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

NCT ID: NCT02192320

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-09-30

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-treated group, 30 in Atorvastatin-treated group.

Conditions

Chronic Subdural Hematoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Atorvastatin and Dexamethasone

Intervention Type: DRUG

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)

Atorvastatin

Atorvastatin: 20 mg (every evening orally) for 5 weeks

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

20 mg (every evening orally) for 5 weeks

Interventions

Atorvastatin

20 mg (every evening orally) for 5 weeks

Intervention Type: DRUG

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)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oriental Neurosurgery Evidence-Based-Study Team

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Rongcai Jiang, PhD

Role: CONTACT

jianghope@gmail.com

86-22-60814348

Other Identifiers

CSDH2014

Identifier Type: -

Identifier Source: org_study_id