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Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

RecruitingNAAges 18 Years - anyAllKazutaka Uchida
NCT06772740 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.

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📋 Eligibility rules (as published)
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: 1. Cr \>=1.8 2. Plt \<50,000, PT-INR \>2 3. Life expectancy \<6 months
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What it tests

  • Middle meningeal artery embolization
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Where

1 site
Hyogo Medical University
Nishinomiya, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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