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NCT07751887
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Conditions: Chronic Subdural Hematoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: University Hospital Hradec Kralove
Location: Hospital Ceske Budejovice České Budějovice
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.
Eligibility Criteria
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 \2.0 that cannot be safely corrected before the procedure).
* Severe renal impairment (e.g., eGFR \
Source: ClinicalTrials.gov (NCT07751887). StuddyBuddy aggregates publicly available trial information.