NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Chronic Subdural Hematoma
Date of first enrollment	16/02/2026
Target sample size	178
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

Recurrence or progression of subdural hematoma within 3 months following the index procedure

Secondary Outcome

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)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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