Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oriental Neurosurgery Evidence-Based-Study Team
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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)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.