Chronic Subdural Hematoma
Conditions
Keywords
chronic subdural hematoma, embolization, middle meningeal artery, liquid embolic agent
Brief summary
The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)
Detailed description
This study is a prospective one arm trial designed to assess the safety and efficacy of MMA embolization with liquid embolic agents (onyx/squid/Phil) as the main treatment of CSDH. The subjects are enrolled in the study according to inclusion and exclusion criteria. Imaging and clinical presentations of patients are recorded. Within 48 hours of embolization, patients are assessed with clinical examination and with a brain CT scan to evaluate in any change in their symptoms and CSDH volume. 2-4 weeks after embolization, patients are evaluated in clinic for any change in their symptoms and signs. 60 days after embolization patients are examined clinically and are assessed for SDH volume change in CT scan and MRI. If there is any significant increase in CSDH volume or any deterioration of patient, evacuation of hematoma is considered. MMA embolization is performed under general anesthesia using biplane or monoplane angiography. Femoral or radial accesses are used. Guiding catheter is advanced into external carotid artery in corresponding side. The corresponding MMA is catheterized distally by micro-catheter and is embolized by liquid embolic agents. Patients are discharge next day if they are stable.
Interventions
PROCEDUREEmbolization of MMA
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients diagnosed chronic or subacute subdural hematoma 2. Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ... 3. Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment
Exclusion criteria
1. presentation with coma (GCS =\< 8) 2. patients needs emergent evacuation of hematoma, 3. patients could not participate in 60 days follow-up 4. pregnant patients 5. acute subdural hematoma 6. contraindication to contrast 7. contradiction to angiography 8. difficult access to MMA due to anatomical variation 9. contraindication to liquid embolic agent 10. unmanaged/uncontrollable bleeding disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CSDH regression | 60 dyas | Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CSDH progression or recurrence | 60 days | Increase in volume of CSDH |
| Incidence of new neurological deficit (ND) | 60 days | ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia |
| incidence of Death | 60 days | — |
| Incidence of myocardial infarction/myocardial ischemia | 60 days | new ischemic heart attack within 60 days of operation |
| Incidence of embolization complication in brain | 48 hours | cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ... |
| incidence of embolization complication out of brain | 15 days | puncture hematoma, major artery dissection, new renal failure, ... |
| Incidence of new ischemic stroke | 60 days | new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation |
Countries
Iran
Contacts
Primary ContactHumain Baharvahdat, MD
Backup ContactMasoud Pishjoo, MD
Outcome results
None listed