Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oriental Neurosurgery Evidence-Based-Study Team
ClinicalTrials.gov Identifier:
NCT02024373
First received: August 7, 2013
Last updated: February 29, 2016
Last verified: February 2016
  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 2

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 12 and 24 weeks. ] [ 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 12 and 24 weeks. ] [ 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 12 and 24 weeks. ] [ Designated as safety issue: No ]
  • Hematoma Reduced Amount [ Time Frame: 4 weeks during treatment, in the follow-up in 12 and 24 weeks. ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: April 2016 (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. 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.
  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

Locations
China, Beijing
Beijing tiantan hospital
Beijing, Beijing, China
China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300052
China
Chinese PLA General Hospital
Beijing, China
Peking union medical college hospital
Beijing, China
Cangzhou centerl hospital
Cangzhou, China
Xiangya hospital central southe university
Changsha, China
Southwest hospital
Chongqing, China
West china hospital
Chongqing, China
The first affiliated hospital of Fujian medical university
Fuzhou, China
Nanfang hospital
Guangzhou, China
First Affiliated Hospital of Harbin Medical University
Haerbing, China
Hainan general hospital
Haikou, China
117 Hospital of People's Liberation Army
Hangzhou, China
The second Affiliated hospital of zhejiang university school of medicine
Hangzhou, China
Anhui provincial hospital
Hefei, China
Inner mongolia people's hospital
Hohehot, China
Qilu hospital of shandong university
Jinan, China
Linyi People's Hospital
Linyi, China
Jiangsu province hospital
Nanjing, China
Ordos Central Hospital
Ordos, China
Changzheng Hospital
Shanghai, China
Huashan hospital
Shanghai, China
The second hospital of Hebei medical university
Shijiazhuang, China
The first hospital of Shanxi medical university
Taiyuan, China
Tongji hospital
Wuhan, China
Tangdu hospital
Xian, China
Xijing Hospital
Xian, China
Prince of Wales Hospital
Xianggang, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China
General Hospital of Ningxia Medical University
Yinchuan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: February 29, 2016
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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Hemorrhage
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 05, 2016