Chronic subdural hematoma
Conditions
Interventions
Non-surgical control group:Atorvastatin 20mg QD for 8 weeks
Non-surgical experimental group:Sole middle meningeal artery embolization
Surgical control group:Surgical evacuation
Surgical experimental group:Surgical evacuation followed by adjunct middle meningeal artery embolization
Sponsors
The First Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old; 2. Chronic subdural hematoma with or without acute bleeding signal diagnosed by imaging doctors unrelated to the study; 3. Patients who must have at least one of the following risk factors for hematoma recurrence, including old age (> 80 years old), hemodialysis, anticoagulation or antiplatelet therapy, coagulation dysfunction, severe brain atrophy with significantly widened sulcus and subdural space, bilateral CSDH, separated or separated hematoma, with acute hemorrhage and hematoma recurrence within one month after operation; 4. The patients or their surrogate supervisors fully understand the purpose and needs of this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with acute subdural hemorrhage; 2. Patients with contraindications of angiography (such as pregnant women, previous serious history of contrast agent allergy); 3. Patients with complicated vascular anatomy or dangerous collateral that can not complete the operation of middle meningeal artery embolization; 4. Patients with life expectancy less than 6 months; 5. Patients with potential SDH related diseases or factors, including vascular malformations, brain tumors, arachnoid cysts, spontaneous intracranial hypotension and previous craniotomy history (except drilling); 6. Patients who have used corticosteroids within 1 month or expected to use corticosteroids within the next 6 months; 7. Patients who can not complete all outpatient follow-up 1, 3 and 6 months after treatment; 8. Patients who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematoma enlargement found in serial follow-up CT scan;Substantial residual hematoma in 6-month follow-up CT scan;Surgical rescue for continuous growth of initial hematoma or recurrent hematoma; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS score 1 month after treatment;mRS score 6 month after treatment; | — |
Countries
China
Contacts
Public ContactPan Jianwei
The First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed