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To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin and Dexamethasone | Experimental | 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) |
|
| Atorvastatin | Active Comparator | Atorvastatin: 20 mg (every evening orally) for 5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 20 mg (every evening orally) for 5 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of hematoma volume | 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. | 2,5,12 weeks during treatment |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongcai Jiang, PhD | Contact | 86-22-60814348 | jianghope@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100029 | China | ||
| Tianjin Medical University General Hospital |
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| Atorvastatin and Dexamethasone |
| Drug |
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) |
|
| 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 |
| Tianjin |
| Tianjin Municipality |
| 300052 |
| China |
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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