Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

Oriental Neurosurgery Evidence-Based-Study Team

Status and phase: Completed; Phase 2

Conditions: Chronic Subdural Hematoma

Treatments: Drug: placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02024373

CSDH2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

atorvastatin：20 mg (every evening orally) for 8 weeks

Treatment:

Drug: Atorvastatin

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo