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.
Kobe City Medical Center General Hospital
Kobe, Chuo-ku, Japan
NOT_YET_RECRUITINGKokura Memorial Hospital
Fukuoka, Kitakyushu-city, Japan
NOT_YET_RECRUITINGOhara HealthCare Foundation Kurashiki Central Hospital
Okayama, Kurashiki, Japan
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-5L
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Shimizu Hospital
Kyoto, Nishikyo-ku, Japan
RECRUITINGNational Hospital Organization Osaka National Hospital
Osaka-Fu, Osaka-shi, Japan
NOT_YET_RECRUITINGKyoto University Hospital
Kyoto, Sakyo-ku, Japan
NOT_YET_RECRUITINGNational Cerebral and Cardiovascular Center
Osaka, Suita, Japan
NOT_YET_RECRUITINGassessed 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