Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

Chronic Subdural Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024373
• Other study ID #: CSDH2013
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2013
• Last updated: October 24, 2016
• Start date: December 2013
• Est. completion date: September 2016

Study information

• Verified date: February 2016
• Source: Oriental Neurosurgery Evidence-Based-Study Team
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Atorvastatin
20 mg (every evening orally) for 8 weeks
• placebo
20 mg (every evening orally) for 8 weeks

Locations

Country	Name	City	State
China	Beijing tiantan hospital	Beijing	Beijing
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	Tianjin Medical University General Hospital	Tianjin	Tianjin
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

Sponsors (1)

Lead Sponsor	Collaborator
Oriental Neurosurgery Evidence-Based-Study Team

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma Reduced Amount.	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)	No
Secondary	The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects		0,7days,4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.	No
Secondary	Changes of neurological symptoms and signs		0,7days,4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.	No
Secondary	Changes of routine blood test and coagulation results		0,7days,4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.	No
Secondary	Hematoma Reduced Amount		4 weeks during treatment, in the follow-up in 12 and 24 weeks.	No