Evidence map›Paper›PMID 26581842›Full record

Trial reportTrials2015

Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial.

Rongcai Jiang, Dong Wang, Wai Sang Poon, Yi Cheng Lu, Xin Gang Li, Shi Guang Zhao, Ren Zhi Wang, Chao You, Xian Rui Yuan, Jian Min Zhang and 15 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02024373 (Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02024373 phase2completednot on this map

Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma

TypeinterventionalSponsorOriental Neurosurgery Evidence-Based-Study TeamRan2013 to 2016Enrolled200ConditionsChronic Subdural HematomaArmsAtorvastatin, placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 1 country.

Rongcai JiangDepartment of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jiang116216@163.com.
Dong WangDepartment of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. 54454241@qq.com.
Wai Sang PoonDivision of Neurosurgery, Department of Surgery, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, New Territories East, Hong Kong. wpoon@cuhk.edu.hk.
Yi Cheng LuDepartment of Neurosurgery, Shanghai Changzheng Hospital, 415 Fengyang Street, Shanghai, 200003, People's Republic of China. lyc305@126.com.
Xin Gang LiDepartment of Neurosurgery, Qilu Hospital of Shandong University, 107 Wenhuaxi Street, Jinan, Shandong Province, 250012, People's Republic of China. Lixgang-ql@163.com.
Shi Guang ZhaoDepartment 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.
Ren Zhi WangDepartment of Neurosurgery, Peking Union Medical College Hospital, 41 Damucang Street, Xicheng district, Beijing, 100032, People's Republic of China. wangrz@126.com.
Chao YouDepartment 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.
Xian Rui YuanDepartment of Neurosurgery, Xiangya Hospital Central South University, 87 Xiangya Street, Changsha, Hunan Province, 410008, People's Republic of China. xry69@163.com.
Jian Min ZhangDepartment 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.
Hua FengDepartment of Neurosurgery, Southwest Hospital, 30 Gaotanyanzheng Road, Shapingba district, Chongqing, Sichuan Province, 400038, People's Republic of China. fenghua8888@aliyun.com.
Zhou FeiDepartment of Neurosurgery, Xijing Hospital, 15 Changlexi Road, Xian, Shanxi Province, 710032, People's Republic of China. feizhou@fmmu.edu.cn.
Xin Guang YuDepartment 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.
Yuan Li ZhaoDepartment of Neurosurgery, Beijing Tian Tan Hospital, Capital Medical University, 6 Tiantan Xili, Dongcheng district, Beijing, 100050, People's Republic of China. zhaoyuanli@126.com.
Jin HuDepartment of Neurosurgery, Huashan Hospital Fudan University, 12 Wulumuqizhong Street, Shanghai, 200040, People's Republic of China. hujin_dana@126.com.
De Zhi KangDepartment of Neurosurgery, First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, Fujian Province, 350005, People's Republic of China. kdz99988@sina.com.
Ru Tong YuDepartment 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.
Guo Dong GaoDepartment 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.
Xi De ZhuDepartment of Neurosurgery, Linyi People's Hospital, 27 Jiefang Road, Linyi, Shandong Province, 276003, People's Republic of China. Zxde366@163.com.
Tao SunDepartment 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.
Jie He HaoDepartment 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.
Xian Zhi LiuDepartment of Neurosurgery, The First Affiliated Hospital of Zhengzhou University, 1 Jianshedong Road, Zhengzhou, Henan Province, 450052, People's Republic of China. zzuliuxianzhi@126.com.
Ning SuDepartment 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.
Shu Yuan YueDepartment of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. yueshuyuan@163.com.
Jian Ning ZhangDepartment of Neurosurgery, Tianjin Medical University General Hospital, 154 Anshan Road, Tianjin, 300052, People's Republic of China. jianningzhang@hotmail.com.
Tianjin Medical University General Hospital · CNTianjin People's Hospital · CNAir Force Medical University · CNCapital Medical University · CNChinese People's Liberation Army · CNChinese University of Hong Kong · CNFirst Affiliated Hospital of Fujian Medical University · CNFirst Affiliated Hospital of Harbin Medical University · CNFirst Affiliated Hospital of Zhengzhou University · CNHuashan Hospital · CNInner Mongolia People's Hospital · CNLinyi People's Hospital · CNNingxia Medical University · CNPeking Union Medical College Hospital · CNQilu Hospital of Shandong University · CNSecond Affiliated Hospital of Zhejiang University · CNShanghai Changzheng Hospital · CNShanxi Medical University · CNSichuan University · CNSouthwest Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic 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. METHODS/

designWe 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. DISCUSSION: Results of this trial will provide critical information regarding whether atorvastatin is an effective and safe alternative to surgical treatment of CSDH.

trial registrationClinicalTrials.gov Identifier--NCT02024373 The date of trial registration: 7 August 2013.

Indexed as

Activities of Daily LivingAdministration, OralAtorvastatinChinaClinical ProtocolsDouble-Blind MethodGlasgow Coma ScaleHematoma, Subdural, ChronicHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMagnetic Resonance ImagingProspective StudiesResearch DesignTime FactorsTomography, X-Ray ComputedTreatment OutcomeAtorvastatinHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID26581842
PMCPMC4652431
OpenAlexW2174259802

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.