Actively Recruiting
Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
Led by Kazutaka Uchida · Updated on 2025-05-28
600
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The COMPLEMENT study is a Japanese clinical trial investigating treatments for patients with chronic subdural hematoma, a condition involving blood collection on the brain's surface. This research compares the safety and effectiveness of adding middle meningeal artery embolization to conventional treatments. The study is randomized, open-label, and uses blinded endpoint evaluation to ensure objective results. Participants are randomly assigned to receive either conventional treatment alone or conventional treatment plus middle meningeal artery embolization performed within 7 days after randomization. This procedure aims to reduce the chance of hematoma recurrence by blocking specific blood vessels. The study includes two groups to compare outcomes directly. Throughout the study, researchers will monitor participants for six months after randomization to measure the rate of hematoma recurrence. Various clinical assessments will be conducted to evaluate participants' health status, including neurological function and imaging studies. Safety and efficacy data will be collected to determine the benefits and risks of the embolization procedure during this period.
CONDITIONS
Brief Title
Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Modified Rankin Scale (pre-mRS) score between 0 and 3
- Hematoma thickness 10 mm or greater
- Having at least one risk factor: age 75 or older, antithrombotic therapy, diabetes mellitus, bilateral hematoma, Markwalder grading score above 3, preoperative volume 130 ml or greater, preoperative midline shift 8 mm or greater, or CT appearance (homogeneous, laminar, or separated)
You will not qualify if you...
- Creatinine level 1.8 or higher
- Platelet count less than 50,000
- Prothrombin time-international normalized ratio (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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 7 days after randomization
Participants undergo middle meningeal artery embolization within 7 days after randomization.
1 procedure visit (in-person)
Duration - 6 months after randomization
Participants are monitored for recovery and recurrence of chronic subdural hematoma.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Hyogo Medical University
Nishinomiya, Hyōgo, Japan, 663-8501
Actively Recruiting
Research Team
K
Kazutaka Uchida, MD, PhD
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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