NCT05629130

Embolization in Hereditary Coagulopathies

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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 Hemophilia do Hospital das Clinicas, Faculdade de Medicina da Universidade de São Paulo, i.e. HC-FMUSP), after approval by the ethics and research committee and registry at the clinical trials. Patients will be evaluated by imaging (X-rays and Magnetic Resonance of the affected joint, i.e., knee, elbow, and/or ankle); physical and functional assessments (Hemophilia Joint Health Score, Functional Independence Score in Hemophilia, Perimeter of the affected joint(s), Test Timed up and Go, 30 second sit and stand test, Knee Injury and Osteoarthritis Outcome Score (KOOS); quality of life (Haemophilia - adult - quality of life questionnaires (HAEM-A-QoL), Knee Injury and Osteoarthritis Outcome Score (KOOS), EQ-5D; pain measured by numerical rating scale. Volunteers will be submitted to embolization procedure (superselective embolization of target arteries with spherical microparticles embosphere 100-300 micrometers (Biosphere Medical, Roissy, France) of the affected joint(s), 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

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

Interventions

Type	Name	Description
DEVICE	embolization with spherical microparticles embosphere	embolization of affected joints with spherical microparticles embosphere

Timeline

• Start date: 2023-01-16
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2022-11-29
• Last updated: 2022-11-29

Locations

1 site across 1 country: Brazil