Synovial Proliferation on Routine Ultrasound: Active or Inactive?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age12+
SponsorVan Creveldkliniek
About this trial
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).
Eligibility criteria
Qualifiers
Gender: male
Patients with severe haemophilia A or B
Treated with registered prophylaxis medication including coagulation factors and by- passing agents.
Age ≥ 12 years
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ultrasound imaging
Treatment groups
No treatment groups listed
Sponsors and collaborators
Van Creveldkliniek
Lead sponsor
UMC Utrecht
Sponsor institution
Source ClinicalTrials.gov