Actively Recruiting
Led by University Hospital, Geneva · Updated on 2026-03-17
180
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are investigating the use of middle meningeal artery (MMA) embolization as a treatment for chronic subdural hematomas (cSDH), which often cause neurological problems due to pressure on the brain. This study aims to evaluate whether adding MMA embolization after surgery can reduce the chance of hematoma returning and improve patient outcomes. It also explores if MMA embolization alone can be effective for patients who cannot or choose not to have surgery. The trial includes four groups: patients receiving surgery followed by MMA embolization within 72 hours, patients receiving surgery without embolization, patients who cannot have surgery but accept embolization, and patients who cannot have surgery and refuse embolization. Participants will be randomly assigned to these groups, with a 2:1 ratio favoring embolization after surgery in the surgical arms. Participants will be monitored over six months to assess the recurrence of cSDH and other clinical outcomes. The study involves standard clinical assessments, imaging, and follow-up visits to evaluate the stability and reduction of hematomas. Safety risks related to embolization and surgical procedures will be explained to patients or caregivers as part of the consent process.
CONDITIONS
Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery and initial recovery period
Participants who require surgical treatment undergo surgery as part of their care.
1 surgical procedure
Duration - Up to 72 hours post-surgery for embolization or as per treatment plan for embolization-only participants
Participants receive either middle meningeal artery embolization within 72 hours after surgery, embolization alone if not undergoing surgery, or no embolization depending on their assigned arm.
1 embolization procedure or no embolization depending on treatment arm
Duration - 6 months
Participants are monitored for recurrence and stability of chronic subdural hematomas after treatment.
Regular follow-up visits over 6 months
Total: 2 locations
1
Geneva University Hospitals
Geneva, Switzerland
Actively Recruiting
2
EOC
Lugano, Switzerland
Actively Recruiting
A
Aria Nouri
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Abdullah Al Awadhi, Caterina Mollica, Michele Da Broi...
https://pubmed.ncbi.nlm.nih.gov/40335147