Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

October 24, 2016 updated by: Oriental Neurosurgery Evidence-Based-Study Team

Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General Hospital
      • Beijing, China
        • Peking Union Medical College Hospital
      • Cangzhou, China
        • Cangzhou centerl hospital
      • Changsha, China
        • Xiangya hospital central southe university
      • Chongqing, China
        • Southwest Hospital
      • Chongqing, China
        • West China Hospital
      • Fuzhou, China
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou, China
        • Nanfang Hospital
      • Haerbing, China
        • First Affiliated Hospital of Harbin Medical University
      • Haikou, China
        • Hainan General Hospital
      • Hangzhou, China
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, China
        • 117 Hospital of People's Liberation Army
      • Hefei, China
        • Anhui Provincial Hospital
      • Hohehot, China
        • Inner Mongolia People's Hospital
      • Jinan, China
        • Qilu Hospital of Shandong University
      • Linyi, China
        • Linyi People's Hospital
      • Nanjing, China
        • Jiangsu Province Hospital
      • Ordos, China
        • Ordos Central Hospital
      • Shanghai, China
        • Huashan Hospital
      • Shanghai, China
        • Changzheng hospital
      • Shijiazhuang, China
        • The Second Hospital of Hebei Medical University
      • Taiyuan, China
        • The First Hospital of Shanxi Medical University
      • Wuhan, China
        • Tongji Hospital
      • Xian, China
        • Xijing Hospital
      • Xian, China
        • Tangdu Hospital
      • Xianggang, China
        • Prince of Wales Hospital
      • Xuzhou, China
        • The Affiliated Hospital of Xuzhou Medical College
      • Yinchuan, China
        • General Hospital of Ningxia Medical University
      • Zhengzhou, China
        • The First Affiliated Hospital of Zhengzhou University
    • Beijing
      • Beijing, Beijing, China
        • Beijing Tiantan Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Check on 8 weeks during treatment (at the end)

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
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.
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
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.
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Hematoma Reduced Amount
Time Frame: 4 weeks during treatment, in the follow-up in 12 and 24 weeks.
4 weeks during treatment, in the follow-up in 12 and 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oriental Neurosurgery Evidence-Based-Study Team

Investigators

  • Principal Investigator: Ning jian zhang, MD, PhD, Tianjin Medical University General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

December 25, 2013

First Posted (ESTIMATE)

December 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSDH2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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