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

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

Inclusion Criteria1

  • Patients with hereditary coagulopathies with arthropathy (i.e., chronic synovitis due to hemarthrosis), with X-ray and MRI (documenting synovitis) followed up at the Hemophilia Center HC-FMUSP.

Exclusion Criteria2

  • Patients who do not complete the planned assessments
  • Patients who do not accept to continue with the study.

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Interventions

DEVICEembolization with spherical microparticles embosphere

embolization of affected joints with spherical microparticles embosphere


Locations(1)

Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

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NCT05629130


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