Histoacryl glue embolization of the middle meningeal artery for chronic subdural hematoma (HARMONY)
Observational, Prospective, Multicenter Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
This study tests whether injecting Histoacryl glue into the middle meningeal artery can prevent recurrence or worsening of chronic subdural hematoma in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 178 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 7 sites (Kobe, Chuo-ku and 6 other locations) |
| Trial ID | NCT07258069 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults with chronic or recurrent subdural hematoma who undergo embolization of the middle meningeal artery using Histoacryl (a medical glue). Participants are recruited at three Japanese hospitals and are followed clinically and with imaging for up to six months to record recurrence or progression. Key eligibility excludes patients who need immediate craniotomy, have unsafe vascular anatomy for embolization, significant coagulopathy, or pregnancy. Data will be collected on safety, radiographic outcomes, and any need for additional surgical treatment.
Who should consider this trial
Good fit: Adults (18+) with a confirmed chronic or recurrent subdural hematoma who are candidates for middle meningeal artery embolization and can attend follow-up visits are ideal.
Not a fit: Patients requiring craniotomy, with large space-occupying lesions, unsafe MMA anatomy, significant coagulation problems, or who are pregnant are unlikely to benefit from this embolization approach.
Why it matters
Potential benefit: If successful, the approach could reduce the chance of hematoma recurrence and lower the need for repeat surgery.
How similar studies have performed: Other studies of middle meningeal artery embolization using various embolic agents have shown promising reductions in recurrence, while Histoacryl use has been reported but is less extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kobe, Chuo-ku and 6 other locations
- Kobe City Medical Center General Hospital — Kobe, Chuo-ku, Japan (Not_yet_recruiting)
- Kokura Memorial Hospital — Fukuoka, Kitakyushu-city, Japan (Not_yet_recruiting)
- Ohara HealthCare Foundation Kurashiki Central Hospital — Okayama, Kurashiki, Japan (Not_yet_recruiting)
- Shimizu Hospital — Kyoto, Nishikyo-ku, Japan (Recruiting)
- National Hospital Organization Osaka National Hospital — Osaka-Fu, Osaka-shi, Japan (Not_yet_recruiting)
- Kyoto University Hospital — Kyoto, Sakyo-ku, Japan (Not_yet_recruiting)
- National Cerebral and Cardiovascular Center — Osaka, Suita, Japan (Not_yet_recruiting)
Study contacts
- Study coordinator: Marta Soteras, Dr.
- Email: studies@aesculap.de
- Phone: +34 935 8662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.