Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02634918 · ClinicalTrials.gov registry record
Ultrasonography in Hemophilic Joint Disease and Serum Markers
A clinical trial, sponsored by Northwell Health.
- Completed
- Registry status
- 30
- Enrollment target
NCT02634918 is a clinical trial that has completed, run by Northwell Health. The registered enrollment target is 30 participants.
The verdict
NCT02634918 has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
Hemophilia is a bleeding disorder (deficiency of a blood clotting factor/ protein) resulting in bleeding in joints and muscles. As patients continue to bleed into their joints they develop progressive joint damage leading to joint contractures, disability and days missed from work and school resulting in chronic debilitating pain and compromised quality of life. Current therapy is the administration of the missing protein or factor concentrate on a scheduled basis to prevent bleeding into the joints referred to as prophylaxis. This factor concentrate is expensive \~ $ 3,000 - 6,000 per infusion/ week in a child weighing 20 kg translating into $ 77,000 /yr for life. This regimen has been shown to be effective to prevent joint bleeds but the timing is unclear and not based on adequate evidence. Currently joint damage is diagnosed using MRI which is expensive and requires sedation in children \< 6 yrs of age. Therefore there is a need for a user friendly tool such as a ultrasound to monitor for the development of joint disease and tailor treatment based on an individual child's needs. This would also enable differentiating a joint bleed from a soft tissue bleed which present similarly and duration of treatment tends to be longer for a joint bleed. Acharya et al have previously shown that ultrasound is comparable to MRI for the diagnosis of hemophilic joint disease in hemophilia patients over the age of 6 years. However, the diagnostic findings in children \< 18 years with hemophilia on ultrasound is not well defined(1). The hemophilic synovium after repeated joint bleeds reveals the development of new vessels which are fragile and contribute to recurrent joint bleeds. Acharya et al have previously shown that angiogenesis, a process of new vessel formation is active in hemophilic synovium and angiogenic markers were significantly elevated in hemophilic patients with joint disease when compared to those without (2). Since ultrasound can detect these new vessel changes i
Interventions
- OTHER ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02634918
The ClinicalTrials.gov registry entry for NCT02634918 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ultrasound is the first listed.
NCT02634918 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02634918 about?
NCT02634918 is a clinical study titled "Ultrasonography in Hemophilic Joint Disease and Serum Markers". Hemophilia is a bleeding disorder (deficiency of a blood clotting factor/ protein) resulting in bleeding in joints and muscles. As patients continue to bleed into their joints they develop progressive joint damage leading to joint contractures, disability and days missed from work and school resulti...
What is the current status of trial NCT02634918?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2016-01. Estimated completion is 2019-12.
What interventions are being tested in trial NCT02634918?
The interventions under investigation include: ultrasound (OTHER).
Who is sponsoring clinical trial NCT02634918?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.