Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Geneva University Hospitals
RECRUITING
Geneva
Contact Information
Primary
Aria Nouri
aria.nouri@hug.ch
+41795530958
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 180
Treatments
No_intervention: Arm 1 - Surgery - No embolization (control)
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.
Experimental: Arm 2 - Surgery - MMA embolisation
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.
Active_comparator: Arm 3 - No surgery - Embolization accepted
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.
No_intervention: Arm 4 - No surgery - Embolization not accepted
Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization refused : Arm 4.
Sponsors
Leads: University Hospital, Geneva

This content was sourced from clinicaltrials.gov