Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

Kazutaka Uchida600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Endovascular Treatment Chronic Subdural Hematoma

Interventions

Middle meningeal artery embolizationPROCEDURE

Middle meningeal artery embolization within 7 days after randomization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hyogo Medical University

Nishinomiya, Hyōgo, Japan

RECRUITING

Outcomes

Primary Outcomes

Rate of recurrence of chronic subdural hematoma

Recurrence of chronic subdural hematoma is defined as the maximum thickness of subdural hematoma exceeding 10 mm or the patient receiving re-operation.

Time frame: 6 months after randomization

Central Contacts

Kazutaka Uchida, MD, PhD

CONTACT

81+798-45-6458 fu-sakakibara@hyo-med.ac.jp

Data from ClinicalTrials.gov

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