To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
20 mg (every evening orally) for 8 weeks
20 mg (every evening orally) for 8 weeks
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)
Time frame: Check on 8 weeks during treatment (at the end)
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.
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.
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.
Hematoma Reduced Amount
Time frame: 4 weeks during treatment, in the follow-up in 12 and 24 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing tiantan hospital
Beijing, Beijing Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Chinese PLA General Hospital
Beijing, China
Peking union medical college hospital
Beijing, China
Cangzhou centerl hospital
Cangzhou, China
Xiangya hospital central southe university
Changsha, China
Southwest hospital
Chongqing, China
West china hospital
Chongqing, China
The first affiliated hospital of Fujian medical university
Fuzhou, China
Nanfang hospital
Guangzhou, China
...and 21 more locations