The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders

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

Details

• Lead Sponsor: Oriental Neurosurgery Evidence-Based-Study Team
• Treatments: Atorvastatin; Atorvastatin Calcium; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

1. Age ≥18 and<90years old, both gender;

2. Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;

3. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);

4. The midline shift to less than 1 cm;

5. 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;

6. Patients have never undergo surgery on the hematoma;

7. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion Criteria:

1. Allergic to the statin and dexamethasone or its ingredients;

2. Hematoma caused by tumors, blood and other known comorbidities;

3. Abnormal liver function;

4. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study;

5. Patients have been on oral Statin treatment in the past four weeks;

6. Patients have been on oral Steroids treatment for a long time;

7. Diagnosed Diabetes patients with poorly controlled blood glucose

8. Participate in clinical trials in the past four weeks;

9. Pregnant or breastfeeding;

10. Failure of completing the trial by poor compliance;

11. For any reason, the researchers believe that the case is not suitable for inclusion.