Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKazutaka Uchida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Cr >=1.8
Plt <50,000, PT-INR >2
Life expectancy <6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Middle meningeal artery embolization
Procedure/SurgeryMiddle meningeal artery embolization within 7 days after randomization
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Conventional treatments with middle meningeal artery embolizationExperimental treatment 1 intervention
Group B: Conventional treatments aloneNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of recurrence of chronic subdural hematoma
Recurrence of chronic subdural hematoma is defined as the maximum thickness of subdural hematoma exceeding 10 mm or the patient receiving re-operation.
Time frame
6 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kazutaka Uchida
Lead sponsor
Hyogo Medical University
Sponsor institution
Source ClinicalTrials.gov