Chronic Subdural Hematoma
Conditions
Keywords
chronic subdural hematoma, Atorvastatin, oral administration therapy
Brief summary
To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).
Detailed description
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.
Interventions
DRUGAtorvastatin
20 mg (every evening orally) for 8 weeks
DRUGplacebo
20 mg (every evening orally) for 8 weeks
Sponsors
Oriental Neurosurgery Evidence-Based-Study Team
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and \<90 years old, male or female; 2. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); 3. Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)\<Grade 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 undergo surgery on the hematoma 6. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.
Exclusion criteria
1. Allergic to the statin or its ingredients 2. Cerebral herniation might occur at any time; 3. Hematoma leads to herniation and warrants surgical operation. 4. Hematoma caused by tumors, blood and other known comorbidities; 5. Abnormal liver function 6. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study 7. Patients have been on oral Statin treatment for a long time. 8. Patients have been on oral Steroids treatment for a long time. 9. Participate in clinical trials in the past four weeks; 10. Pregnant or breastfeeding 11. Failure of completing the trial by poor compliance; 12. For any reason, the researchers believe that the case is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma Reduced Amount. | Check on 8 weeks during treatment (at the end) | 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) |
Secondary
| Measure | 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. |
Countries
China
Outcome results
None listed