Embolization in Hereditary Coagulopathies

NCT05629130 | Recruiting

• 1 other identifier: 63452822.1.0000.0068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Reduction of synovium thickness by embolization

  Measure (in milimeters) changes of synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI (measure synovium thickness)

  6 months

Secondary Outcomes (14)

• Reduction of synovitis by embolization

  1, 3 12, 24, 36, 48 and 60 months

• Inferior limb strength

  1, 3, 6, 12, 24, 36, 48, 60 months

• Inferior limb strength

  1, 3, 6, 12, 24, 36, 48, 60 months

• Balance and fall risk

  1, 3, 6, 12, 24, 36, 48, 60 months

• Quality of life of the patient

  1, 3, 6, 12, 24, 36, 48, 60 months

Study Arms (1)

Embolization

EXPERIMENTAL

embolization procedure (superselective embolization of target arteries with spherical microparticles Embosphere 100-300 micrometers (Biosphere Medical, Roissy, France) of the affected joint, until partial vascular stasis and decharacterization of pathological synovial enhancement.

Device: embolization with spherical microparticles embosphere

Interventions

embolization with spherical microparticles embosphere DEVICE

embolization of affected joints with spherical microparticles embosphere

Embolization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Merit Medical Systems, Inc.: collaborator

Study Sites (1)

Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-010, Brazil

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Hemarthrosis; Synovitis; Joint Diseases

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Fabiane E FArias, PT

  IOT-HC-FMUSP (Orthopedics Institute - General Hospital- School of Medicine - University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Andre M Assis, MD, PhD

  Radiology Insititute, General Hospital, School Medicine, University of São Paulo

  STUDY DIRECTOR

• Paula Villaça, MD, PhD

  Hematology department, General Hospital, School of Medicine, University of Sâo Paulo

  STUDY DIRECTOR

Central Study Contacts

marcia u rezende, MD PhD

CONTACT

+5511 981226282; marcia.uchoa@hc.fm.usp.br

Fabiane E Farias, PT

CONTACT

+ 5511 3062-5531; fabiane.elize@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking - all treatement
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: longitudinal, prospective study.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: November 29, 2022
• Study Start: January 16, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)