The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.
Study Type
OBSERVATIONAL
Enrollment
178
Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.
Recurrence or progression of subdural hematoma
Recurrence will be described as maximum thickness of SDH exceeding 10 mm, recurrence of symptoms or the patient requiring reoperation, meaning a second burr-hole drainage due to SDH. \*\*Progression will be described as maximum thickness of SDH increasing over 3 mm compared to the baseline.
Time frame: within 3 months
Efficacy (1. Time)
Time period from symptoms to embolization
Time frame: V1, preoperatively (baseline visit)
Efficacy (2. Time)
Time period from burr-hole drainage to embolization
Time frame: V2, surgery (index procedure)
Efficacy (3. Time)
Time period from embolization to recurrence
Time frame: 6 months
Efficacy (4. Hematoma thickness)
Change in hematoma thickness
Time frame: at V4: 3 months and V5: 6 months compared to baseline
Efficacy (5. Change in midlind shift)
Change in midline shift compared to baseline
Time frame: at V4: 3 months and V5: 6 months
Efficacy (6. Cognitive assessment)
Mini-Mental State Examination (MMSE) from 0 (severe cognitive impairment) to 30 (no cognitive impairment)
Time frame: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months
Quality of life, EQ-5D
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assessed by EQ-5D scale from 0 (worst health) to 100 (best health)
Time frame: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months