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

March 25, 2015 updated by: Oriental Neurosurgery Evidence-Based-Study Team
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital, Capital Medical University
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)
Active Comparator: Atorvastatin
Atorvastatin: 20 mg (every evening orally) for 5 weeks
Drug: Atorvastatin
20 mg (every evening orally) for 5 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2,5,12 weeks during treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Outcome score (GOSE) in subjects
Time Frame: 2,5,12 weeks during treatment
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
2,5,12 weeks during treatment
Changes of neurological symptoms and signs
Time Frame: 2,5,12 weeks during treatment
2,5,12 weeks during treatment
Recurrence and prognosis of patient failure in those conservative treatment
Time Frame: 2,5,12 weeks during treatment
2,5,12 weeks during treatment
Outcome score (ADL-BI Scale) in subjects
Time Frame: 2,5,12 weeks during treatment
2,5,12 weeks during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oriental Neurosurgery Evidence-Based-Study Team

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSDH2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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