Status:
UNKNOWN
The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
Lead Sponsor:
Oriental Neurosurgery Evidence-Based-Study Team
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
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-treate...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02192320
Start Date
July 1 2014
End Date
September 1 2015
Last Update
March 26 2015
Active Locations (2)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
2
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052