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Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

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: NCT02024373
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Oriental Neurosurgery Evidence-Based-Study Team

Brief Summary:
To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).

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

Detailed Description:

Study design:

Multi-center, randomized, double-blind, placebo parallel controlled

Subjects:

Patients with chronic subdural hematoma (CSDH)

Sample size:

200, including an Atorvastatin-treated group of 100 patients and a control group of 100 subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma
Study Start Date : December 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atorvastatin
atorvastatin:20 mg (every evening orally) for 8 weeks
Drug: Atorvastatin
20 mg (every evening orally) for 8 weeks

Placebo Comparator: placebo
placebo:20 mg (every evening orally) for 8 weeks
Drug: placebo
20 mg (every evening orally) for 8 weeks




Primary Outcome Measures :
  1. Hematoma Reduced Amount. [ Time Frame: Check on 8 weeks during treatment (at the end) ]
    The primary efficacy endpoint: hematoma reduced amount. Outcome Measures: all patients underwent head CT (plain scan) before treatment, and check on 8 weeks during treatment (at the end)


Secondary Outcome Measures :
  1. The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects [ Time Frame: 0,7days,4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. ]
  2. Changes of neurological symptoms and signs [ Time Frame: 0,7days,4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. ]
  3. Changes of routine blood test and coagulation results [ Time Frame: 0,7days,4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks. ]
  4. Hematoma Reduced Amount [ Time Frame: 4 weeks during treatment, in the follow-up in 12 and 24 weeks. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and <90 years old, male or female;
  2. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
  3. Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3;
  4. 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;
  5. Patients have never undergo surgery on the hematoma
  6. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion Criteria:

  1. Allergic to the statin or its ingredients
  2. Cerebral herniation might occur at any time;
  3. Hematoma leads to herniation and warrants surgical operation.
  4. Hematoma caused by tumors, blood and other known comorbidities;
  5. Abnormal liver function
  6. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study
  7. Patients have been on oral Statin treatment for a long time.
  8. Patients have been on oral Steroids treatment for a long time.
  9. Participate in clinical trials in the past four weeks;
  10. Pregnant or breastfeeding
  11. Failure of completing the trial by poor compliance;
  12. 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): NCT02024373


Locations
Show Show 31 study locations
Sponsors and Collaborators
Oriental Neurosurgery Evidence-Based-Study Team
Investigators
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Principal Investigator: Ning jian zhang, MD, PhD Tianjin Medical University General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oriental Neurosurgery Evidence-Based-Study Team
ClinicalTrials.gov Identifier: NCT02024373    
Other Study ID Numbers: CSDH2013
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: February 2016
Keywords provided by Oriental Neurosurgery Evidence-Based-Study Team:
chronic subdural hematoma
Atorvastatin
oral administration therapy
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
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
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors