (ONET) of People's Republic of China, 154 Anshan Road, Tianjin, 300052, People's Republic of China. 54454241@qq.com.
authors.forename: Dong
authors.initials: D
authors.lastname: Wang
authors.affiliation: Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, New Territories East, Hong Kong. wpoon@cuhk.edu.hk.
authors.forename: Wai Sang
authors.initials: WS
authors.lastname: Poon
authors.affiliation: Department of Neurosurgery, Shanghai Changzheng Hospital, 415 Fengyang Street, Shanghai, 200003, People's Republic of China. lyc305@126.com.
authors.forename: Yi Cheng
authors.initials: YC
authors.lastname: Lu
authors.affiliation: Department of Neurosurgery, Qilu Hospital of Shandong University, 107 Wenhuaxi Street, Jinan, Shandong Province, 250012, People's Republic of China. Lixgang-ql@163.com.
authors.forename: Xin Gang
authors.initials: XG
authors.lastname: Li
authors.affiliation: Department of Neurosurgery, The First Affiliated hospital of Harbin Medical University, 23 Youzheng Street, Nangang district, Harbin, Heilongjiang Province, 150001, People's Republic of China. guangsz@hotmail.com.
authors.forename: Shi Guang
authors.initials: SG
authors.lastname: Zhao
authors.affiliation: Department of Neurosurgery, Peking Union Medical College Hospital, 41 Damucang Street, Xicheng district, Beijing, 100032, People's Republic of China. wangrz@126.com.
authors.forename: Ren Zhi
authors.initials: RZ
authors.lastname: Wang
authors.affiliation: Department of Neurosurgery, West China Hospital Sichuan University, 37 Guoxuegang Street, Wuhou district, Chengdu, Sichuan Province, 610041, People's Republic of China. youchao@vip.126.com.
authors.forename: Chao
authors.initials: C
authors.lastname: You
authors.affiliation: Department of Neurosurgery, Xiangya Hospital Central South University, 87 Xiangya Street, Changsha, Hunan Province, 410008, People's Republic of China. xry69@163.com.
authors.forename: Xian Rui
authors.initials: XR
authors.lastname: Yuan
authors.affiliation: Department of Neurosurgery, The Second Affiliated Hospital Zhejiang University School of Medicine, 88 Jiefang Road, Hangzhou, Zhejiang Province, 310009, People's Republic of China. zjm135@vip.sina.com.
authors.forename: Jian Min
authors.initials: JM
authors.lastname: Zhang
authors.affiliation: Department of Neurosurgery, Southwest Hospital, 30 Gaotanyanzheng Road, Shapingba district, Chongqing, Sichuan Province, 400038, People's Republic of China. fenghua8888@aliyun.com.
authors.forename: Hua
authors.initials: H
authors.lastname: Feng
authors.affiliation: Department of Neurosurgery, Xijing Hospital, 15 Changlexi Road, Xian, Shanxi Province, 710032, People's Republic of China. feizhou@fmmu.edu.cn.
authors.forename: Zhou
authors.initials: Z
authors.lastname: Fei
authors.affiliation: Department of Neurosurgery, The General Hospital of Chinese People's Liberation Army, 28 Fuxing Road, Beijing, 100853, People's Republic of China. xinguang_yu@263.net.
authors.forename: Xin Guang
authors.initials: XG
authors.lastname: Yu
authors.affiliation: Department of Neurosurgery, Beijing Tian Tan Hospital, Capital Medical University, 6 Tiantan Xili, Dongcheng district, Beijing, 100050, People's Republic of China. zhaoyuanli@126.com.
authors.forename: Yuan Li
authors.initials: YL
authors.lastname: Zhao
authors.affiliation: Department of Neurosurgery, Huashan Hospital Fudan University, 12 Wulumuqizhong Street, Shanghai, 200040, People's Republic of China. hujin_dana@126.com.
authors.forename: Jin
authors.initials: J
authors.lastname: Hu
authors.affiliation: Department of Neurosurgery, First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, Fujian Province, 350005, People's Republic of China. kdz99988@sina.com.
authors.forename: De Zhi
authors.initials: DZ
authors.lastname: Kang
authors.affiliation: Department of Neurosurgery, The Affiliated Hospital of Xuzhou Medical College, 99 Huaihaixi Road, Xuzhou, Huhehot, Jiangsu Province, 221006, People's Republic of China. yu.rutong@163.com.
authors.forename: Ru Tong
authors.initials: RT
authors.lastname: Yu
authors.affiliation: Department of Neurosurgery, Tangdu Hospital, The Second Affiliated hospital of the Fourth Military Medical University, 1 Xinsi Road, Xian, Shanxi Province, 710038, People's Republic of China. gguodong@fmmu.edu.cn.
authors.forename: Guo Dong
authors.initials: GD
authors.lastname: Gao
authors.affiliation: Department of Neurosurgery, Linyi People's Hospital, 27 Jiefang Road, Linyi, Shandong Province, 276003, People's Republic of China. Zxde366@163.com.
authors.forename: Xi De
authors.initials: XD
authors.lastname: Zhu
authors.affiliation: Department of Neurosurgery, General Hospital of Ningxia Medical University, 804 Shenglinan Road, Xingqing district, Yinchuan, Ningxia Province, 750004, People's Republic of China. suntao6699@163.com.
authors.forename: Tao
authors.initials: T
authors.lastname: Sun
authors.affiliation: Department of Neurosurgery, First Affiliated Hospital of Shanxi Medical University, 85 Jiefangnan Road, Taiyuan, Shanxi Province, 030001, People's Republic of China. hjh_560328@163.com.
authors.forename: Jie He
authors.initials: JH
authors.lastname: Hao
authors.affiliation: Department of Neurosurgery, The First Affiliated Hospital of Zhengzhou University, 1 Jianshedong Road, Zhengzhou, Henan Province, 450052, People's Republic of China. zzuliuxianzhi@126.com.
authors.forename: Xian Zhi
authors.initials: XZ
authors.lastname: Liu
authors.affiliation: Department of Neurosurgery, Inner Mongolia people's Hospital, 26 Zhaowuda Road, Saihan district, Huhehot, Inner Mongolia Province, 010017, People's Republic of China. Su_nin@sohu.com.
authors.forename: Ning
authors.initials: N
authors.lastname: Su
authors.affiliation: Department of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. yueshuyuan@163.com.|Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, 154 Anshan Road, Tianjin, 300052, People's Republic of China. yueshuyuan@163.com.|Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, 154 Anshan Road, Tianjin, 300052, People's Republic of China. yueshuyuan@163.com.|Tianjin Neurological Institute, 154 Anshan Road, Tianjin, 300052, People's Republic of China. yueshuyuan@163.com.|Oriental Neurosurgical Evidence-based Study Team (ONET) of People's Republic of China, 154 Anshan Road, Tianjin, 300052, People's Republic of China. yueshuyuan@163.com.
authors.forename: Shu Yuan
authors.initials: SY
authors.lastname: Yue
authors.affiliation: Department of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jianningzhang@hotmail.com.|Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jianningzhang@hotmail.com.|Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jianningzhang@hotmail.com.|Tianjin Neurological Institute, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jianningzhang@hotmail.com.|Oriental Neurosurgical Evidence-based Study Team (ONET) of People's Republic of China, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jianningzhang@hotmail.com.
authors.forename: Jian Ning
authors.initials: JN
authors.lastname: Zhang
mesh_terms: D000203:Activities of Daily Living; D000284:Administration, Oral; D000069059:Atorvastatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D002985:Clinical Protocols; D004311:Double-Blind Method; D015600:Glasgow Coma Scale; D020200:Hematoma, Subdural, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D011446:Prospective Studies; D012107:Research Design; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000069059:Atorvastatin