Clinical trial NCT04574843: Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
Official title: Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: chronic subdural hematoma
embolization
middle meningeal artery
liquid embolic agent
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. patients diagnosed chronic or subacute subdural hematoma
2. Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ...
3. Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment

Exclusion Criteria:

1. presentation with coma (GCS =\< 8)
2. patients needs emergent evacuation of hematoma,
3. patients could not participate in 60 days follow-up
4. pregnant patients
5. acute subdural hematoma
6. contraindication to contrast
7. contradiction to angiography
8. difficult access to MMA due to anatomical variation
9. contraindication to liquid embolic agent
10. unmanaged/uncontrollable bleeding disorders

Primary outcomes:
measure: Incidence of CSDH regression
timeFrame: 60 dyas
Secondary outcomes:
measure: Incidence of CSDH progression or recurrence
timeFrame: 60 days
measure: Incidence of new neurological deficit (ND)
timeFrame: 60 days
measure: incidence of Death
timeFrame: 60 days
measure: Incidence of new ischemic stroke
timeFrame: 60 days
measure: Incidence of myocardial infarction/myocardial ischemia
timeFrame: 60 days
measure: Incidence of embolization complication in brain
timeFrame: 48 hours
measure: incidence of embolization complication out of brain
timeFrame: 15 days
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Ghaem Hospital, Mashhad University of Medical Sciences
Study officials:
affiliation: Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran
name: Humain Baharvahdat, MD
role: STUDY_DIRECTOR
References: