An interventional study of embolization with spherical microparticles embosphere in Hemophilia, Embolization and Hemarthrosis, sponsored by University of Sao Paulo General Hospital. Recruiting at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
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.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
embolization of affected joints with spherical microparticles embosphere
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
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
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
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
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
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)
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
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).
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
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.
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
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)
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
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)
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Physical capacity
Measure changes in physical capacity by Hemophilia Joint Health Score (HJHS), 0 to 124, 0 being the best result.
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Pain of the affected joint
Measure changes in pain by Hemophilia Joint Health Score (HJHS, 0-12, 0 being the best result)
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
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)
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
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)
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Stifness
Measure (0 to 100, 100 being the best result) changes in knee stiffness by Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2023; primary completion for Dec 2028, 71 months later.
Of 72 non-industry interventional studies with no phase under Hemophilia A, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 38. This study's planned 71 months is above that.
Counting every sponsor, half of 75 studies reached it within 11 months; a quarter within 5 and three quarters within 38.
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