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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Histoacryl® | Device | Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (1. Time) | Time period from symptoms to embolization | V1, preoperatively (baseline visit) |
| Efficacy (2. Time) | Time period from burr-hole drainage to embolization |
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Inclusion Criteria:
Exclusion Criteria:
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A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Soteras, Dr. | Contact | +34 935 8662 | 00 | studies@aesculap.de |
| Yumiko Okaniva, Dr. | Contact | +81 3814 | 2525 | gen.jp@bbraun.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe City Medical Center General Hospital | Not yet recruiting | Kobe | Chuo-ku | 〒650-0047 | Japan |
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| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| V2, surgery (index procedure) |
| Efficacy (3. Time) | Time period from embolization to recurrence | 6 months |
| Efficacy (4. Hematoma thickness) | Change in hematoma thickness | at V4: 3 months and V5: 6 months compared to baseline |
| Efficacy (5. Change in midlind shift) | Change in midline shift compared to baseline | 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) | V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months |
| Quality of life, EQ-5D-5L | assessed by EQ-5D scale from 0 (worst health) to 100 (best health) | V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months |
| Kokura Memorial Hospital | Not yet recruiting | Fukuoka | Kitakyushu-city | 〒802-8555 | Japan |
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| Ohara HealthCare Foundation Kurashiki Central Hospital | Not yet recruiting | Okayama | Kurashiki | 〒710-8602 | Japan |
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| Shimizu Hospital | Recruiting | Kyoto | Nishikyo-ku | 〒615-8237 | Japan |
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| National Hospital Organization Osaka National Hospital | Not yet recruiting | Osaka-Fu | Osaka-shi | 〒540-0006 | Japan |
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| Kyoto University Hospital | Not yet recruiting | Kyoto | Sakyo-ku | 〒606-8507 | Japan |
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| National Cerebral and Cardiovascular Center | Not yet recruiting | Osaka | Suita | 〒564-8565 | Japan |
|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |