Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Middle meningeal artery embolization.
- Who it may be relevant to
- Registry conditions: Endovascular Treatment, Chronic Subdural Hematoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
Overview
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.
Interventions
- Procedure Middle meningeal artery embolization
Middle meningeal artery embolization within 7 days after randomization
Primary outcome measures
- Rate of recurrence of chronic subdural hematoma [Time frame: 6 months after randomization]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Cr >=1.8
- Plt <50,000, PT-INR >2
- Life expectancy <6 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Hyogo Medical University — Nishinomiya
Identifiers
NCT: NCT06772740 · R000063204