Overview
The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
Status:
Unknown status
Unknown status
Trial end date:
2015-09-01
2015-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation DisordersPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Oriental Neurosurgery Evidence-Based-Study TeamTreatments:
Atorvastatin
Atorvastatin Calcium
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
Inclusion Criteria:1. Age ≥18 and<90years old, both gender;
2. Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;
3. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI
scan is warranted if diagnosis is difficult);
4. The midline shift to less than 1 cm;
5. 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;
6. Patients have never undergo surgery on the hematoma;
7. Patient fully understood the nature of the study, and voluntarily participates and
signs informed consent.
Exclusion Criteria:
1. Allergic to the statin and dexamethasone or its ingredients;
2. Hematoma caused by tumors, blood and other known comorbidities;
3. Abnormal liver function;
4. Uncontrolled hepatitis and other liver diseases, as well as suffering from other
disease may interfere the study;
5. Patients have been on oral Statin treatment in the past four weeks;
6. Patients have been on oral Steroids treatment for a long time;
7. Diagnosed Diabetes patients with poorly controlled blood glucose
8. Participate in clinical trials in the past four weeks;
9. Pregnant or breastfeeding;
10. Failure of completing the trial by poor compliance;
11. For any reason, the researchers believe that the case is not suitable for inclusion.