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Recruiting NCT06163547

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

No phase Interventional Chronic Subdural Hematomas Cerebral Compression Due to Injury

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
The protocol lists: MMA embolization.
Who it may be relevant to
Registry conditions: Chronic Subdural Hematomas, Cerebral Compression Due to Injury. Basic parameters: 18 years — 100 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
Switzerland
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

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

Overview

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.

Interventions

  • Radiation MMA embolization
    Middle meningeal artery embolization

Primary outcome measures

  • Recurrence of cSDH - 1 [Time frame: 6-months]
  • Recurrence of cSDH - 2 [Time frame: 6-months]
  • Recurrence of cSDH - 3 [Time frame: 6-months]
Secondary outcome measures (8)
  • Additional clinical outcomes - 1 [Time frame: 6-months]
  • Additional clinical outcomes - 2 [Time frame: 6-months]
  • Additional clinical outcomes - 3 [Time frame: 6-months]
  • Additional clinical outcomes - 4 [Time frame: 6-months]
  • Additional clinical outcomes - 5 [Time frame: 6-months]
  • Additional clinical outcomes - 6 [Time frame: 6-months]
  • Additional clinical outcomes - 7 [Time frame: 6-months]
  • Additional clinical outcomes - 8 [Time frame: 6-months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Consent not possible
  • Pregnancy
  • Prisoner
  • Angiography contraindication
  • Patient for whom follow-up is problematic (e.g. distant residency, homeless …)
  • Previous surgery for cSDH

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 2 centers
  • Geneva University Hospitals — Geneva
  • EOC — Lugano

Publications

  • Al Awadhi A, Mollica C, Da Broi M, Molliqaj G, Hofmeister J, Rosi A, Bernava G, Machi P, Morel S, Cardia A, Meling TR, Schaller K, Nouri A. Middle meningeal artery (MMA) embolisation for chronic subdural haematomas: rationale and design for the STOp Recurrence of MMA Bleeding (STORMM) randomised control trial-a study protocol. BMJ Open. 2025 May 6;15(5):e092014. doi: 10.1136/bmjopen-2024-092014. PMID 40335147

Identifiers

NCT: NCT06163547 · 2023-00848

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗