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

Recruiting

• Conditions: Chronic Subdural Hematoma

• Registration Number: NCT06181994
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study Start: 2023-12-05
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rescue surgical evacuation	Between 1-3 months post MMAE	The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported
Reaccumulation of Hematoma	Within 1 month post MMAE	The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported

Secondary Outcome Measures

Name	Time	Method
Reaccumulation of Hematoma	Between 12-24 months post MMAE	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.
Clinical Outcome at Follow-up Clinical outcome at follow-up	Between 12-24 months post MMAE	Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Timing of Complications	Following the procedure, up to 4 weeks	Complications will be categorized and tabulated as having occurred perioperatively or postoperatively
Clinical outcome at discharge	Upon study discharge, up to 24 months	Clinical outcome at discharge will be assessed using the modified Rankin Scale (mRS) for neurologic disability. The mRS being used is a 7-point scale with possible scores ranging from 0-6. mRS measures the degree of disability or dependence in the daily activities of people who have suffered neurological disability. Scoring ranges from 0 (no residual symptoms) to 5 (severe neurologic disability). A patient who has expired (during or after discharge from hospital) is assigned a score of 6. Scores will be averaged and reported. Higher mRS scores are associated with progressively less favorable outcomes.
Disposition After Discharge	Upon study discharge, up to 24 months	Disposition upon discharge will be categorized as either discharged to home; discharged to home with health service, discharged to rehabilitation facility, or death
Rescue surgical evacuation	Between 3-12 months post MMAE	The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported
Complications following MMAE	Following the procedure, up to 4 weeks	Complications following MMAE will be identified and tabulated as either permanent or transient in nature
Relatedness of Complications	Following the procedure, up to 4 weeks	Complications will be assessed as to whether or not they were related to the surgical procedure
Duration of Hospital Stay	Upon study discharge, up to 24 months	The median duration of hospital stay will be tabulated and reported

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States