An observational study in Subdural Hematoma and Subdural Hematoma, Chronic, sponsored by Aesculap AG. Recruiting at 6 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Aesculap AG (part of B. Braun) · Observational
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 178 is below the median of 210 across 20 observational studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Compared within Hematoma, Subdural, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hematoma, Subdural. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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-5L
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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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