Chronic Subdural Hematoma
Conditions
Keywords
Middle meningeal artery embolization, Endovascular Embolization
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.
Interventions
None listed
Sponsors
Geisinger Clinic
Heidelberg University
Henri Mondor University Hospital
Ospedale Policlinico San Martino
Ospedale San Raffaele
Lehigh Valley Hospital
Mayo Clinic
Medical University of South Carolina
New York University
Oregon Health and Science University
Sisters of Mercy University Hospital
Unity Health Toronto
Sutter Health
University of Iowa
Thomas Jefferson University
University Health Network, Toronto
University Hospital, Bordeaux
University of Alabama at Birmingham
University of South Florida
University of Washington
Cornell University
Westchester Medical Center
Montefiore Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Timing of Complications | Following the procedure, up to 4 weeks | Complications will be categorized and tabulated as having occurred perioperatively or postoperatively |
| 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 |
| Reaccumulation of Hematoma | Between 1-3 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 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 |
| Duration of Hospital Stay | Upon study discharge, up to 24 months | The median duration of hospital stay will be tabulated and reported |
| Clinical Outcome at Follow-up Clinical outcome at follow-up | Upon study discharge, 1-4 weeks | 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. |
Countries
Australia, Canada, United States
Contacts
Primary ContactMuhammed Amir Essibayi, MD
Outcome results
None listed