To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
Study design: Two-arm,Evaluator-blinded study Subjects: CSDH patients with Coagulation Disorders(Conservative treatment is adopted) Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
20 mg (every evening orally) for 5 weeks
Atorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Changes of hematoma volume
After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.
Time frame: 2,5,12 weeks during treatment
Outcome score (GOSE) in subjects
Time frame: 2,5,12 weeks during treatment
Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis
Time frame: 2,5,12 weeks during treatment
Changes of neurological symptoms and signs
Time frame: 2,5,12 weeks during treatment
Recurrence and prognosis of patient failure in those conservative treatment
Time frame: 2,5,12 weeks during treatment
Outcome score (ADL-BI Scale) in subjects
Time frame: 2,5,12 weeks during treatment
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