Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

Launched by KAZUTAKA UCHIDA · Jan 9, 2025

Keywords

ClinConnect Summary

The COMPLEMENT study is a clinical trial investigating a new treatment for patients with chronic subdural hematoma, which is a type of bleeding that occurs between the brain and its outer covering. This trial focuses on a procedure called middle meningeal artery embolization, which aims to stop the bleeding and improve patient outcomes. It is designed for adults aged 18 and older who have a certain level of disability before treatment and a significant thickness of the hematoma. Participants will be selected based on specific health factors, such as age, medical history, and the size of the hematoma.

If you or a family member are eligible, you might be invited to take part in this trial. Participants can expect to receive careful monitoring and follow-up to assess the safety and effectiveness of the treatment. The goal is to find out if this new approach can help reduce symptoms and improve recovery for people suffering from this condition. It's important to know that while the trial is currently active, it is not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• 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