Embolization in Hereditary Coagulopathies

Hemophilia Clinical Trial

— EHCO  

Official title:

Embolization in Hereditary Coagulopathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629130
• Other study ID #: 63452822.1.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: September 2022
• Source: University of Sao Paulo General Hospital
• Contact: marcia u rezende, MD PhD
• Phone: +5511 981226282
• Email: marcia.uchoa[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 Hemophilia do Hospital das Clinicas, Faculdade de Medicina da Universidade de São Paulo, i.e. HC-FMUSP), after approval by the ethics and research committee and registry at the clinical trials. Patients will be evaluated by imaging (X-rays and Magnetic Resonance of the affected joint, i.e., knee, elbow, and/or ankle); physical and functional assessments (Hemophilia Joint Health Score, Functional Independence Score in Hemophilia, Perimeter of the affected joint(s), Test Timed up and Go, 30 second sit and stand test, Knee Injury and Osteoarthritis Outcome Score (KOOS); quality of life (Haemophilia - adult - quality of life questionnaires (HAEM-A-QoL), Knee Injury and Osteoarthritis Outcome Score (KOOS), EQ-5D; pain measured by numerical rating scale. Volunteers will be submitted to embolization procedure (superselective embolization of target arteries with spherical microparticles embosphere 100-300 micrometers (Biosphere Medical, Roissy, France) of the affected joint(s), 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy
• Embolization
• Hemarthrosis
• Hemophilia
• Synovitis

Intervention

Device:
• embolization with spherical microparticles embosphere
embolization of affected joints with spherical microparticles embosphere

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Merit Medical Systems, Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of synovitis by embolization	Measure (in milimeters) changes on synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI	1, 3 12, 24, 36, 48 and 60 months
Secondary	Inferior limb strength	Measure changes in muscle strength by timed up and go (by time of performance, in seconds).	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Inferior limb strength	Measure changes in muscle strength of lower limbs by 30 seconds sit to stand test (by number of repetitions)	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	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.	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Quality of life of the patient	Measure, according to the scale of the questionnaire, changes in quality of life with Haemophilia - Adult - Quality of life Questionnaires (HAEM-A-QoL, 10 dimensions, 0 to 100, being 0 the best health related quality of life)	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Quality of life of the patient	Measure, according to the scale of the questionnaire, changes in quality of life with Knee Injury and Osteoarthritis Outcome Score (KOOS, 0-100, 100 being the best quality of life).	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Quality of life of the patient	Measure, according to the scale of the questionnaire, changes in quality of life with by EQ-5D, up to 1, being 1 the best quality of life). Please note: "Since 2009, EQ-5D has been available in three versions: the three-level EQ-5D-3L; the five-level EQ-5D-5L; and a 'youth' adaptation, EQ-5D-Y. Although the EQ is in recognition of the EuroQol group name, the D refers to dimensions, the L signifies level, and the Y stands for youth, the name of the instrument should not be spelled out in this manner as this is inaccurate. Therefore, EQ-5D is not an abbreviation and is the correct term to use when referring to the instrument in general." Brooks R, Boye KS, Slaap B. EQ-5D: a plea for accurate nomenclature. J Patient Rep Outcomes. 2020 Jul 3;4(1):52. doi: 10.1186/s41687-020-00222-9. PMID: 32620995; PMCID: PMC7334333.	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Functional capacity	Measure (according to the scale of the questionnaire) changes in functional capacity with Functional Independence Score in Hemophilia (FISH score, 0 to 32, 32 being the best result)	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Functional capacity	Measure (according to the scale of the questionnaire) changes in functional capacity with Functional Independence Score by Knee Injury and Osteoarthritis Outcome Score (KOOS, 0-100, 100 being the best result)	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Physical capacity	Measure changes in physical capacity by Hemophilia Joint Health Score (HJHS), 0 to 124, 0 being the best result.	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Pain of the affected joint	Measure changes in pain by Hemophilia Joint Health Score (HJHS, 0-12, 0 being the best result)	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Pain of the affected joint	Measure changes in pain by numerical rating scale (NRS, 0-10, 0 being no pain and 10 being the worst pain possible)	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Pain of the affected joint	Measure changes in pain by Knee Injury and Osteoarthritis Outcome Score (KOOS, 0 to 100, 100 being the best result)	1, 3, 6, 12, 24, 36, 48, 60 months
Secondary	Stifness	Measure (0 to 100, 100 being the best result) changes in knee stiffness by Knee Injury and Osteoarthritis Outcome Score (KOOS)	1, 3, 6, 12, 24, 36, 48, 60 months