RecruitingNot ApplicableNCT05629130

Embolization in Hereditary Coagulopathies

Sponsor

University of Sao Paulo General Hospital

Enrollment

30 participants

Start Date

Jan 16, 2023

Study Type

INTERVENTIONAL

Conditions

Synovitis Hemophilia Arthropathy Embolization Hemarthrosis Clotting Factor Deficiency

Summary

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a minimally invasive procedure called embolization to treat joint disease (arthropathy) in patients with hereditary bleeding disorders such as hemophilia. Repeated joint bleeding causes painful swelling and damage, and this procedure aims to reduce that by blocking small blood vessels feeding the affected joint lining. You may be eligible if: - You have a hereditary bleeding disorder (such as hemophilia) with joint disease caused by repeated bleeding into joints - You have X-ray and MRI evidence of joint inflammation (synovitis) - You are being followed at the Hemophilia Center HC-FMUSP You may NOT be eligible if: - You are unable to complete the planned assessments - You do not wish to continue participating in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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