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

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ClinicalTrials.gov Identifier: NCT02192320
Recruitment Status : Unknown
Verified March 2015 by Oriental Neurosurgery Evidence-Based-Study Team.
Recruitment status was:  Not yet recruiting
First Posted : July 16, 2014
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Oriental Neurosurgery Evidence-Based-Study Team

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 16, 2014
Last Update Posted Date March 26, 2015
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 14, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02192320
Other Study ID Numbers  ICMJE CSDH2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oriental Neurosurgery Evidence-Based-Study Team
Study Sponsor  ICMJE Oriental Neurosurgery Evidence-Based-Study Team
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oriental Neurosurgery Evidence-Based-Study Team
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP