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NCT05629130Recruiting

Embolization in Hereditary Coagulopathies

Source: ClinicalTrials.gov · Last updated 29 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
28 Sept 2022
Start date
16 Jan 2023
Primary completion date
31 Dec 2028
Lead sponsor
University of Sao Paulo General Hospital
Diseases
Haemophilia
NCT number
NCT05629130

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 16 Jan 2023 to the primary completion date, 31 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patients who do not complete the planned assessments
  • Patients who do not accept to continue with the study.

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.