Evidence map›Paper›PMID 34895306›Full record

ArticleTrials2021

Atorvastatin combined with dexamethasone in chronic subdural haematoma (ATOCH II): study protocol for a randomized controlled trial.

Rong Cai Jiang, Dong Wang, Shi Guang Zhao, Ren Zhi Wang, De Zhi Kang, Xin Gen Zhu, Zong Mao Zhao, Jun Ji Wei, Ying Huang, Yan Qu and 17 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 30% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 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

27 authors at 16 institutions in 2 countries.

Rong Cai Jiang *Department of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Dong Wang *Department of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Shi Guang ZhaoDepartment of Neurosurgery, The First Affiliated Hospital of Harbin Medical University, No. 23 Youzheng Street, Nangang District, Harbin, Heilongjiang Province, 150001, People's Republic of China.
Ren Zhi WangDepartment of Neurosurgery, Peking Union Medical College Hospital, No. 41 Damucang Street, Xicheng District, Beijing, 100032, People's Republic of China.
De Zhi KangDepartment of Neurosurgery, The First Affiliated Hospital of Fujian Medical University, No. 20 Chazhong Road, Fuzhou, Fujian Province, 350005, People's Republic of China.
Xin Gen ZhuDepartment of Neurosurgery, The Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Nanchang, Jiangxi Province, 330006, People's Republic of China.
Zong Mao ZhaoDepartment of Neurosurgery, The Second Hospital of Hebei Medical University, No. 215 Heping West Road, Shijiazhuang, Hebei Province, 050000, People's Republic of China.
Jun Ji WeiDepartment of Neurosurgery, Peking Union Medical College Hospital, No. 41 Damucang Street, Xicheng District, Beijing, 100032, People's Republic of China.
Ying HuangDepartment of Neurosurgery, Tianjin Huanhu Hospital, No. 6 Jizhao Road, Tianjin, 300350, People's Republic of China.
Yan QuDepartment of Neurosurgery, Tangdu Hospital, The Second Affiliated Hospital of Air Force Medical University, No. 1 Xinsi Road, Xian, Shanxi Province, 710038, People's Republic of China.
Xiao Chuan SunDepartment of Neurosurgery, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Chongqing, 630014, People's Republic of China.
Hong Ming JiDepartment of Neurosurgery, Shanxi Provincial People's Hospital, No. 29 Shuangtasi Road, Taiyuan, Shanxi Province, 030012, People's Republic of China.
Xiao Chun JiangDepartment of Neurosurgery, Yejishan Hospital of Wannan Medical College, No. 2 West Zheshan Road, Wuhu, Anhui Province, 241001, People's Republic of China.
Jin Fang LiuDepartment of Neurosurgery, Xiangya Hospital Central South University, No. 87 Xiangya Road, Changsha, Hunan, 410008, People's Republic of China.
Xi De ZhuDepartment of Neurosurgery, Linyi People's Hospital, No. 27 Jiefang Road, Linyi, Shandong Province, 276003, People's Republic of China.
Jian Jun WangDepartment of Neurosurgery, Ordos Central Hospital, No. 23 Yijinhuoluo West Street, Ordos, Inner Mongolia Province, 017000, People's Republic of China.
Ye TianDepartment of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Chuang GaoDepartment of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Hui Jie WeiDepartment of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Shu ZhangDepartment of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Wei QuanDepartment of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Shu Yuan YueDepartment of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Ping LeiDepartment of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Xian LiThe George Institute China at Peking University Health Science Center, Beijing, People's Republic of China.
Li Li SongThe George Institute China at Peking University Health Science Center, Beijing, People's Republic of China.
Craig S AndersonThe George Institute China at Peking University Health Science Center, Beijing, People's Republic of China. canderson@georgeinstitute.org.au.
Jian Ning ZhangDepartment of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China. jianningzhang@hotmail.com.
Tianjin Medical University General Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNThe George Institute for Global Health · AUAir Force Medical University · CNCentral South University · CNChongqing Medical University · CNFujian Medical University · CNHarbin Medical University · CNLinyi People's Hospital · CNNanchang University · CNPeking University · CNSecond Hospital of Hebei Medical University · CNShanxi Medical University · CNTianjin Huanhu Hospital · CNWannan Medical College · CNXuzhou Central Hospital · CN

Funding

Beijing Tianjin Hebei basic research cooperation project 19JCZDJC64600National Natural Science Foundation of China 81671380National Natural Science Foundation of China 81971173National Natural Science Foundation of China 82001323National Natural Science Foundation of China 82071402National Natural Science Foundation of China 82171359Tianjin Science and Technology Committee 19YFZCSY00650Tianjin Science and Technology Committee 20JCYBJC00430Tianjin Science and Technology Committee 20JCYBJC01380Tianjin science and technology program 15ZXLCSY00060
6 · The paper itself

Abstract

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. DISCUSSION: This 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 .

Indexed as

Hematoma, Subdural, ChronicAdultAgedAtorvastatinDexamethasoneDouble-Blind MethodHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAtorvastatinDexamethasoneAtorvastatinChronic subdural haematomaDexamethasoneNeurosurgeryRandomized controlled trial

Identifiers

PMID34895306
PMCPMC8666019
OpenAlexW4200415281

What Socratic holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.