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)

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 Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma; Endovascular Treatment
• Intervention / Treatment: Procedure: Middle meningeal artery embolization

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kazutaka Uchida, MD, PhD; Phone Number: 81+798-45-6458; Email: fu-sakakibara@hyo-med.ac.jp

Study Locations

• Japan
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 663-8501
      • Recruiting
      • Hyogo Medical University
      • Contact: Kazutaka Uchida, MD, PhD; Phone Number: +81-798-45-6458; Email: fu-sakakibara@hyo-med.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional treatments with middle meningeal artery embolization	Procedure: Middle meningeal artery embolization; Middle meningeal artery embolization within 7 days after randomization
No Intervention: Conventional treatments alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kazutaka Uchida

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
• Other Study ID Numbers: R000063204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No