An observational study in Chronic Subdural Hematoma, sponsored by Montefiore Medical Center. Recruiting at 22 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Montefiore Medical Center · Observational
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.
While traditional surgical interventions have demonstrated positive outcomes in cSDH management, inherent challenges such as perioperative complications, extended hospital stays, and the risk of recurrence persist. Given the emerging insights into cSDH's underlying mechanisms, targeting the MMA presents an intriguing therapeutic alternative. The MMA, which supplies the dura mater's outer layer, has been implicated in cSDH formation and progression due to its fragility and propensity to rupture. By embolization of the MMA (MMAE), the opportunity arises to potentially mitigate bleeding risk and reduce the likelihood of hematoma reaccumulation. Recent case reports and a significant number of retrospective studies have shown encouraging results with MMA embolization as an adjunct or alternative to conventional surgical methods. Nevertheless, most of the reported studies are case series with limited sample sizes. Moreover, a comprehensive assessment of outcomes, complications, and long-term efficacy necessitates well-structured retrospective studies. The findings of this study hold the potential to better understand the outcomes of MMAE for cSDH. This study aims to provide valuable insights that can guide clinical decision-making, potentially leading to improved patient outcomes and more efficient resource utilization,
The following collaborators are also involved in the research:
Hamza Adel Salim Email: HASalim@MDAnderson.org
Adam A Dmytriw MD MPH MSc Email: adam.dmytriw@gmail.com
Rahim Abo Kasem, MD Email: rahim.abokasem@louisville.edu
Name: Muhammed Amir Essibayi, MD Email: m.amir.essibayi@gmail.com
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 210 across 20 observational studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with chronic subdural hematoma
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PVA particles; Onyx, N-butyl cyanoacrylate (nBCA) glue; dimethyl sulfoxide, microcoils, polyvinyl alcohol (PVA) with microcoils
Exclusion Criteria:
Adults with chronic subdural hematoma who underwent endovascular embolization of the middle meningeal artery as part of routine clinical care, using any embolic material
Adults with chronic subdural hematoma who underwent surgical drainage of the hematoma as part of routine clinical care.
Adults with chronic subdural hematoma who were managed with clinical and imaging monitoring, without embolization or surgery.
Reaccumulation 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.
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
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Plan to share: No
Started Dec 2023 (actual). Primary completion is estimated for Dec 2026, 36 months after the start.
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