Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMontefiore Medical Center

About this trial

This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consecutive adult patients (18 yrs. of age or older)

Disqualifiers

Endovascular embolization of middle meningeal artery using any other embolization material

Trial population

Patients with chronic subdural hematoma

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 3 trial groups
Group A: MMA Embolization
Group B: Surgical Evacuation
Group C: Observation only

Trial outcomes

Primary outcomes

1

Reaccumulation of Hematoma

The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported

Time frame
Within 1 month post MMAE
2

Rescue surgical evacuation

The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported

Time frame
Between 1-3 months post MMAE

Secondary outcomes

1

Reaccumulation of Hematoma

The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point.

Time frame
Between 1-3 months post MMAE
2

Reaccumulation of Hematoma

The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point.

Time frame
Between 3-6 months post MMAE
3

Reaccumulation of Hematoma

The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point.

Time frame
Between 6-12 months post MMAE
4

Reaccumulation of Hematoma

The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point.

Time frame
Between 12-24 months post MMAE

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montefiore Medical Center

Lead sponsor

Geisinger Clinic

Collaborator

Heidelberg University

Collaborator

Henri Mondor University Hospital

Collaborator

Ospedale Policlinico San Martino

Collaborator

Ospedale San Raffaele

Collaborator

Lehigh Valley Hospital

Collaborator

Mayo Clinic

Collaborator

Medical University of South Carolina

Collaborator

New York University

Collaborator

Oregon Health and Science University

Collaborator

Sisters of Mercy University Hospital

Collaborator

Unity Health Toronto

Collaborator

Sutter Health

Collaborator

University of Iowa

Collaborator

Thomas Jefferson University

Collaborator

University Health Network, Toronto

Collaborator

University Hospital, Bordeaux

Collaborator

University of Alabama at Birmingham

Collaborator

University of South Florida

Collaborator

University of Washington

Collaborator

Cornell University

Collaborator

Westchester Medical Center

Collaborator