Chronic Subdural Hematoma
Conditions
Keywords
Chronic subdural hematoma, embolisation, MMAE, reccurence, hematoma evacuation
Brief summary
This international multicenter study evaluates the efficacy and safety of middle meningeal artery embolization (MMAE) using PVA particles or liquid embolic agents as a perioperative treatment to prevent the recurrence of chronic subdural hematoma (cSDH). All participating patients across centers in the Czech Republic and Slovakia will receive the minimally invasive MMAE procedure within 7 days prior to or after surgical evacuation, with the primary goal of assessing hematoma recurrence rates and procedure-related complications over a 90-day follow-up period.
Interventions
DEVICEMiddle Meningeal Artery Embolisation
Endovascular occlusion of the middle meningeal artery (MMA) performed under fluoroscopic guidance. The procedure aims to devascularize the chronic subdural hematoma membrane to promote hematoma resorption and prevent recurrence.
Sponsors
University Hospital Hradec Kralove
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Diagnosis of a symptomatic or asymptomatic chronic or subacute subdural hematoma (cSDH) confirmed by neuroimaging (CT or MRI). * Hematoma thickness of 5 mm or greater at its widest point on baseline neuroimaging. * Patient is managed either conservatively or via standard surgical evacuation (e.g., burr-hole craniostomy) where MMAE is planned as a standalone or adjunctive treatment. * Written informed consent provided by the patient or a legally authorized representative.
Exclusion criteria
* Acute subdural hematoma requiring emergency surgical decompression due to severe neurological deficit with signs of impending herniation. * Evidence of an active intracranial infection or sepsis. * Known vascular malformation, aneurysm, or dural arteriovenous fistula as the source of the hematoma. * Severe uncorrectable coagulopathy or bleeding disorder (e.g., platelet count \<50,000/µL or INR \>2.0 that cannot be safely corrected before the procedure). * Severe renal impairment (e.g., eGFR \<30 mL/min/1.73m²) or known severe allergy to iodinated contrast media (unless adequate premedication is possible). * Life expectancy of less than 3 months due to severe comorbid conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hematoma recurrence or treatment failure requiring surgical evacuation | Up to 90 days post-enrollment. | The proportion of participants who experience a symptomatic or radiologically confirmed recurrence or progression of chronic subdural hematoma (cSDH) in the target hemisphere that requires surgical intervention (or re-operation for surgically treated patients) within the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of periprocedural and postprocedural complications | During hospitalization, up to 7 days post-procedure | Safety outcomes evaluating complications related to the middle meningeal artery embolisation (MMAE) procedure or the embolic material. This includes technical failure, ischemic stroke, new intracranial hemorrhage, facial nerve palsy, visual impairment, local arterial access site complications (e.g., hematoma, pseudoaneurysm), or severe allergic reactions to contrast media. |
Countries
Czechia
Outcome results
None listed