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Clinical Trials in Brazil / NCT05629130
Recruiting Not applicable

Embolization in Hereditary Coagulopathies

NCT05629130 · tracked via the Priya Life Science Brazil tracker
Sponsor
University of Sao Paulo General Hospital
Phase
Not applicable
Started
2023-01-16
Last updated
2022-11-29

Condition(s) studied

HemophiliaEmbolizationHemarthrosisClotting Factor DeficiencySynovitisArthropathy

Investigational drug(s) / intervention(s)

embolization with spherical microparticles embosphere

embolization with spherical microparticles embosphere: embolization of affected joints with spherical microparticles embosphere

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Patients who do not complete the planned assessments * Patients who do not accept to continue with the study.

Primary outcome measure(s)

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05629130 on ClinicalTrials.gov ↗ ← All trials in Brazil