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Embolization in Hereditary Coagulopathies

NCT05629130 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-29

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

embolization with spherical microparticles embosphere

embolization of affected joints with spherical microparticles embosphere

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    collaborator INDUSTRY

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Fabiane E FArias, PT · IOT-HC-FMUSP (Orthopedics Institute - General Hospital- School of Medicine - University of Sao Paulo

  • Andre M Assis, MD, PhD · Radiology Insititute, General Hospital, School Medicine, University of São Paulo

  • Paula Villaça, MD, PhD · Hematology department, General Hospital, School of Medicine, University of Sâo Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629130 on ClinicalTrials.gov