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 volunteersQualifiers
Age: 18-100
Consent possible
cSDH located at the convexities
Patients with symptomatic cSDH
Disqualifiers
Consent not possible
Pregnancy
Prisoner
Angiography contraindication
Trial design
Parallel
Treatments tested in this trial
MMA embolization
RadiationMiddle meningeal artery embolization
Treatment groups
Trial outcomes
Primary outcomes
Recurrence of cSDH - 1
Surgical reoperation
Recurrence of cSDH - 2
Neurological deterioration due to a cSDH after evacuation
Recurrence of cSDH - 3
Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up
Secondary outcomes
Additional clinical outcomes - 1
Glasgow Coma Scale (Min=3; Max=15; Higher score=Best outcome)
Additional clinical outcomes - 2
modified Ranking Scale (Min=0; Max=6; Higher score=Worse outcome)
Additional clinical outcomes - 3
Markwalder Grading Scale (Min=0; Max=4; Higher score=Worse outcome)
Additional clinical outcomes - 4
Glasgow Outcome Scale - Extended (Min=1; Max=8; Higher score=Best outcome)
Sponsors and contacts
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