HemophiliaEHCONCT05629130
Embolization in Hereditary Coagulopathies
A study testing embolization with spherical microparticles embosphere in people with Hemophilia and Embolization, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia, Embolization, Hemarthrosis
- What is being tested?
- embolization with spherical microparticles embosphere
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jan 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not complete the planned assessments
- Patients who do not accept to continue with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-010
Marcia U Rezende, MD, PhD, 551130625531, marcia.uchoa@hc.fm.usp.br
Fabiane P Farias, PT, 55112661-2473, fabiane.elize@hc.fm.usp.br
About this study
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.
Read the detailed 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.
- Conditions
- Hemophilia, Embolization, Hemarthrosis, Clotting Factor Deficiency, Synovitis, Arthropathy
- Being tested
- embolization with spherical microparticles embosphere
- Medical subject headings
- Hemophilia A, Hemarthrosis, Synovitis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolization with spherical microparticles embosphereDevice
embolization of affected joints with spherical microparticles embosphere
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: embolization with spherical microparticles embosphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (14)
Reduction of synovitis by embolization
Measure (in milimeters) changes on synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1, 3, 6, 12, 24, 36, 48, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start16 Jan 2023 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- longitudinal, prospective study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merit Medical Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Fabiane E FArias, PT, Principal investigator, IOT-HC-FMUSP (Orthopedics Institute - General Hospital- School of Medicine - University of Sao PauloAndre M Assis, MD, PhD, Study director, Radiology Insititute, General Hospital, School Medicine, University of São PauloPaula Villaça, MD, PhD, Study director, Hematology department, General Hospital, School of Medicine, University of Sâo Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629130
- Sponsor's protocol ID
- 63452822.1.0000.0068
- Acronym
- EHCO
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embolization in Hereditary Coagulopathies
- ClinicalTrials.gov ID
- NCT05629130
- Acronym / sponsor ID
- EHCO / 63452822.1.0000.0068
- Conditions
- Hemophilia, Embolization, Hemarthrosis, Clotting Factor Deficiency, Synovitis, Arthropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Merit Medical Systems, Inc.
- Study start
- 16 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- longitudinal, prospective study.
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Device: embolization with spherical microparticles embosphereembolization 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who do not complete the planned assessments
- Patients who do not accept to continue with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embolization with spherical microparticles embosphereembolization of affected joints with spherical microparticles embosphere | Device | Embolization |
Primary outcome
Reduction of synovium thickness by embolization
Time frame: 6 months
Measure (in milimeters) changes of synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI (measure synovium thickness)
14 secondary outcomes
Reduction of synovitis by embolization
Time frame: 1, 3 12, 24, 36, 48 and 60 months
Inferior limb strength
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Inferior limb strength
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Balance and fall risk
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Quality of life of the patient
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Quality of life of the patient
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Quality of life of the patient
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Functional capacity
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Functional capacity
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Physical capacity
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Pain of the affected joint
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Pain of the affected joint
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Pain of the affected joint
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Stifness
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabiane E FArias, PT principal investigator
IOT-HC-FMUSP (Orthopedics Institute - General Hospital- School of Medicine - University of Sao Paulo
Andre M Assis, MD, PhD study director
Radiology Insititute, General Hospital, School Medicine, University of São Paulo
Paula Villaça, MD, PhD study director
Hematology department, General Hospital, School of Medicine, University of Sâo Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embolization with spherical microparticles embosphere in people with Hemophilia and Embolization, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact marcia u rezende, MD PhD (+5511 981226282, marcia.uchoa@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of synovium thickness by embolization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.