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

Chronic Subdural Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04574843
• Other study ID #: 990631
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: Mashhad University of Medical Sciences
• Contact: Humain Baharvahdat, MD
• Phone: +98-915-110-0400
• Email: humainbv[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Embolization of MMA
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ghaem Hospital, Mashhad University of Medical Sciences	Mashhad

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CSDH regression	Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization	60 dyas
Secondary	Incidence of CSDH progression or recurrence	Increase in volume of CSDH	60 days
Secondary	Incidence of new neurological deficit (ND)	ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia	60 days
Secondary	incidence of Death		60 days
Secondary	Incidence of new ischemic stroke	new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation	60 days
Secondary	Incidence of myocardial infarction/myocardial ischemia	new ischemic heart attack within 60 days of operation	60 days
Secondary	Incidence of embolization complication in brain	cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ...	48 hours
Secondary	incidence of embolization complication out of brain	puncture hematoma, major artery dissection, new renal failure, ...	15 days