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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Drug: Atorvastatin Drug: Atorvastatin and Dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
Study Start Date : July 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Outcome score (GOSE) in subjects [ Time Frame: 2,5,12 weeks during treatment ]
  2. Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis [ Time Frame: 2,5,12 weeks during treatment ]
  3. Changes of neurological symptoms and signs [ Time Frame: 2,5,12 weeks during treatment ]
  4. Recurrence and prognosis of patient failure in those conservative treatment [ Time Frame: 2,5,12 weeks during treatment ]
  5. Outcome score (ADL-BI Scale) in subjects [ Time Frame: 2,5,12 weeks during treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192320


Contacts
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Contact: Rongcai Jiang, PhD 86-22-60814348 jianghope@gmail.com

Locations
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China, Beijing
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing, China, 100029
China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300052
Sponsors and Collaborators
Oriental Neurosurgery Evidence-Based-Study Team
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Responsible Party: Oriental Neurosurgery Evidence-Based-Study Team
ClinicalTrials.gov Identifier: NCT02192320    
Other Study ID Numbers: CSDH2014
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Keywords provided by Oriental Neurosurgery Evidence-Based-Study Team:
Atorvastatin
Atorvastatin and Dexamethasone
Chronic Subdural Hematoma
conservative treatment
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hemostatic Disorders
Blood Coagulation Disorders
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Hematologic Diseases
Hemorrhagic Disorders
Dexamethasone
Atorvastatin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones