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

Chronic Subdural Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02192320
• Other study ID #: CSDH2014
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 11, 2014
• Last updated: March 25, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2015
• Source: Oriental Neurosurgery Evidence-Based-Study Team
• Contact: Rongcai Jiang, PhD
• Phone: 86-22-60814348
• Email: jianghope[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders

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-treated group, 30 in Atorvastatin-treated group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic
• Hemostatic Disorders

Intervention

Drug:
• Atorvastatin
20 mg (every evening orally) for 5 weeks
• Atorvastatin and Dexamethasone
Atorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Oriental Neurosurgery Evidence-Based-Study Team

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of hematoma volume	After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.	2,5,12 weeks during treatment	No
Secondary	Outcome score (GOSE) in subjects		2,5,12 weeks during treatment	No
Secondary	Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis		2,5,12 weeks during treatment	No
Secondary	Changes of neurological symptoms and signs		2,5,12 weeks during treatment	No
Secondary	Recurrence and prognosis of patient failure in those conservative treatment		2,5,12 weeks during treatment	No
Secondary	Outcome score (ADL-BI Scale) in subjects		2,5,12 weeks during treatment	No