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NCT Number: NCT06181994

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

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.

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Key information

Conditions

Chronic Subdural Hematoma Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Austin Health, Heidelberg, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Reaccumulation of Hematoma

    Time frame: Within 1 month post MMAE

    The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported

  2. Rescue surgical evacuation

    Time frame: 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 outcomes

  1. Reaccumulation of Hematoma

    Time frame: 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.

  2. Reaccumulation of Hematoma

    Time frame: Between 3-6 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.

  3. Reaccumulation of Hematoma

    Time frame: Between 6-12 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.

  4. Reaccumulation of Hematoma

    Time frame: Between 12-24 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.

  5. Clinical Outcome at Follow-up Clinical outcome at follow-up

    Time frame: 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.

  6. Clinical Outcome at Follow-up Clinical outcome at follow-up

    Time frame: Within 1 month post MMAE

    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.

  7. Clinical Outcome at Follow-up Clinical outcome at follow-up

    Time frame: Between 1-3 months post MMAE

    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.

  8. Clinical Outcome at Follow-up Clinical outcome at follow-up

    Time frame: Between 3-6 months post MMAE

    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.

  9. Clinical Outcome at Follow-up Clinical outcome at follow-up

    Time frame: Between 6-12 months post MMAE

    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.

  10. Clinical Outcome at Follow-up Clinical outcome at follow-up

    Time frame: Between 12-24 months post MMAE

    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.

  11. Complications following MMAE

    Time frame: Following the procedure, up to 4 weeks

    Complications following MMAE will be identified and tabulated as either permanent or transient in nature

  12. Timing of Complications

    Time frame: Following the procedure, up to 4 weeks

    Complications will be categorized and tabulated as having occurred perioperatively or postoperatively

  13. Relatedness of Complications

    Time frame: Following the procedure, up to 4 weeks

    Complications will be assessed as to whether or not they were related to the surgical procedure

  14. Duration of Hospital Stay

    Time frame: Upon study discharge, up to 24 months

    The median duration of hospital stay will be tabulated and reported

  15. Clinical outcome at discharge

    Time frame: 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.

  16. Disposition After Discharge

    Time frame: 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

  17. Rescue surgical evacuation

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammed Amir Essibayi, MD

CONTACT

[email protected]

347-908-1889

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Cornell University
  • Geisinger Clinic
  • Heidelberg University
  • Henri Mondor University Hospital
  • Lehigh Valley Hospital
  • Mayo Clinic
  • Medical University of South Carolina
  • New York University
  • Oregon Health and Science University
  • Ospedale Policlinico San Martino
  • Ospedale San Raffaele
  • Sisters of Mercy University Hospital
  • Sutter Health
  • Thomas Jefferson University
  • Unity Health Toronto
  • University Health Network, Toronto
  • University Hospital, Bordeaux
  • University of Alabama at Birmingham
  • University of Iowa
  • University of South Florida
  • University of Washington
  • Westchester Medical Center

Registry information

Official study title

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

Acronym: MESH

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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