Clinical trial NCT02192320: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Subdural Hematoma
Keywords: Atorvastatin
Atorvastatin and Dexamethasone
Chronic Subdural Hematoma
conservative treatment
Lead sponsor: Oriental Neurosurgery Evidence-Based-Study Team
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of hematoma volume
timeFrame: 2,5,12 weeks during treatment
Secondary outcomes:
measure: Outcome score (GOSE) in subjects
timeFrame: 2,5,12 weeks during treatment
measure: Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis
timeFrame: 2,5,12 weeks during treatment
measure: Changes of neurological symptoms and signs
timeFrame: 2,5,12 weeks during treatment
measure: Recurrence and prognosis of patient failure in those conservative treatment
timeFrame: 2,5,12 weeks during treatment
measure: Outcome score (ADL-BI Scale) in subjects
timeFrame: 2,5,12 weeks during treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References: