Embolization treatment for patients with hereditary bleeding disorders
Embolization in Hereditary Coagulopathies
NA · University of Sao Paulo General Hospital · NCT05629130
This study is testing whether a new treatment using tiny particles can help people with hereditary bleeding disorders and joint pain feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital (other) |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05629130 on ClinicalTrials.gov |
What this trial studies
This longitudinal, prospective study aims to evaluate the effects of superselective embolization on patients with hereditary coagulopathies suffering from chronic synovitis due to hemarthrosis in their joints. A total of 30 subjects will undergo imaging tests, physical assessments, and quality of life evaluations at multiple time points over five years. The embolization procedure involves using spherical microparticles to achieve partial vascular stasis in the affected joints, potentially alleviating symptoms and improving joint health. The study will be conducted at the Centro de Hemofilia do Hospital das Clinicas, Faculdade de Medicina da Universidade de São Paulo.
Who should consider this trial
Good fit: Ideal candidates are individuals with hereditary coagulopathies who have chronic synovitis resulting from hemarthrosis in their elbows, knees, or ankles.
Not a fit: Patients who do not complete the planned assessments or decline to participate in the study may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve joint function and quality of life for patients with hereditary coagulopathies.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating joint issues related to coagulopathies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Fabiane E FArias, PT — IOT-HC-FMUSP (Orthopedics Institute - General Hospital- School of Medicine - University of Sao Paulo
- Study coordinator: marcia u rezende, MD PhD
- Email: marcia.uchoa@hc.fm.usp.br
- Phone: +5511 981226282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemophilia, Embolization, Hemarthrosis, Clotting Factor Deficiency, Synovitis, Arthropathy