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

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)

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Embolization of MMA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Humain Baharvahdat, MD; Phone Number: +98-915-110-0400; Email: humainbv@yahoo.fr
• Study Contact Backup: Name: Masoud Pishjoo, MD; Phone Number: ‭+98 915 362 8792‬; Email: masoud.pishjoo@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Mashhad, Iran, Islamic Republic of
    • Recruiting
    • Ghaem Hospital, Mashhad University of Medical Sciences
    • Contact: Humain Baharvahdat, MD; Phone Number: +98-915-110-0400; Email: humainbv@yahoo.fr
    • Principal Investigator: Feizollah EBRAHIMNIA, MD
    • Sub-Investigator: Ali SHARIAT-RAZAVI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolization arm; Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil	Procedure: Embolization of MMA; embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil); Other Names: Onyx; Squid; Phil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CSDH regression	Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization	60 dyas

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences
• Investigators: Study Director: Humain Baharvahdat, MD, Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: embolization; chronic subdural hematoma; middle meningeal artery; liquid embolic agent
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: 990631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No