Middle Meningeal Artery Embolisation to Prevent Recurrence of Chronic Subdural Hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international multicenter study investigates the safety and potential benefit of middle meningeal artery embolization (MMAE) using either polyvinyl alcohol particles or liquid embolic agents as a perioperative step for patients with chronic subdural hematoma. All eligible participants undergo MMAE within 7 days before or after surgical evacuation, with follow-up focused on hematoma recurrence and procedure-related complications over 90 days. The trial includes adults with symptomatic or asymptomatic cSDH who meet imaging criteria and are planned for conservative management or standard evacuation. Enrollment is conducted across three Czech and Slovak centers under a non-randomized, interventional framework. Primary outcomes center on recurrence rates and safety in the perioperative period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Ceske Budejovice
  České Budějovice, Czechia Recruiting
• University Hospital Hradec Kralove
  Hradec Králové, Czechia Recruiting
• Hospital Liberec
  Liberec, Czechia Recruiting
• University Hospital Olomouc
  Olomouc, Czechia Recruiting
• The Military University Hospital Prague
  Prague, Czechia Recruiting
• University Hospital Motol and Homolka
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: David Brustman
• Email: david.brustman@fnhk.cz
• Phone: +420723419588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.