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.
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 Type
OBSERVATIONAL
Enrollment
5,000
Baptist Health South Florida, Inc.
Coral Gables, Florida, United States
RECRUITINGReaccumulation 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
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
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
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
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
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.
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Mayo Clinic Florida
Jacksonville, Florida, United States
COMPLETEDOrlando Regional Medical Center
Orlando, Florida, United States
RECRUITINGUniversity of Illinois Chicago
Chicago, Illinois, United States
COMPLETEDUniversity of Chicago Medicine
Chicago, Illinois, United States
RECRUITINGThe University of Iowa
Iowa City, Iowa, United States
COMPLETEDMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBeth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School
Boston, Massachusetts, United States
RECRUITINGLahey Hospital and Medical Center
Burlington, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
COMPLETED...and 9 more locations
Time frame: Between 12-24 months post MMAE
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.
Time frame: Upon study discharge, 1-4 weeks
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.
Time frame: Within 1 month post MMAE
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.
Time frame: Between 1-3 months post MMAE
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.
Time frame: Between 3-6 months post MMAE
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.
Time frame: Between 6-12 months post MMAE
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.
Time frame: Between 12-24 months post MMAE
Complications following MMAE
Complications following MMAE will be identified and tabulated as either permanent or transient in nature
Time frame: Following the procedure, up to 4 weeks
Timing of Complications
Complications will be categorized and tabulated as having occurred perioperatively or postoperatively
Time frame: Following the procedure, up to 4 weeks
Relatedness of Complications
Complications will be assessed as to whether or not they were related to the surgical procedure
Time frame: Following the procedure, up to 4 weeks
Duration of Hospital Stay
The median duration of hospital stay will be tabulated and reported
Time frame: Upon study discharge, up to 24 months
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.
Time frame: Upon study discharge, up to 24 months
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
Time frame: Upon study discharge, up to 24 months
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 3-12 months post MMAE