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

Chronic Subdural Hematoma Clinical Trial

— MESH  

Official title:

Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181994
• Other study ID #: 2023-15327
• Status: Recruiting
• Start date: December 5, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Montefiore Medical Center
• Contact: Muhammed Amir Essibayi, MD
• Phone: 347-908-1889
• Email: muhammedamir.essibayi[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaccumulation of Hematoma	The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported	Within 1 month post MMAE
Primary	Rescue surgical evacuation	The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported	Between 1-3 months post MMAE
Secondary	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.	Between 1-3 months post MMAE
Secondary	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.	Between 3-6 months post MMAE
Secondary	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.	Between 6-12 months post MMAE
Secondary	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.	Between 12-24 months post MMAE
Secondary	Clinical Outcome at Follow-up Clinical outcome at follow-up	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.	Upon study discharge, 1-4 weeks
Secondary	Clinical Outcome at Follow-up Clinical outcome at follow-up	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.	Within 1 month post MMAE
Secondary	Clinical Outcome at Follow-up Clinical outcome at follow-up	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.	Between 1-3 months post MMAE
Secondary	Clinical Outcome at Follow-up Clinical outcome at follow-up	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.	Between 3-6 months post MMAE
Secondary	Clinical Outcome at Follow-up Clinical outcome at follow-up	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.	Between 6-12 months post MMAE
Secondary	Clinical Outcome at Follow-up Clinical outcome at follow-up	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.	Between 12-24 months post MMAE
Secondary	Complications following MMAE	Complications following MMAE will be identified and tabulated as either permanent or transient in nature	Following the procedure, up to 4 weeks
Secondary	Timing of Complications	Complications will be categorized and tabulated as having occurred perioperatively or postoperatively	Following the procedure, up to 4 weeks
Secondary	Relatedness of Complications	Complications will be assessed as to whether or not they were related to the surgical procedure	Following the procedure, up to 4 weeks
Secondary	Duration of Hospital Stay	The median duration of hospital stay will be tabulated and reported	Upon study discharge, up to 24 months
Secondary	Clinical outcome at discharge	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.	Upon study discharge, up to 24 months
Secondary	Disposition After Discharge	Disposition upon discharge will be categorized as either discharged to home; discharged to home with health service, discharged to rehabilitation facility, or death	Upon study discharge, up to 24 months
Secondary	Rescue surgical evacuation	The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported	Between 3-12 months post MMAE