Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma
Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
Kazutaka Uchida
600 participants
Dec 23, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Age \>=18
- pre-mRS 0-3
- Hematoma thickness \>=10mm
- 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 Criteria3
- Cr \>=1.8
- Plt \<50,000, PT-INR \>2
- Life expectancy \<6 months
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Interventions
Middle meningeal artery embolization within 7 days after randomization
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06772740