Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

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.

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.