OBSERVATIONAL, PROSPECTIVE, MULTICENTER STUDY ON HISTOACRYL USED FOR EMBOLIZATION OF MIDDLE MENINGEAL ARTERY (MMA) IN CHRONIC SUBDURAL HEMATOMA (CSDH)

OBSERVATIONAL, PROSPECTIVE, MULTICENTER STUDY ON HISTOACRYL USED FOR EMBOLIZATION OF MIDDLE MENINGEAL ARTERY (MMA) IN CHRONIC SUBDURAL HEMATOMA (CSDH) - HARMONY study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1052250165

Enrollment

178

Registered

2025-12-08

Start date

2026-02-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Subdural Hematoma Chronic Subdural Hematoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -18 years old or older - Confirmed diagnosis of chronic subdural hematoma or recurrent subdural hematoma - Completed documented informed consent - Willingness and presumed capability to participate in follow-up visits for up to 6 months

Exclusion criteria

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 - Coagulation dysfunction with INR>1.8 and/or platelet count <80*109/L - Allergic reactions to Histoacryl and 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
Recurrence or progression of subdural hematoma within 3 months following the index procedure	—

Secondary

Measure	Time frame
Efficacy -Time period from symptoms to embolization, from burr-hole drainage to embolization and from embolization to recurrence -Change in hematoma thickness at V4: 3 months and V5: 6 months compared to baseline -Change in midline shift at V4: 3 months and V5: 6 months compared to baseline -Cognitive assessment assessed by MMSE at V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months -Quality of life assessed by EQ-5D scale from 0 (worst health) to 100 (best health) at V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months Safety -Rate of (Serious) Adverse Events at V3: discharge, V4: 3 months and V5: 6 months -Duration of Hospital stay after index procedure -Rate and duration of rehospitalization Handling of Histoacryl -Volume -Targeted arteries (main trunk of MMA / frontal branches / parietal branches) -Injection time -Intraoperative complications/AEs (catheter breakage or entrapment, etc)	—

Measure

Time frame

Efficacy -Time period from symptoms to embolization, from burr-hole drainage to embolization and from embolization to recurrence -Change in hematoma thickness at V4: 3 months and V5: 6 months compared to baseline -Change in midline shift at V4: 3 months and V5: 6 months compared to baseline -Cognitive assessment assessed by MMSE at V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months -Quality of life assessed by EQ-5D scale from 0 (worst health) to 100 (best health) at V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months Safety -Rate of (Serious) Adverse Events at V3: discharge, V4: 3 months and V5: 6 months -Duration of Hospital stay after index procedure -Rate and duration of rehospitalization Handling of Histoacryl -Volume -Targeted arteries (main trunk of MMA / frontal branches / parietal branches) -Injection time -Intraoperative complications/AEs (catheter breakage or entrapment, etc)

—

Contacts

Public ContactSakai Chiaki

Kyoto University Hospital

chiakisa@kuhp.kyoto-u.ac.jp+81-75-751-3459

Outcome results