NCT06809972Recruiting
Synovial Proliferation on Routine Ultrasound: Active or Inactive?
Synovial Proliferation on Routine Ultrasound: Active or Inactive? A Prospective Study
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 46 (estimated)
- First submitted
- 30 Oct 2024
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Van Creveldkliniek
- Diseases
- Haemophilia
- NCT number
- NCT06809972
What you commit to
- Study type: Observational
- Planned participants: 46
- From 1 Jun 2025 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- History of inhibitor development (≥ 5 Bethesda Units\* (BU) at any time or 1-5 BU for
- 1 year prior to inclusion.
Other illness
- Confirmed inflammatory joint diseases such as rheumatoid arthritis or psoriatic arthritis.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.