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

• ClinicalTrials.gov Identifier: NCT02192320
• Recruitment Status: Unknown
• First Posted: July 16, 2014
• Last Update Posted: March 26, 2015
• Sponsor: Oriental Neurosurgery Evidence-Based-Study Team
• Information provided by (Responsible Party): Oriental Neurosurgery Evidence-Based-Study Team

Tracking Information

• First Submitted Date: July 11, 2014
• First Posted Date: July 16, 2014
• Last Update Posted Date: March 26, 2015
• Study Start Date: July 2014
• Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2014)

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

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2014)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
• Official Title: The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Subdural Hematoma

Intervention

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

Study Arms

• Experimental: 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: Drug: Atorvastatin and Dexamethasone
• Active Comparator: Atorvastatin
  Atorvastatin: 20 mg (every evening orally) for 5 weeks
  Intervention: Drug: Atorvastatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 14, 2014): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2015
• Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02192320
• Other Study ID Numbers: CSDH2014
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Oriental Neurosurgery Evidence-Based-Study Team
• Study Sponsor: Oriental Neurosurgery Evidence-Based-Study Team
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Oriental Neurosurgery Evidence-Based-Study Team
• Verification Date: March 2015