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

Phase 2

• Conditions: Chronic Subdural Hematoma
• Interventions: Drug: Atorvastatin and Dexamethasone; Drug: Atorvastatin

• Registration Number: NCT02192320
• Lead Sponsor: Oriental Neurosurgery Evidence-Based-Study Team

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin and Dexamethasone	Atorvastatin and Dexamethasone	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	Atorvastatin	Atorvastatin: 20 mg (every evening orally) for 5 weeks

Primary Outcome Measures

Name	Time	Method
Changes of hematoma volume	2,5,12 weeks during treatment	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

Name	Time	Method
Outcome score (GOSE) in subjects	2,5,12 weeks during treatment
Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis	2,5,12 weeks during treatment
Changes of neurological symptoms and signs	2,5,12 weeks during treatment
Recurrence and prognosis of patient failure in those conservative treatment	2,5,12 weeks during treatment
Outcome score (ADL-BI Scale) in subjects	2,5,12 weeks during treatment

Trial Locations

Locations (2)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China