NCT04095819

Brief Summary

Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2022

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

September 9, 2019

Last Update Submit

September 17, 2019

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

  • Change in size of SDH

    Changes in size of SDH will be recorded in maximum diameter within 6 months.

    6 months

Secondary Outcomes (1)

  • Change in Neurological status

    6 months

Study Arms (2)

Middle Meningeal Artery Embolization

EXPERIMENTAL

Middle Meningeal Artery Embolization

Procedure: Middle Meningeal Artery procedure

Traditional Surgery

ACTIVE COMPARATOR

Craniotomy/Burr hole

Procedure: Traditional Surgery

Interventions

Middle Meningeal Artery procedurePROCEDURE

Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma

Middle Meningeal Artery Embolization
Traditional SurgeryPROCEDURE

Drainage of Subdural Hematoma using Craniotomy or Burr Hole

Traditional Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Participant or Surrogate must be English speaking
  • Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an
  • One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
  • In opinion of Investigator or the subject's referring physician, the subject has failed conservative management.

You may not qualify if:

  • The Subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment
  • Any requirement for urgent surgical evacuation is necessary
  • Life expectancy is less than 6 months in the opinion of the subject's primary physician
  • Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram
  • Acute subdural hematomas
  • Health insurance doesn't cover MMA embolization or performing Surgeon and follow up visits are considered out of network.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Overlook Medical Center

Summit, New Jersey, 07901, United States

RECRUITING

Related Publications (1)

  • Fuentes AM, Khalid SI, Mehta AI. Predictors of Subsequent Intervention After Middle Meningeal Artery Embolization for Treatment of Subdural Hematoma: A Nationwide Analysis. Neurosurgery. 2023 Jan 1;92(1):144-149. doi: 10.1227/neu.0000000000002151. Epub 2022 Sep 21.

    PMID: 36129273DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematomaHemorrhageWounds and Injuries

Central Study Contacts

Benitez

CONTACT

973-285-7800rbenitez@ansdocs.com

Elena Lobur, RN

CONTACT

908-522-2045elena.lobur@atlantichealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endovascular Surgery

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 19, 2019

Study Start

June 19, 2019

Primary Completion

April 19, 2022

Study Completion

April 19, 2022

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)