Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

Condition(s) studied

Investigational drug(s) / intervention(s)

MMA embolization: Middle meningeal artery embolization

Study 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

Primary outcome measure(s)

• 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

Trial sites (2)

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