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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Atorvastatin and Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and<90years old, both gender; Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders; CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); The midline shift to less than 1 cm; 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; Patients have never undergo surgery on the hematoma; Patient fully understood the nature of the study, and voluntarily participates and signs informed consent. Exclusion Criteria: Allergic to the statin and dexamethasone or its ingredients; Hematoma caused by tumors, blood and other known comorbidities; Abnormal liver function; Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study; Patients have been on oral Statin treatment in the past four weeks; Patients have been on oral Steroids treatment for a long time; Diagnosed Diabetes patients with poorly controlled blood glucose Participate in clinical trials in the past four weeks; Pregnant or breastfeeding; Failure of completing the trial by poor compliance; For any reason, the researchers believe that the case is not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin and Dexamethasone<br>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) | Drug: Atorvastatin and Dexamethasone<br>* 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)<br>|
| Active Comparator: Atorvastatin<br>Atorvastatin: 20 mg (every evening orally) for 5 weeks | Drug: Atorvastatin<br>* 20 mg (every evening orally) for 5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atorvastatin, Atorvastatin and Dexamethasone, Chronic Subdural Hematoma, conservative treatment