Embolization in Hereditary Coagulopathies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: embolization with spherical microparticles embosphere.
- Who it may be relevant to
- Registry conditions: Hemophilia, Embolization, Hemarthrosis, Clotting Factor Deficiency. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device embolization with spherical microparticles embosphere
embolization of affected joints with spherical microparticles embosphere
Primary outcome measures
- Reduction of synovium thickness by embolization [Time frame: 6 months]
Secondary outcome measures (12)
- Reduction of synovitis by embolization [Time frame: 1, 3 12, 24, 36, 48 and 60 months]
- Inferior limb strength [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Inferior limb strength [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Balance and fall risk [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Quality of life of the patient [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Quality of life of the patient [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Quality of life of the patient [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Functional capacity [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Functional capacity [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Physical capacity [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Pain of the affected joint [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Pain of the affected joint [Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina d — São Paulo
Identifiers
NCT: NCT05629130 · 63452822.1.0000.0068