Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06772740

Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

Led by Kazutaka Uchida · Updated on 2025-05-28

600

Participants Needed

1

Research Sites

222 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Pre-mRS score between 0 and 3
  • Hematoma thickness of 10 mm or greater
  • At least one risk factor including: age 75 or older, antithrombotic therapy, diabetes mellitus, bilateral hematoma, Markwalder grading score greater than 3, preoperative volume 130 ml or greater, preoperative midline shift 8 mm or greater, or specific CT appearances (homogeneous, laminar, or separated)
Not Eligible

You will not qualify if you...

  • Creatinine level 1.8 or higher
  • Platelet count less than 50,000
  • PT-INR greater than 2
  • Life expectancy less than 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hyogo Medical University

Nishinomiya, Hyōgo, Japan, 663-8501

Actively Recruiting

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Research Team

K

Kazutaka Uchida, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma | DecenTrialz