Embolization of the middle meningeal artery for chronic subdural hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COMPLEMENT study is a prospective, open-label, randomized controlled trial designed to evaluate the safety and efficacy of middle meningeal artery embolization in patients suffering from chronic subdural hematoma. This study will involve two arms and will be conducted in Japan, focusing on patients with specific risk factors and hematoma characteristics. Participants will be monitored for outcomes related to their condition following the intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• Hyogo Medical University
  Nishinomiya, Hyōgo, Japan Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Middle Meningeal Artery Embolisation to Prevent Recurrence of Chronic Subdural Hematoma

  This study tests whether embolising the middle meningeal artery around the time of hematoma evacuation can reduce recurrence in adults with chronic subdural hematoma.

  Recruiting at 6 sites University Hospital Hradec Kralove · České Budějovice and 5 other locations · NCT07751887

• What causes vulnerability in older adults with serious diseases and how it affects care decisions

  This study tests how often vulnerability factors appear in older adults with serious illnesses and how these factors influence treatment timing, survival, and quality of life.

  Recruiting Tampere University Hospital · Tampere · NCT07740239

• Coil embolization for unilateral vs bilateral chronic subdural hematomas

  This trial tests whether unilateral or bilateral coil-based embolization of the middle meningeal artery helps people with chronic subdural hematoma.

  Recruiting Lahey Clinic · Burlington, Massachusetts · NCT07715656

• Non-Thermal Plasma Used During Surgery to Help Prevent Recurrent Chronic Subdural Hematoma

  A randomized trial tests whether applying non-thermal plasma during standard surgery to drain a chronic subdural hematoma can reduce recurrence within 6 months.

  Recruiting National Institute of Nuclear Research - Mexico · Ocoyoacac, State of Mexico · NCT07656818

• Anakinra After Endovascular Therapy for Ischemic Stroke

  This trial tests whether giving two doses of Anakinra after successful endovascular treatment can reduce brain damage and improve outcomes in adults with acute ischemic stroke.

  Recruiting at 6 sites Phase 2 Beijing Tiantan Hospital · Beijing, Beijing Municipality and 5 other locations · NCT07423975

• Enhanced recovery pathway for burr-hole drainage in chronic subdural hematoma patients

  This project tests whether an enhanced recovery protocol for adults having burr-hole drainage for chronic subdural hematoma can reduce recurrence and complications compared with past patients.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07421453

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.