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Synovial Proliferation on Routine Ultrasound: Active or Inactive? A Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
University Medical Center Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Lize van Vulpen, MD, PhD
l.f.d.vanvulpen-2@umcutrecht.nl
+31887558450
Backup
Merel Timmer, PhD
m.a.timmer@umcutrecht.nl
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 46
Related Therapeutic Areas
Sponsors
Leads: Van Creveldkliniek

This content was sourced from clinicaltrials.gov