PMID- 34895306
OWN - NLM
STAT- MEDLINE
DCOM- 20211214
LR  - 20211216
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 22
IP  - 1
DP  - 2021 Dec 11
TI  - Atorvastatin combined with dexamethasone in chronic subdural haematoma (ATOCH 
      II): study protocol for a randomized controlled trial.
PG  - 905
LID - 10.1186/s13063-021-05871-9 [doi]
LID - 905
AB  - BACKGROUND: Chronic 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. 
      METHODS: The 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 REGISTRATION: 
      ChiCTR, ChiCTR1900021659 . Registered on 3 March 2019, 
      http://www.chictr.org.cn/showproj.aspx?proj=36157 .
CI  - (c) 2021. The Author(s).
FAU - Jiang, Rong Cai
AU  - Jiang RC
AD  - 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.
FAU - Wang, Dong
AU  - Wang D
AD  - 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.
FAU - Zhao, Shi Guang
AU  - Zhao SG
AD  - Department 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.
FAU - Wang, Ren Zhi
AU  - Wang RZ
AD  - Department of Neurosurgery, Peking Union Medical College Hospital, No. 41 
      Damucang Street, Xicheng District, Beijing, 100032, People's Republic of China.
FAU - Kang, De Zhi
AU  - Kang Z
AD  - Department of Neurosurgery, The First Affiliated Hospital of Fujian Medical 
      University, No. 20 Chazhong Road, Fuzhou, Fujian Province, 350005, People's 
      Republic of China.
FAU - Zhu, Xin Gen
AU  - Zhu XG
AD  - Department of Neurosurgery, The Second Affiliated Hospital of Nanchang 
      University, No. 1 Minde Road, Nanchang, Jiangxi Province, 330006, People's 
      Republic of China.
FAU - Zhao, Zong Mao
AU  - Zhao ZM
AD  - Department of Neurosurgery, The Second Hospital of Hebei Medical University, No. 
      215 Heping West Road, Shijiazhuang, Hebei Province, 050000, People's Republic of 
      China.
FAU - Wei, Jun Ji
AU  - Wei JJ
AD  - Department of Neurosurgery, Peking Union Medical College Hospital, No. 41 
      Damucang Street, Xicheng District, Beijing, 100032, People's Republic of China.
FAU - Huang, Ying
AU  - Huang Y
AD  - Department of Neurosurgery, Tianjin Huanhu Hospital, No. 6 Jizhao Road, Tianjin, 
      300350, People's Republic of China.
FAU - Qu, Yan
AU  - Qu Y
AD  - Department 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.
FAU - Sun, Xiao Chuan
AU  - Sun XC
AD  - Department of Neurosurgery, The First Affiliated Hospital of Chongqing Medical 
      University, No. 1 Youyi Road, Chongqing, 630014, People's Republic of China.
FAU - Ji, Hong Ming
AU  - Ji HM
AD  - Department of Neurosurgery, Shanxi Provincial People's Hospital, No. 29 
      Shuangtasi Road, Taiyuan, Shanxi Province, 030012, People's Republic of China.
FAU - Jiang, Xiao Chun
AU  - Jiang XC
AD  - Department of Neurosurgery, Yejishan Hospital of Wannan Medical College, No. 2 
      West Zheshan Road, Wuhu, Anhui Province, 241001, People's Republic of China.
FAU - Liu, Jin Fang
AU  - Liu JF
AD  - Department of Neurosurgery, Xiangya Hospital Central South University, No. 87 
      Xiangya Road, Changsha, Hunan, 410008, People's Republic of China.
FAU - De Zhu, Xi
AU  - De Zhu X
AD  - Department of Neurosurgery, Linyi People's Hospital, No. 27 Jiefang Road, Linyi, 
      Shandong Province, 276003, People's Republic of China.
FAU - Wang, Jian Jun
AU  - Wang JJ
AD  - Department of Neurosurgery, Ordos Central Hospital, No. 23 Yijinhuoluo West 
      Street, Ordos, Inner Mongolia Province, 017000, People's Republic of China.
FAU - Tian, Ye
AU  - Tian Y
AD  - 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.
FAU - Gao, Chuang
AU  - Gao C
AD  - 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.
FAU - Wei, Hui Jie
AU  - Wei HJ
AD  - 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.
FAU - Zhang, Shu
AU  - Zhang S
AD  - 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.
FAU - Quan, Wei
AU  - Quan W
AD  - 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.
FAU - Yue, Shu Yuan
AU  - Yue SY
AD  - 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.
FAU - Lei, Ping
AU  - Lei P
AD  - 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.
FAU - Li, Xian
AU  - Li X
AD  - The George Institute China at Peking University Health Science Center, Beijing, 
      People's Republic of China.
AD  - The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, 
      Missenden Rd, Sydney, NSW, 2050, Australia.
FAU - Song, Li Li
AU  - Song LL
AD  - The George Institute China at Peking University Health Science Center, Beijing, 
      People's Republic of China.
AD  - The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, 
      Missenden Rd, Sydney, NSW, 2050, Australia.
FAU - Anderson, Craig S
AU  - Anderson CS
AD  - The George Institute China at Peking University Health Science Center, Beijing, 
      People's Republic of China. canderson@georgeinstitute.org.au.
AD  - The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, 
      Missenden Rd, Sydney, NSW, 2050, Australia. canderson@georgeinstitute.org.au.
AD  - Department of Neurology, Royal Prince Alfred Hospital, Sydney, Australia. 
      canderson@georgeinstitute.org.au.
FAU - Zhang, Jian Ning
AU  - Zhang JN
AD  - 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. jianningzhang@hotmail.com.
LA  - eng
GR  - 81671380/National Natural Science Foundation of China/
GR  - 81971173/National Natural Science Foundation of China/
GR  - 82171359/National Natural Science Foundation of China/
GR  - 82001323/National Natural Science Foundation of China/
GR  - 82071402/National Natural Science Foundation of China/
GR  - 19JCZDJC64600/Beijing Tianjin Hebei basic research cooperation project/
GR  - 15ZXLCSY00060/Tianjin science and technology program/
GR  - 19YFZCSY00650/Tianjin Science and Technology Committee/
GR  - 20JCYBJC00430/Tianjin Science and Technology Committee/
GR  - 20JCYBJC01380/Tianjin Science and Technology Committee/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20211211
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - A0JWA85V8F (Atorvastatin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Atorvastatin/adverse effects
MH  - Dexamethasone/adverse effects
MH  - Double-Blind Method
MH  - *Hematoma, Subdural, Chronic/diagnostic imaging/drug therapy
MH  - Humans
MH  - Multicenter Studies as Topic
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
PMC - PMC8666019
OTO - NOTNLM
OT  - Atorvastatin
OT  - Chronic subdural haematoma
OT  - Dexamethasone
OT  - Neurosurgery
OT  - Randomized controlled trial
COIS- The authors declare that they have no competing interests.
EDAT- 2021/12/14 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/12/11
CRDT- 2021/12/13 11:45
PHST- 2020/08/22 00:00 [received]
PHST- 2021/11/24 00:00 [accepted]
PHST- 2021/12/13 11:45 [entrez]
PHST- 2021/12/14 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/12/11 00:00 [pmc-release]
AID - 10.1186/s13063-021-05871-9 [pii]
AID - 5871 [pii]
AID - 10.1186/s13063-021-05871-9 [doi]
PST - epublish
SO  - Trials. 2021 Dec 11;22(1):905. doi: 10.1186/s13063-021-05871-9.