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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06181994
Other study ID # 2023-15327
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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