MMA embolization
RadiationMiddle meningeal artery embolization
NCT Number: NCT06163547
Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Geneva University Hospitals, Geneva, Switzerland
Evidence to support the benefit of MMA embolization remains limited and the risk-benefit balance remains unclear. Case series have shown that recurrence rates with embolization are much lower, and that embolization is generally very safe. Risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure. Risks include access site hematoma, radiation exposure, vascular injury, brain ischemia, death (theoretic and extremely unlikely) and typical risks associated with general or local anaesthesia. The potential efficacy of MMA embolization as a treatment therefore requires higher level evidence in the form of randomized control trials.
The benefit of the embolization is a substantial reduction in recurrence of cSDH, which has been reported to be as high 1 in 3-4 patients. Recurrence of cSDH can lead to additional surgery and complications.
First objective: Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments (Arm 2) versus surgery alone (Arms 1).
Second objective: The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at follow-up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Middle meningeal artery embolization
Time frame: 6-months
Surgical reoperation
Time frame: 6-months
Neurological deterioration due to a cSDH after evacuation
Time frame: 6-months
Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up
Time frame: 6-months
Glasgow Coma Scale (Min=3; Max=15; Higher score=Best outcome)
Time frame: 6-months
modified Ranking Scale (Min=0; Max=6; Higher score=Worse outcome)
Time frame: 6-months
Markwalder Grading Scale (Min=0; Max=4; Higher score=Worse outcome)
Time frame: 6-months
Glasgow Outcome Scale - Extended (Min=1; Max=8; Higher score=Best outcome)
Time frame: 6-months
Karnofsky Performance Score (Min=20; Max=100; Higher score=Best outcome)
Time frame: 6-months
Therapy-Disability-Neurology grading system (Min=1; Max=5; Higher score=Worse outcome)
Time frame: 6-months
Mortality rate
Time frame: 6-months
Re-hospitalisation for all causes
Contact information is provided by the study sponsor or research team.
University Hospital, Geneva
Other
Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial
Acronym: STORMM
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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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