Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Subdural Hematoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)
Overview
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.
Primary outcome measures
- Reaccumulation of Hematoma [Time frame: Within 1 month post MMAE]
- Rescue surgical evacuation [Time frame: Between 1-3 months post MMAE]
Secondary outcome measures (12)
- Reaccumulation of Hematoma [Time frame: Between 1-3 months post MMAE]
- Reaccumulation of Hematoma [Time frame: Between 3-6 months post MMAE]
- Reaccumulation of Hematoma [Time frame: Between 6-12 months post MMAE]
- Reaccumulation of Hematoma [Time frame: Between 12-24 months post MMAE]
- Clinical Outcome at Follow-up Clinical outcome at follow-up [Time frame: Upon study discharge, 1-4 weeks]
- Clinical Outcome at Follow-up Clinical outcome at follow-up [Time frame: Within 1 month post MMAE]
- Clinical Outcome at Follow-up Clinical outcome at follow-up [Time frame: Between 1-3 months post MMAE]
- Clinical Outcome at Follow-up Clinical outcome at follow-up [Time frame: Between 3-6 months post MMAE]
- Clinical Outcome at Follow-up Clinical outcome at follow-up [Time frame: Between 6-12 months post MMAE]
- Clinical Outcome at Follow-up Clinical outcome at follow-up [Time frame: Between 12-24 months post MMAE]
- Complications following MMAE [Time frame: Following the procedure, up to 4 weeks]
- Timing of Complications [Time frame: Following the procedure, up to 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 15 centers
- Baptist Health South Florida, Inc. — Coral Gables
- Mayo Clinic Florida — Jacksonville
- Orlando Regional Medical Center — Orlando
- University of Illinois Chicago — Chicago
- University of Chicago Medicine — Chicago
- The University of Iowa — Iowa City
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School — Boston
- … and 7 more centers
Canada · 3 centers
- Unity Health Toronto — Toronto
- University of Toronto — Toronto
- Toronto Western Hospital — Toronto
Australia · 1 center
- Austin Health — Heidelberg
Identifiers
NCT: NCT06181994 · 2023-15327