Health TrialsbyHealthPanel

Embolization in Hereditary Coagulopathies

ConditionsHemophiliaEmbolizationHemarthrosisClotting Factor DeficiencySynovitisArthropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Sao Paulo General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who do not complete the planned assessments

Patients who do not accept to continue with the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • embolization with spherical microparticles embosphere

    Device

    embolization of affected joints with spherical microparticles embosphere

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: EmbolizationExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
6 months

Secondary outcomes

1

Reduction of synovitis by embolization

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

Time frame
1, 3 12, 24, 36, 48 and 60 months
2

Inferior limb strength

Measure changes in muscle strength by timed up and go (by time of performance, in seconds).

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

Inferior limb strength

Measure changes in muscle strength of lower limbs by 30 seconds sit to stand test (by number of repetitions)

Time frame
1, 3, 6, 12, 24, 36, 48, 60 months
4

Balance and fall risk

Measure (in seconds, period of time to perform the test) changes in balance and risk of falls by Timed up and go test.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Merit Medical Systems, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now