Chronic Subdural Hematoma, Endovascular Treatment
Conditions
Brief summary
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
PROCEDUREMiddle meningeal artery embolization
Middle meningeal artery embolization within 7 days after randomization
Sponsors
Kazutaka Uchida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrence of chronic subdural hematoma | 6 months after randomization | Recurrence of chronic subdural hematoma is defined as the maximum thickness of subdural hematoma exceeding 10 mm or the patient receiving re-operation. |
Countries
Japan
Contacts
CONTACTKazutaka Uchida, MD, PhD
Outcome results
None listed