Actively Recruiting
Embolization in Hereditary Coagulopathies
Led by University of Sao Paulo General Hospital · Updated on 2022-11-29
30
Participants Needed
1
Research Sites
363 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
M
Merit Medical Systems, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a longitudinal, prospective study, which will include 30 subjects with hereditary coagulopathies, with arthropathy, chronic synovitis resulting from hemarthrosis of the elbows, knees and/or ankles followed up at the Centro de Hemofilia HCFMUSP, after approval by the ethics and research committee. They will undergo imaging tests (X-rays and Magnetic Resonance of knee, elbow, or ankle), physical, pain, quality of life and functional assessments (Hemophilia Joint Health Score, Functional Independence Score in Hemophilia, Perimeter, Test Timed up and Go, 30 second sit and stand test, Haemophilia - Adult - Quality of Life questionnaire (HAEM-A-QoL), Knee Injury and Osteoarthritis Outcome Score, EQ-5D, numerical rating scale for pain and embolization procedure (superselective embolization of target arteries with spherical microparticles Embosphere 100-300 micrometers (Biosphere Medical, Roissy, France), until partial vascular stasis and decharacterization of pathological synovial enhancement. These evaluations will be performed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.
CONDITIONS
Official Title
Embolization in Hereditary Coagulopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hereditary coagulopathies and arthropathy caused by chronic synovitis from hemarthrosis
- X-ray and MRI documenting synovitis of the affected joints
- Patients followed up at the Hemophilia Center HC-FMUSP
You will not qualify if you...
- Patients who do not complete the planned assessments
- Patients who do not accept to continue with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Actively Recruiting
Research Team
M
marcia u rezende, MD PhD
CONTACT
F
Fabiane E Farias, PT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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