Chronic subdural Hematoma
Conditions
Interventions
ATO group:Received Atorvastatin (20mg per day) and Dexamethasone placebo (0.75mg tid for 2 weeks, bid for 1 week, qd for 1 week), total 4 weeks treatment
ATO+DXM group:Received Atorvastatin (20mg per day) and Dexamethasone (0.75mg tid for 2 weeks, bid for 1 week, qd for 1 week), total 4 weeks treatment
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 90 years old, male and female; 2. Within 72 hours before enrollment in the experiment, CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); a single unilateral hematoma should be greater than 10ml; 3. Modified Rankin Scale (mRS) 1~3 Grade (including 1 and 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 undergone surgery on the chronic subdural hematoma; 6. Patients fully understood the nature of the study, and voluntarily participates and signs informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic to the statin, Glucocorticoid or its ingredients; 2. Cerebral herniation might occur at any time or highly suspected severe hernia, and surgery must be performed to exclude dangerous situation; 3. Hematoma caused by tumors, hematologic diseases, Tuberculous, arachnoid cyst, vascular malformation, ventricular peritoneal shunt or other known severe comorbidities; 4. Abnormal liver function, hepatitis or uncontrolled liver diseases, as well as suffering from other disease may interfere the study; 5. Severe cardiac, pulmonary, hepatic and renal dysfunction were observed before admission, which affected the prognosis of the patients; 6. Diabetes with poorly controlled, blood glucose continues to exceed 10mmol/L; 7. Have a history of femoral head necrosis with no surgery; 8. In the past 4 weeks, patients with a history of oral statins or allergic reactions to statins were present; 9. In the past 4 weeks, patients with a history of using steroid hormone; 10. In the past 4 weeks, patients have been on anticoagulants such as warfarin or obviously abnormal coagulation function; 11. Participate in other clinical trials in the past four weeks; 12. Pregnant or breastfeeding; 13. Failure of completing the trial by poor compliance; 14. For any reason, the researchers believe that the case is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Activities of daily living-Barthel index;Modified Rankin Scale;The proportion of patients need swith to surgical intervention;Reduction rate of hematoma; | — |
Countries
China
Contacts
Public ContactZhang Jianning
Tianjin Medical University General Hospital
Outcome results
None listed