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Recruiting NCT07258069

Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)

— Observational Subdural Hematoma Subdural Hematoma, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Histoacryl®.
Who it may be relevant to
Registry conditions: Subdural Hematoma, Subdural Hematoma, Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observational, Prospective, Multicenter Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)

Overview

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

  • Device Histoacryl®
    Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.

Primary outcome measures

  • Recurrence or progression of subdural hematoma [Time frame: within 3 months]
Secondary outcome measures (7)
  • Efficacy (1. Time) [Time frame: V1, preoperatively (baseline visit)]
  • Efficacy (2. Time) [Time frame: V2, surgery (index procedure)]
  • Efficacy (3. Time) [Time frame: 6 months]
  • Efficacy (4. Hematoma thickness) [Time frame: at V4: 3 months and V5: 6 months compared to baseline]
  • Efficacy (5. Change in midlind shift) [Time frame: at V4: 3 months and V5: 6 months]
  • Efficacy (6. Cognitive assessment) [Time frame: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months]
  • Quality of life, EQ-5D-5L [Time frame: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 7 centers
  • Kobe City Medical Center General Hospital — Kobe
  • Kokura Memorial Hospital — Fukuoka
  • Ohara HealthCare Foundation Kurashiki Central Hospital — Okayama
  • Shimizu Hospital — Kyoto
  • National Hospital Organization Osaka National Hospital — Osaka-Fu
  • Kyoto University Hospital — Kyoto
  • National Cerebral and Cardiovascular Center — Osaka

Identifiers

NCT: NCT07258069 · AAG-O-H-25118

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗