Synovial Proliferation on Routine Ultrasound: Active or Inactive?

NCT ID: NCT06809972

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-12-21

Brief Summary

There is cumulating evidence for the presence of non-observed or subclinical joint bleeding in patients with haemophilia. Early detection of active subclinical synovial proliferation would allow early intervention in order to prevent deterioration of joint health. Patients with subclinical (=non-observed) signs of synovial proliferation in knee(s), ankle(s) and/or elbow(s) will be invited to participate in this study to further characterize the synovial proliferation status (active or inactive) by means of physical examination, MRI, ultrasound and elastography. Synovial proliferation status will be monitored for a maximum period of 12 weeks, during which participants will also receive standard-of-care treatment, i.e. administration of optimized coagulation factor replacement therapy and prescription of the NSAID celecoxib (optional).

Detailed Description

To be completed

Conditions

Haemophilia; Hemophilia A; Hemophilia B

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasound imaging

Ultrasound, MRI and elastography to screen for and follow subclinical synovial changes in ankle, elbow and knee.

Intervention Type: OTHER

Other Intervention Names

MRI; Elastography

Eligibility Criteria

Inclusion Criteria

• Gender: male
• Patients with severe haemophilia A or B
• Treated with registered prophylaxis medication including coagulation factors and by- passing agents.
• Age ≥ 12 years
• Subclinical synovial proliferation in ≥1 joint (ankle, knee and/or elbow), defined as the presence of hypertrophic synovium, score >0 according to the HEAD-US protocol, as confirmed during routine ultrasound screening.
• Able to give written informed consent.

Exclusion Criteria

• A major bleed ≤ 3 months or a minor bleed ≤ 1 month prior to inclusion in the joint of interest.
• On demand therapy.
• Currently treated with any type of haemophilia prophylaxis medication.
• Joints with prosthesis or treated with arthrodesis will not be included for physical examination and ultrasound analysis. However, participants may still be included in the study with their other joints.
• Confirmed inflammatory joint diseases such as rheumatoid arthritis or psoriatic arthritis.
• History of inhibitor development (≥ 5 Bethesda Units* (BU) at any time or 1-5 BU for

• 1 year prior to inclusion.
• Contra-indication for treatment with NSAIDs, (allergy, severe liver failure, renal failure (GFR <30ml/min), congestive heart failure (NYHA II-IV), peripheral arterial disease and/or cerebrovascular disease.

• Minimum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Van Creveldkliniek

OTHER

Sponsor Role: lead

Responsible Party

Van Creveldkliniek

Center for Benign Hematology, Thrombosis and Haemostasis

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lize van Vulpen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht - Van Creveldkliniek

Locations

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

Netherlands

Central Contacts

Lize van Vulpen, MD, PhD

Role: CONTACT

l.f.d.vanvulpen-2@umcutrecht.nl

+31887558450

Merel Timmer, PhD

Role: CONTACT

m.a.timmer@umcutrecht.nl

Facility Contacts

Lize van, MD, PhD

Role: primary

l.f.d.vanvulpen-2@umcutrecht.nl

+31887558450

Other Identifiers

2BEGIN

Identifier Type: -

Identifier Source: org_study_id