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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Subdural Hematoma; Subdural Hematoma, Chronic
• Intervention / Treatment: Device: Histoacryl®

• Study Type: Observational
• Enrollment (Estimated): 178

Contacts and Locations

• Study Contact: Name: Marta Soteras, Dr.; Phone Number: 00 +34 935 8662; Email: studies@aesculap.de
• Study Contact Backup: Name: Yumiko Okaniva, Dr.; Phone Number: 2525 +81 3814; Email: gen.jp@bbraun.jp

Study Locations

• Japan
  • Chuo-ku
    • Kobe, Chuo-ku, Japan, 〒650-0047
      • Not yet recruiting
      • Kobe City Medical Center General Hospital
      • Contact: Hirotoshi Imamura, Dr.; Phone Number: 078-302-4321
  • Kitakyushu-city
    • Fukuoka, Kitakyushu-city, Japan, 〒802-8555
      • Not yet recruiting
      • Kokura Memorial Hospital
      • Contact: Taketo Hatano, Dr.; Phone Number: 093-511-2000
  • Kurashiki
    • Okayama, Kurashiki, Japan, 〒710-8602
      • Not yet recruiting
      • Ohara HealthCare Foundation Kurashiki Central Hospital
      • Contact: Masanori Kinosada, Dr.; Phone Number: 086-422-0210
  • Nishikyo-ku
    • Kyoto, Nishikyo-ku, Japan, 〒615-8237
      • Recruiting
      • Shimizu Hospital
      • Contact: Nobuyuki Sakai, Dr.; Phone Number: 075-381-5161
  • Osaka-shi
    • Osaka-Fu, Osaka-shi, Japan, 〒540-0006
      • Not yet recruiting
      • National Hospital Organization Osaka National Hospital
      • Contact: Toshiyuki Fujinaka, Dr.; Phone Number: 06-6942-1331
  • Sakyo-ku
    • Kyoto, Sakyo-ku, Japan, 〒606-8507
      • Not yet recruiting
      • Kyoto University Hospital
      • Contact: Chiaki Sakai, Dr.; Phone Number: 311 0570-030
  • Suita
    • Osaka, Suita, Japan, 〒564-8565
      • Not yet recruiting
      • National Cerebral and Cardiovascular Center
      • Contact: Masakazu Okawa, Dr.; Phone Number: 0570-012-545

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy (1. Time)	Time period from symptoms to embolization	V1, preoperatively (baseline visit)
Efficacy (2. Time)	Time period from burr-hole drainage to embolization	V2, surgery (index procedure)
Efficacy (3. Time)	Time period from embolization to recurrence	6 months
Efficacy (4. Hematoma thickness)	Change in hematoma thickness	at V4: 3 months and V5: 6 months compared to baseline
Efficacy (5. Change in midlind shift)	Change in midline shift compared to baseline	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)	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)	V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: AAG-O-H-25118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No