Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

NCT06772740 | Recruiting DMC

• 1 other identifier: R000063204
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endovascular Treatment; Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after randomization

Study Arms (2)

Conventional treatments with middle meningeal artery embolization

EXPERIMENTAL

Procedure: Middle meningeal artery embolization

Conventional treatments alone

NO INTERVENTION

Interventions

Middle meningeal artery embolization PROCEDURE

Middle meningeal artery embolization within 7 days after randomization

Conventional treatments with middle meningeal artery embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Cr \>=1.8
• Plt \<50,000, PT-INR \>2
• Life expectancy \<6 months

Sponsors & Collaborators

• Kazutaka Uchida: lead

Study Sites (1)

Hyogo Medical University

Nishinomiya, Hyōgo, 663-8501, Japan

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Central Study Contacts

Kazutaka Uchida, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor (Stroke Center)

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: December 23, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)