Chronic Subdural Hematoma
Conditions
Keywords
Atorvastatin, Atorvastatin and Dexamethasone, Chronic Subdural Hematoma, conservative treatment
Brief summary
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
Detailed description
Study design: Two-arm,Evaluator-blinded study Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted） Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.
Interventions
DRUGAtorvastatin
20 mg (every evening orally) for 5 weeks
DRUGAtorvastatin and Dexamethasone
Atorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)
Sponsors
Oriental Neurosurgery Evidence-Based-Study Team
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of hematoma volume | 2,5,12 weeks during treatment | After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up. |
Secondary
| Measure | Time frame |
|---|---|
| Outcome score (GOSE) in subjects | 2,5,12 weeks during treatment |
| Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis | 2,5,12 weeks during treatment |
| Changes of neurological symptoms and signs | 2,5,12 weeks during treatment |
| Recurrence and prognosis of patient failure in those conservative treatment | 2,5,12 weeks during treatment |
| Outcome score (ADL-BI Scale) in subjects | 2,5,12 weeks during treatment |
Countries
China
Contacts
Primary ContactRongcai Jiang, PhD
Outcome results
None listed