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The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders

Primary Purpose

Chronic Subdural Hematoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin and Dexamethasone
Sponsored by
Oriental Neurosurgery Evidence-Based-Study Team
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Atorvastatin, Atorvastatin and Dexamethasone, Chronic Subdural Hematoma, conservative treatment

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 and<90years old, both gender;
  2. Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;
  3. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
  4. The midline shift to less than 1 cm;
  5. 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;
  6. Patients have never undergo surgery on the hematoma;
  7. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion Criteria:

  1. Allergic to the statin and dexamethasone or its ingredients;
  2. Hematoma caused by tumors, blood and other known comorbidities;
  3. Abnormal liver function;
  4. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study;
  5. Patients have been on oral Statin treatment in the past four weeks;
  6. Patients have been on oral Steroids treatment for a long time;
  7. Diagnosed Diabetes patients with poorly controlled blood glucose
  8. Participate in clinical trials in the past four weeks;
  9. Pregnant or breastfeeding;
  10. Failure of completing the trial by poor compliance;
  11. For any reason, the researchers believe that the case is not suitable for inclusion.

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atorvastatin and Dexamethasone

Atorvastatin

Arm Description

Atorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone: 0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)

Atorvastatin: 20 mg (every evening orally) for 5 weeks

Outcomes

Primary Outcome Measures

Changes of hematoma volume
After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.

Secondary Outcome Measures

Outcome score (GOSE) in subjects
Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis
Changes of neurological symptoms and signs
Recurrence and prognosis of patient failure in those conservative treatment
Outcome score (ADL-BI Scale) in subjects

Full Information

First Posted
July 11, 2014
Last Updated
March 25, 2015
Sponsor
Oriental Neurosurgery Evidence-Based-Study Team
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1. Study Identification

Unique Protocol Identification Number
NCT02192320
Brief Title
The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
Official Title
The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oriental Neurosurgery Evidence-Based-Study Team

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
Detailed Description
Study design: Two-arm,Evaluator-blinded study Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted） Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
Atorvastatin, Atorvastatin and Dexamethasone, Chronic Subdural Hematoma, conservative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin and Dexamethasone
Arm Type
Experimental
Arm Description
Atorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone: 0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Atorvastatin: 20 mg (every evening orally) for 5 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
20 mg (every evening orally) for 5 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin and Dexamethasone
Intervention Description
Atorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)
Primary Outcome Measure Information:
Title
Changes of hematoma volume
Description
After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.
Time Frame
2,5,12 weeks during treatment
Secondary Outcome Measure Information:
Title
Outcome score (GOSE) in subjects
Time Frame
2,5,12 weeks during treatment
Title
Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis
Time Frame
2,5,12 weeks during treatment
Title
Changes of neurological symptoms and signs
Time Frame
2,5,12 weeks during treatment
Title
Recurrence and prognosis of patient failure in those conservative treatment
Time Frame
2,5,12 weeks during treatment
Title
Outcome score (ADL-BI Scale) in subjects
Time Frame
2,5,12 weeks during treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 and<90years old, both gender; Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders; CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); The midline shift to less than 1 cm; 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; Patients have never undergo surgery on the hematoma; Patient fully understood the nature of the study, and voluntarily participates and signs informed consent. Exclusion Criteria: Allergic to the statin and dexamethasone or its ingredients; Hematoma caused by tumors, blood and other known comorbidities; Abnormal liver function; Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study; Patients have been on oral Statin treatment in the past four weeks; Patients have been on oral Steroids treatment for a long time; Diagnosed Diabetes patients with poorly controlled blood glucose Participate in clinical trials in the past four weeks; Pregnant or breastfeeding; Failure of completing the trial by poor compliance; For any reason, the researchers believe that the case is not suitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongcai Jiang, PhD
Phone
86-22-60814348
Email
jianghope@gmail.com
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China

12. IPD Sharing Statement

Learn more about this trial

The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders

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