Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma
- Registration Number
- NCT02024373
- Lead Sponsor
- Oriental Neurosurgery Evidence-Based-Study Team
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo placebo:20 mg (every evening orally) for 8 weeks Atorvastatin Atorvastatin atorvastatin：20 mg (every evening orally) for 8 weeks
- Primary Outcome Measures
Name Time Method Hematoma Reduced Amount. Check on 8 weeks during treatment (at the end) 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
Name Time Method Hematoma Reduced Amount 4 weeks during treatment, in the follow-up in 12 and 24 weeks. The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. Changes of routine blood test and coagulation results 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. Changes of neurological symptoms and signs 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Trial Locations
- Locations (31)
Chinese PLA General Hospital
🇨🇳Beijing, China
West china hospital
🇨🇳Chongqing, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Beijing tiantan hospital
🇨🇳Beijing, Beijing, China
Cangzhou centerl hospital
🇨🇳Cangzhou, China
Xiangya hospital central southe university
🇨🇳Changsha, China
Peking union medical college hospital
🇨🇳Beijing, China
Southwest hospital
🇨🇳Chongqing, China
Hainan general hospital
🇨🇳Haikou, China
First Affiliated Hospital of Harbin Medical University
🇨🇳Haerbing, China
The first affiliated hospital of Fujian medical university
🇨🇳Fuzhou, China
Nanfang hospital
🇨🇳Guangzhou, China
117 Hospital of People's Liberation Army
🇨🇳Hangzhou, China
Anhui provincial hospital
🇨🇳Hefei, China
The second Affiliated hospital of zhejiang university school of medicine
🇨🇳Hangzhou, China
Inner mongolia people's hospital
🇨🇳Hohehot, China
Qilu hospital of shandong university
🇨🇳Jinan, China
Ordos Central Hospital
🇨🇳Ordos, China
The second hospital of Hebei medical university
🇨🇳Shijiazhuang, China
Linyi People's Hospital
🇨🇳Linyi, China
Changzheng Hospital
🇨🇳Shanghai, China
Huashan hospital
🇨🇳Shanghai, China
Tongji hospital
🇨🇳Wuhan, China
Jiangsu province hospital
🇨🇳Nanjing, China
The first hospital of Shanxi medical university
🇨🇳Taiyuan, China
Prince of Wales Hospital
🇨🇳Xianggang, China
Tangdu hospital
🇨🇳Xian, China
Xijing Hospital
🇨🇳Xian, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, China