Subdural Hematoma, Subdural Hematoma, Chronic
Conditions
Brief summary
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.
Interventions
DEVICEHistoacryl®
Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * Confirmed diagnosis of chronic subdural hematoma (CSDH) or recurrent subdural hematoma (SDH) * Completed documented informed consent * Willingness and presumed capability to participate in follow-up visits for up to 6 months (180±30 days)
Exclusion criteria
* Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment * Need craniotomy * Any sign of anatomical variations that could make MMA embolization unsafe (e.g., prominent MMA-opthalmic artery anastomoses) * Coagulation dysfunction with INR\>1.8 and/or platelet count \<80x109 /L * Allergic reactions to essential medicines to do angiography * Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study * Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence or progression of subdural hematoma | within 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (1. Time) | V1, preoperatively (baseline visit) | Time period from symptoms to embolization |
| Efficacy (2. Time) | V2, surgery (index procedure) | Time period from burr-hole drainage to embolization |
| Efficacy (3. Time) | 6 months | Time period from embolization to recurrence |
| Efficacy (4. Hematoma thickness) | at V4: 3 months and V5: 6 months compared to baseline | Change in hematoma thickness |
| Efficacy (5. Change in midlind shift) | at V4: 3 months and V5: 6 months | Change in midline shift compared to baseline |
| Efficacy (6. Cognitive assessment) | V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months | Mini-Mental State Examination (MMSE) from 0 (severe cognitive impairment) to 30 (no cognitive impairment) |
| Quality of life, EQ-5D-5L | V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months | assessed by EQ-5D scale from 0 (worst health) to 100 (best health) |
Countries
Japan
Contacts
CONTACTMarta Soteras, Dr.
CONTACTYumiko Okaniva, Dr.
Outcome results
None listed