Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

Study Overview
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Brief Summary
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To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).

Detailed Description
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Study design: Multi-center, randomized, double-blind, placebo parallel controlled Subjects: Patients with chronic subdural hematoma (CSDH) Sample size: 200, including an Atorvastatin-treated group of 100 patients and a control group of 100 subjects.

Official Title
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Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and <90 years old, male or female; CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3; 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 or its ingredients Cerebral herniation might occur at any time; Hematoma leads to herniation and warrants surgical operation. 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 for a long time. Patients have been on oral Steroids treatment for a long time. 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: 90 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>atorvastatin：20 mg (every evening orally) for 8 weeks | Drug: Atorvastatin<br>* 20 mg (every evening orally) for 8 weeks<br>|
| Placebo Comparator: placebo<br>placebo:20 mg (every evening orally) for 8 weeks | Drug: placebo<br>* 20 mg (every evening orally) for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematoma Reduced Amount. | The primary efficacy endpoint: hematoma reduced amount. Outcome Measures: all patients underwent head CT (plain scan) before treatment, and check on 8 weeks during treatment (at the end) | Check on 8 weeks during treatment (at the end) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects |  | 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. | 
| Changes of neurological symptoms and signs |  | 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. | 
| Changes of routine blood test and coagulation results |  | 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. | 
| Hematoma Reduced Amount |  | 4 weeks during treatment, in the follow-up in 12 and 24 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic subdural hematoma, Atorvastatin, oral administration therapy