Back to resultsEffect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma
Primary Purpose
Chronic Subdural Hematoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring chronic subdural hematoma, Atorvastatin, oral administration therapy
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and <90 years old, male or female;
- CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
- Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3;
- 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;
- Patients have never undergo surgery on the hematoma
- Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.
Exclusion Criteria:
- Allergic to the statin or its ingredients
- Cerebral herniation might occur at any time;
- Hematoma leads to herniation and warrants surgical operation.
- Hematoma caused by tumors, blood and other known comorbidities;
- Abnormal liver function
- Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study
- Patients have been on oral Statin treatment for a long time.
- Patients have been on oral Steroids treatment for a long time.
- Participate in clinical trials in the past four weeks;
- Pregnant or breastfeeding
- Failure of completing the trial by poor compliance;
- For any reason, the researchers believe that the case is not suitable for inclusion.
Sites / Locations
- Beijing tiantan hospital
- Tianjin Medical University General Hospital
- Chinese PLA General Hospital
- Peking union medical college hospital
- Cangzhou centerl hospital
- Xiangya hospital central southe university
- Southwest hospital
- West china hospital
- The first affiliated hospital of Fujian medical university
- Nanfang hospital
- First Affiliated Hospital of Harbin Medical University
- Hainan general hospital
- 117 Hospital of People's Liberation Army
- The second Affiliated hospital of zhejiang university school of medicine
- Anhui provincial hospital
- Inner mongolia people's hospital
- Qilu hospital of shandong university
- Linyi People's Hospital
- Jiangsu province hospital
- Ordos Central Hospital
- Changzheng Hospital
- Huashan hospital
- The second hospital of Hebei medical university
- The first hospital of Shanxi medical university
- Tongji hospital
- Prince of Wales Hospital
- Tangdu hospital
- Xijing Hospital
- The Affiliated Hospital of Xuzhou Medical College
- General Hospital of Ningxia Medical University
- The First Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atorvastatin
placebo
Arm Description
atorvastatin：20 mg (every evening orally) for 8 weeks
placebo:20 mg (every evening orally) for 8 weeks
Outcomes
Primary Outcome Measures
Hematoma Reduced Amount.
The primary efficacy endpoint: hematoma reduced amount. Outcome Measures: all patients underwent head CT (plain scan) before treatment, and check on 8 weeks during treatment (at the end)
Secondary Outcome Measures
The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects
Changes of neurological symptoms and signs
Changes of routine blood test and coagulation results
Hematoma Reduced Amount
Full Information
NCT ID
NCT02024373
First Posted
August 7, 2013
Last Updated
October 24, 2016
Sponsor
Oriental Neurosurgery Evidence-Based-Study Team
1. Study Identification
Unique Protocol Identification Number
NCT02024373
Brief Title
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
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oriental Neurosurgery Evidence-Based-Study Team
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
chronic subdural hematoma, Atorvastatin, oral administration therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
atorvastatin：20 mg (every evening orally) for 8 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo:20 mg (every evening orally) for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
20 mg (every evening orally) for 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
20 mg (every evening orally) for 8 weeks
Primary Outcome Measure Information:
Title
Hematoma Reduced Amount.
Description
The primary efficacy endpoint: hematoma reduced amount. Outcome Measures: all patients underwent head CT (plain scan) before treatment, and check on 8 weeks during treatment (at the end)
Time Frame
Check on 8 weeks during treatment (at the end)
Secondary Outcome Measure Information:
Title
The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects
Time Frame
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Title
Changes of neurological symptoms and signs
Time Frame
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Title
Changes of routine blood test and coagulation results
Time Frame
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Title
Hematoma Reduced Amount
Time Frame
4 weeks during treatment, in the follow-up in 12 and 24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 and <90 years old, male or female;
CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3;
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;
Patients have never undergo surgery on the hematoma
Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.
Exclusion Criteria:
Allergic to the statin or its ingredients
Cerebral herniation might occur at any time;
Hematoma leads to herniation and warrants surgical operation.
Hematoma caused by tumors, blood and other known comorbidities;
Abnormal liver function
Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study
Patients have been on oral Statin treatment for a long time.
Patients have been on oral Steroids treatment for a long time.
Participate in clinical trials in the past four weeks;
Pregnant or breastfeeding
Failure of completing the trial by poor compliance;
For any reason, the researchers believe that the case is not suitable for inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning jian zhang, MD, PhD
Organizational Affiliation
Tianjin Medical University General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing tiantan hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Facility Name
Peking union medical college hospital
City
Beijing
Country
China
Facility Name
Cangzhou centerl hospital
City
Cangzhou
Country
China
Facility Name
Xiangya hospital central southe university
City
Changsha
Country
China
Facility Name
Southwest hospital
City
Chongqing
Country
China
Facility Name
West china hospital
City
Chongqing
Country
China
Facility Name
The first affiliated hospital of Fujian medical university
City
Fuzhou
Country
China
Facility Name
Nanfang hospital
City
Guangzhou
Country
China
Facility Name
First Affiliated Hospital of Harbin Medical University
City
Haerbing
Country
China
Facility Name
Hainan general hospital
City
Haikou
Country
China
Facility Name
117 Hospital of People's Liberation Army
City
Hangzhou
Country
China
Facility Name
The second Affiliated hospital of zhejiang university school of medicine
City
Hangzhou
Country
China
Facility Name
Anhui provincial hospital
City
Hefei
Country
China
Facility Name
Inner mongolia people's hospital
City
Hohehot
Country
China
Facility Name
Qilu hospital of shandong university
City
Jinan
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
Country
China
Facility Name
Jiangsu province hospital
City
Nanjing
Country
China
Facility Name
Ordos Central Hospital
City
Ordos
Country
China
Facility Name
Changzheng Hospital
City
Shanghai
Country
China
Facility Name
Huashan hospital
City
Shanghai
Country
China
Facility Name
The second hospital of Hebei medical university
City
Shijiazhuang
Country
China
Facility Name
The first hospital of Shanxi medical university
City
Taiyuan
Country
China
Facility Name
Tongji hospital
City
Wuhan
Country
China
Facility Name
Prince of Wales Hospital
City
Xianggang
Country
China
Facility Name
Tangdu hospital
City
Xian
Country
China
Facility Name
Xijing Hospital
City
Xian
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35133631
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.
Results Reference
derived
PubMed Identifier
30073290
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.
Results Reference
derived
PubMed Identifier
26581842
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.
Results Reference
derived
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Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma
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