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

Oriental Neurosurgery Evidence-Based-Study Team

Status and phase: Unknown; Phase 2

Conditions: Chronic Subdural Hematoma

Treatments: Drug: Atorvastatin and Dexamethasone; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02192320

CSDH2014

Details and patient eligibility

About

To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Atorvastatin and Dexamethasone

Experimental group

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)

Treatment:

Drug: Atorvastatin and Dexamethasone

Atorvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin