Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma

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.

Inclusion Criteria:

1. Age ≥ 18 and <90 years old, male or female;
2. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
3. Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3;
4. 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;
5. Patients have never undergo surgery on the hematoma
6. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion Criteria:

1. Allergic to the statin or its ingredients
2. Cerebral herniation might occur at any time;
3. Hematoma leads to herniation and warrants surgical operation.
4. Hematoma caused by tumors, blood and other known comorbidities;
5. Abnormal liver function
6. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study
7. Patients have been on oral Statin treatment for a long time.
8. Patients have been on oral Steroids treatment for a long time.
9. Participate in clinical trials in the past four weeks;
10. Pregnant or breastfeeding
11. Failure of completing the trial by poor compliance;
12. For any reason, the researchers believe that the case is not suitable for inclusion.