Embolization of the middle meningeal artery for chronic subdural hematoma
Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
This study is testing if blocking a specific artery can help people with chronic subdural hematomas feel better and recover safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hyogo Medical University Academic / other |
| Locations | 1 site (Nishinomiya, Hyōgo) |
| Trial ID | NCT06772740 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic subdural hematoma and specific risk factors.
Not a fit: Patients with severe renal impairment, low platelet counts, or a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with chronic subdural hematoma.
How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in the treatment of chronic subdural hematoma using embolization techniques.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nishinomiya, Hyōgo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.