Clinical trial NCT06181994: Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)
Official title: Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Subdural Hematoma
Keywords: Middle meningeal artery embolization
Endovascular Embolization
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Geisinger Clinic
name: Heidelberg University
name: Henri Mondor University Hospital
name: Ospedale Policlinico San Martino
name: Ospedale San Raffaele
name: Lehigh Valley Hospital
name: Mayo Clinic
name: Medical University of South Carolina
name: New York University
name: Oregon Health and Science University
name: Sisters of Mercy University Hospital
name: Unity Health Toronto
name: Sutter Health
name: University of Iowa
name: Thomas Jefferson University
name: University Health Network, Toronto
name: University Hospital, Bordeaux
name: University of Alabama at Birmingham
name: University of South Florida
name: University of Washington
name: Cornell University
name: Westchester Medical Center
First posted: 2023-12-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic subdural hematoma

Brief summary: 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.

Detailed description: Chronic subdural hematoma (cSDH) is a prevalent neurosurgical condition marked by the accumulation of blood in the subarachnoid space. Primarily affecting elderly individuals, cSDH is associated with significant morbidity and mortality rates. Current standard treatments for cSDH involve surgical evacuation through burr hole craniotomy or twist-drill craniotomy; however, recent research has illuminated the potential significance of the middle meningeal artery (MMA) in cSDH pathogenesis, suggesting an innovative minimally invasive treatment avenue. The investigator team is attempting to determine whether MMA embolization has demonstrated a favorable safety profile with a low incidence of treatment-related complications.

Eligibility criteria: Inclusion Criteria:

* Consecutive adult patients (18 yrs. of age or older)
* Endovascular embolization of middle meningeal artery using any embolization material:

PVA particles; Onyx, nBCA glue; dimethyl sulfoxide, microcoils, PVA with microcoils

Exclusion Criteria:

* Endovascular embolization of middle meningeal artery using any other embolization material

Primary outcomes:
measure: Reaccumulation of Hematoma
timeFrame: Within 1 month post MMAE
measure: Rescue surgical evacuation
timeFrame: Between 1-3 months post MMAE
Secondary outcomes:
measure: Reaccumulation of Hematoma
timeFrame: Between 1-3 months post MMAE
measure: Reaccumulation of Hematoma
timeFrame: Between 3-6 months post MMAE
measure: Reaccumulation of Hematoma
timeFrame: Between 6-12 months post MMAE
measure: Reaccumulation of Hematoma
timeFrame: Between 12-24 months post MMAE
measure: Clinical Outcome at Follow-up Clinical outcome at follow-up
timeFrame: Upon study discharge, 1-4 weeks
measure: Clinical Outcome at Follow-up Clinical outcome at follow-up
timeFrame: Within 1 month post MMAE
measure: Clinical Outcome at Follow-up Clinical outcome at follow-up
timeFrame: Between 1-3 months post MMAE
measure: Clinical Outcome at Follow-up Clinical outcome at follow-up
timeFrame: Between 3-6 months post MMAE
measure: Clinical Outcome at Follow-up Clinical outcome at follow-up
timeFrame: Between 6-12 months post MMAE
measure: Clinical Outcome at Follow-up Clinical outcome at follow-up
timeFrame: Between 12-24 months post MMAE
measure: Complications following MMAE
timeFrame: Following the procedure, up to 4 weeks
measure: Timing of Complications
timeFrame: Following the procedure, up to 4 weeks
measure: Relatedness of Complications
timeFrame: Following the procedure, up to 4 weeks
measure: Duration of Hospital Stay
timeFrame: Upon study discharge, up to 24 months
measure: Clinical outcome at discharge
timeFrame: Upon study discharge, up to 24 months
measure: Disposition After Discharge
timeFrame: Upon study discharge, up to 24 months
measure: Rescue surgical evacuation
timeFrame: Between 3-12 months post MMAE
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: David Altschul, MD
role: PRINCIPAL_INVESTIGATOR
References: