Clinical trial NCT02024373: Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma
Official title: Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Subdural Hematoma
Keywords: chronic subdural hematoma
Atorvastatin
oral administration therapy
Lead sponsor: Oriental Neurosurgery Evidence-Based-Study Team
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).

Detailed description: Study design:

Multi-center, randomized, double-blind, placebo parallel controlled

Subjects:

Patients with chronic subdural hematoma (CSDH)

Sample size:

200, including an Atorvastatin-treated group of 100 patients and a control group of 100 subjects.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 and \<90 years old, male or female;
2. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
3. Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)\<Grade 3;
4. Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;
5. Patients have never undergo surgery on the hematoma
6. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion Criteria:

1. Allergic to the statin or its ingredients
2. Cerebral herniation might occur at any time;
3. Hematoma leads to herniation and warrants surgical operation.
4. Hematoma caused by tumors, blood and other known comorbidities;
5. Abnormal liver function
6. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study
7. Patients have been on oral Statin treatment for a long time.
8. Patients have been on oral Steroids treatment for a long time.
9. Participate in clinical trials in the past four weeks;
10. Pregnant or breastfeeding
11. Failure of completing the trial by poor compliance;
12. For any reason, the researchers believe that the case is not suitable for inclusion.

Primary outcomes:
measure: Hematoma Reduced Amount.
timeFrame: Check on 8 weeks during treatment (at the end)
Secondary outcomes:
measure: The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects
timeFrame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
measure: Changes of neurological symptoms and signs
timeFrame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
measure: Changes of routine blood test and coagulation results
timeFrame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
measure: Hematoma Reduced Amount
timeFrame: 4 weeks during treatment, in the follow-up in 12 and 24 weeks.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing tiantan hospital
state: Beijing
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Peking union medical college hospital
city: Cangzhou
country: China
facility: Cangzhou centerl hospital
city: Changsha
country: China
facility: Xiangya hospital central southe university
city: Chongqing
country: China
facility: Southwest hospital
city: Chongqing
country: China
facility: West china hospital
city: Fuzhou
country: China
facility: The first affiliated hospital of Fujian medical university
city: Guangzhou
country: China
facility: Nanfang hospital
city: Haerbing
country: China
facility: First Affiliated Hospital of Harbin Medical University
city: Haikou
country: China
facility: Hainan general hospital
city: Hangzhou
country: China
facility: 117 Hospital of People's Liberation Army
city: Hangzhou
country: China
facility: The second Affiliated hospital of zhejiang university school of medicine
city: Hefei
country: China
facility: Anhui provincial hospital
city: Hohehot
country: China
facility: Inner mongolia people's hospital
city: Jinan
country: China
facility: Qilu hospital of shandong university
city: Linyi
country: China
facility: Linyi People's Hospital
city: Nanjing
country: China
facility: Jiangsu province hospital
city: Ordos
country: China
facility: Ordos Central Hospital
city: Shanghai
country: China
facility: Changzheng Hospital
city: Shanghai
country: China
facility: Huashan hospital
city: Shijiazhuang
country: China
facility: The second hospital of Hebei medical university
city: Taiyuan
country: China
facility: The first hospital of Shanxi medical university
city: Wuhan
country: China
facility: Tongji hospital
city: Xianggang
country: China
facility: Prince of Wales Hospital
city: Xian
country: China
facility: Tangdu hospital
city: Xian
country: China
facility: Xijing Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Ning jian zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang D, Tian Y, Wei H, Gao C, Fan Y, Yang G, Quan W, Huang J, Yue S, Zhang J, Jiang R. Risk Factor Analysis of the Conservative Treatment in Chronic Subdural Hematomas: A Substudy of the ATOCH Trial. Adv Ther. 2022 Apr;39(4):1630-1641. doi: 10.1007/s12325-022-02057-w. Epub 2022 Feb 8.
citation: Jiang R, Zhao S, Wang R, Feng H, Zhang J, Li X, Mao Y, Yuan X, Fei Z, Zhao Y, Yu X, Poon WS, Zhu X, Liu N, Kang D, Sun T, Jiao B, Liu X, Yu R, Zhang J, Gao G, Hao J, Su N, Yin G, Zhu X, Lu Y, Wei J, Hu J, Hu R, Li J, Wang D, Wei H, Tian Y, Lei P, Dong JF, Zhang J. Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients: A Randomized ClinicalTrial. JAMA Neurol. 2018 Nov 1;75(11):1338-1346. doi: 10.1001/jamaneurol.2018.2030.
citation: Jiang R, Wang D, Poon WS, Lu YC, Li XG, Zhao SG, Wang RZ, You C, Yuan XR, Zhang JM, Feng H, Fei Z, Yu XG, Zhao YL, Hu J, Kang DZ, Yu RT, Gao GD, Zhu XD, Sun T, Hao JH, Liu XZ, Su N, Yue SY, Zhang JN. Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial. Trials. 2015 Nov 18;16:528. doi: 10.1186/s13063-015-1045-y.