Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)
- Conditions
- Cerebral Compression Due to InjuryChronic Subdural Hematomas
- Interventions
- Radiation: MMA embolization
- Registration Number
- NCT06163547
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- Age: 18-100
- Consent possible
- cSDH located at the convexities
- Patients with symptomatic cSDH
- Patients with asymptomatic large chronic/subacute hematoma after 6 weeks of failed conservative treatment
- Consent not possible
- Pregnancy
- Prisoner
- Angiography contraindication
- Patient for whom follow-up is problematic (e.g. distant residency, homeless ...)
- Previous surgery for cSDH
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 - Surgery - MMA embolisation MMA embolization Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management. Arm 3 - No surgery - Embolization accepted MMA embolization Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization accepted : Arm 3.
- Primary Outcome Measures
Name Time Method Recurrence of cSDH - 1 6-months Surgical reoperation
Recurrence of cSDH - 2 6-months Neurological deterioration due to a cSDH after evacuation
Recurrence of cSDH - 3 6-months Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up
- Secondary Outcome Measures
Name Time Method Additional clinical outcomes - 1 6-months Glasgow Coma Scale (Min=3; Max=15; Higher score=Best outcome)
Additional clinical outcomes - 2 6-months modified Ranking Scale (Min=0; Max=6; Higher score=Worse outcome)
Additional clinical outcomes - 3 6-months Markwalder Grading Scale (Min=0; Max=4; Higher score=Worse outcome)
Additional clinical outcomes - 4 6-months Glasgow Outcome Scale - Extended (Min=1; Max=8; Higher score=Best outcome)
Additional clinical outcomes - 5 6-months Karnofsky Performance Score (Min=20; Max=100; Higher score=Best outcome)
Additional clinical outcomes - 7 6-months Mortality rate
Additional clinical outcomes - 6 6-months Therapy-Disability-Neurology grading system (Min=1; Max=5; Higher score=Worse outcome)
Additional clinical outcomes - 8 6-months Re-hospitalisation for all causes
Trial Locations
- Locations (1)
Geneva University Hospitals
🇨ðŸ‡Geneva, Switzerland