Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    100
  • sponsor
    Mashhad University of Medical Sciences
Updated on 26 January 2021

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)

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.

Details
Condition Chronic subdural hematoma
Treatment Embolization of MMA
Clinical Study IdentifierNCT04574843
SponsorMashhad University of Medical Sciences
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic subdural hematoma?
Do you have any of these conditions: Do you have Chronic subdural hematoma??
patients diagnosed chronic or subacute subdural hematoma
Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness
Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment

Exclusion Criteria

presentation with coma (GCS =< 8)
patients needs emergent evacuation of hematoma
patients could not participate in 60 days follow-up
pregnant patients
acute subdural hematoma
contraindication to contrast
contradiction to angiography
difficult access to MMA due to anatomical variation
contraindication to liquid embolic agent
unmanaged/uncontrollable bleeding disorders
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