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Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients with Refractory Chronic Subdural Hematoma

Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients with Refractory Chronic Subdural Hematoma - COMPLEMENT study: ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055317
Enrollment
600
Registered
2024-12-01
Start date
2024-12-23
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

Interventions

Conventional treatment with middle meningeal artery embolization Conventional treatment alone

Sponsors

Hyogo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age >=18 2) pre-mRS 0-3 3) Hematoma thickness >=10mm 4) Having at least one risk factor Risk factor: Age >=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score >3, Preoperative volume >=130ml, Preoperative midline shift >=8mm, CT appearance (Homogeneous, laminar or separated)

Exclusion criteria

Exclusion criteria: 1) Cr >=1.8 2) Plt <50,000, PT-INR >2 3) Life expectancy <6 months

Design outcomes

Primary

MeasureTime frame
Recurrence of chronic subdural hematoma within 6 months after randomization

Countries

Japan

Contacts

Public ContactKazutaka Uchida

Hyogo Medical University Department of Neurosurgery

kuchida@hyo-med.ac.jp0798-45-6455

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026