Embolization in Hereditary Coagulopathies

Sponsor
University of Sao Paulo General Hospital
Study ID
NCT05629130
Status
Recruiting
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Conditions

  • Arthropathy
  • Clotting Factor Deficiency
  • Embolization
  • Hemarthrosis
  • Hemophilia
  • Synovitis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • embolization with spherical microparticles embosphere — DEVICE
    embolization of affected joints with spherical microparticles embosphere

Study Details

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.

Key Dates

First listed
Nov 29, 2022
Start date
Jan 16, 2023
Status verified
Sep 2022
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Embolization
    embolization procedure (superselective embolization of target arteries with spherical microparticles Embosphere 100-300 micrometers (Biosphere Medical, Roissy, France) of the affected joint, until partial vascular stasis and decharacterization of pathological synovial enhancement.

Primary Outcome Measure

Reduction of synovium thickness by embolization [ Time Frame: 6 months ]

Central Contacts

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