Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital, Geneva

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-100

Consent possible

cSDH located at the convexities

Patients with symptomatic cSDH

Disqualifiers

Consent not possible

Pregnancy

Prisoner

Angiography contraindication

Trial design

Design model

Parallel

Treatments tested in this trial

  • MMA embolization

    Radiation

    Middle meningeal artery embolization

Treatment groups

180 Participants
are divided into 4 treatment groups
Group A: Arm 1 - Surgery - No embolization (control)No intervention 0 interventions
Group B: Arm 2 - Surgery - MMA embolisationExperimental treatment 1 intervention
Group C: Arm 3 - No surgery - Embolization acceptedActive comparator 1 intervention
Group D: Arm 4 - No surgery - Embolization not acceptedNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recurrence of cSDH - 1

Surgical reoperation

Time frame
6-months
2

Recurrence of cSDH - 2

Neurological deterioration due to a cSDH after evacuation

Time frame
6-months
3

Recurrence of cSDH - 3

Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up

Time frame
6-months

Secondary outcomes

1

Additional clinical outcomes - 1

Glasgow Coma Scale (Min=3; Max=15; Higher score=Best outcome)

Time frame
6-months
2

Additional clinical outcomes - 2

modified Ranking Scale (Min=0; Max=6; Higher score=Worse outcome)

Time frame
6-months
3

Additional clinical outcomes - 3

Markwalder Grading Scale (Min=0; Max=4; Higher score=Worse outcome)

Time frame
6-months
4

Additional clinical outcomes - 4

Glasgow Outcome Scale - Extended (Min=1; Max=8; Higher score=Best outcome)

Time frame
6-months

Other outcomes

Sponsors and contacts

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