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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT02192320
• Date of registration: 11/07/2014
• Prospective Registration: No
• Primary sponsor: Oriental Neurosurgery Evidence-Based-Study Team
• Public title: The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
• Scientific title: The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
• Date of first enrolment: July 2014
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02192320
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Rongcai Jiang, PhD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 89 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Subdural Hematoma

Intervention(s)

Drug: Atorvastatin

Drug: Atorvastatin and Dexamethasone

Primary Outcome(s)

Changes of hematoma volume [Time Frame: 2,5,12 weeks during treatment]

Secondary Outcome(s)

Outcome score (GOSE) in subjects [Time Frame: 2,5,12 weeks during treatment]

Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis [Time Frame: 2,5,12 weeks during treatment]

Changes of neurological symptoms and signs [Time Frame: 2,5,12 weeks during treatment]

Recurrence and prognosis of patient failure in those conservative treatment [Time Frame: 2,5,12 weeks during treatment]

Outcome score (ADL-BI Scale) in subjects [Time Frame: 2,5,12 weeks during treatment]

Secondary ID(s)

CSDH2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors