Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Oriental Neurosurgery Evidence-Based-Study Team
Sponsor:
Information provided by (Responsible Party):
Oriental Neurosurgery Evidence-Based-Study Team
ClinicalTrials.gov Identifier:
NCT02024373
First received: August 7, 2013
Last updated: December 25, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Chronic Subdural Hematoma
Drug: Atorvastatin
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Oriental Neurosurgery Evidence-Based-Study Team:

Primary Outcome Measures:
  • Hematoma Reduced Amount. [ Time Frame: Check on 8 weeks during treatment (at the end) ] [ Designated as safety issue: No ]
    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:
  • 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 3 and 6 months. ] [ Designated as safety issue: No ]
  • Changes of neurological symptoms and signs [ Time Frame: 0,7days,4, 8weeks during treatment (at the end), in the follow-up in 3 and 6 months. ] [ Designated as safety issue: No ]
  • Changes of routine blood test and coagulation results [ Time Frame: 0,7days,4, 8weeks during treatment (at the end), in the follow-up in 3 and 6 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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. In the past a year, patients have been on anti-platelet or warfarin
  10. Participate in clinical trials in the past four weeks;
  11. Pregnant or breastfeeding
  12. Failure of completing the trial by poor compliance;
  13. For any reason, the researchers believe that the case is not suitable for inclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024373

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

Locations
China, Beijing
Beijing tiantan hospital Not yet recruiting
Beijing, Beijing, China
China, Tianjin
Tianjin Medical University General Hospital Not yet recruiting
Tianjin, Tianjin, China, 300052
Contact: Rongcai Jiang, MD, PhD    86-22-60814348    jianghope@gmail.com   
Principal Investigator: Jianning Zhang, MD, PhD         
China
Peking union medical college hospital Not yet recruiting
Beijing, China
Chinese PLA General Hospital Not yet recruiting
Beijing, China
Xiangya hospital central southe university Not yet recruiting
Changsha, China
Southwest hospital Not yet recruiting
Chongqing, China
West china hospital Not yet recruiting
Chongqing, China
First Affiliated Hospital of Harbin Medical University Not yet recruiting
Haerbing, China
The second Affiliated hospital of zhejiang university school of medicine Not yet recruiting
Hangzhou, China
Qilu hospital of shandong university Not yet recruiting
Jinan, China
Changzheng Hospital Not yet recruiting
Shanghai, China
Huashan hospital Not yet recruiting
Shanghai, China
Xijing Hospital Not yet recruiting
Xian, China
Prince of Wales Hospital Not yet recruiting
Xianggang, China
Sponsors and Collaborators
Oriental Neurosurgery Evidence-Based-Study Team
Investigators
Principal Investigator: Ning jian zhang, MD, PhD Tianjin Medical University General Hospital
  More Information

No publications provided

Responsible Party: Oriental Neurosurgery Evidence-Based-Study Team
ClinicalTrials.gov Identifier: NCT02024373     History of Changes
Other Study ID Numbers: CSDH2013
Study First Received: August 7, 2013
Last Updated: December 25, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Oriental Neurosurgery Evidence-Based-Study Team:
chronic subdural hematoma
Atorvastatin
oral administration therapy

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014