Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Running, not enrolling · Not applicable
Conditions studied: Chronic Subdural Hematoma
In brief
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.
Key facts
- Study ID
- NCT07751887
- Run by
- University Hospital Hradec Kralove
- People needed
- 200
- Starts
- 2026-06-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University Hospital Hradec Kralove — Hradec Králové, Czechia
Full record on ClinicalTrials.gov
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