An observational study in Joint Bleed and Hemophilia A, sponsored by Washington Institute for Coagulation. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Washington Institute for Coagulation · Observational
This is a study in 3 phases that will assess the feasibility and utility of handheld home ultrasound (HHUS) in a patient's home to assess whether a painful episode in the elbow, knee or ankle is a bleed or not.
This is a study in 3 phases that will assess the feasibility and utility of handheld home ultrasound (HHUS) in a patient's home to assess whether a painful episode in the elbow, knee or ankle is a bleed or not.
Phase 1 will assess whether 10 subjects with severe hemophilia A can be trained to use HHUS in clinic to identify basic joint structures of the elbow, knee and ankle. It will then assess whether these subjects can identify these structures at home and transmit the images life via tele-ultrasound.
Phase 2 will assess whether the determination of "bleed" vs. "non-bleed" made at home via HHUS can be confirmed/validated with a standard high resolution ultrasound machine in clinic.
Phase 3 will then utilize HHUS during the EmiMSKUS study over 3 years to more objectively identify patient reported bleeding during the study.
21 studies on the registry are indexed under Hemarthrosis; 5 are open to participants now.
Browse Hemarthrosis studies →Washington Institute for Coagulation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Males patients at Hemophilia Treatment Centers with severe Hemophilia A
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
10 male patients with severe Hemophilia A from the Washington Center for Bleeding Disorders
Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform
20 subjects who are also participating in the EmiMSKUS study
Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform
Patients receive training by the physical therapist to operate a handheld ultrasound (HHUS) including proper probe placement. Subjects will be tested on their knowledge at the HTC to demonstrate proficiency, and will then repeat the testing at home via tele-ultrasound.
Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers.
Number of participating subjects who understand basic ultrasound transducer concepts and can perform basic positioning maneuvers based on post-training test.
Time frame: 3 months
Outcome 1.2: Participating subjects are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle.
Number of participating subjects who are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle based on post-training test.
Time frame: 3 months
Outcome 1.3: Participating subjects can perform what they learned during their training at the HTC in outcome 1.1 and outcome 1.2 at home and transmit images to the HTC.
Number of participating subjects who can perform what they learned during their training at the HTC in outcome 1.1 and outcome 1.2 at home and transmit images to the HTC on post-training test.
Time frame: 3 months
Outcome 2.1: Subjects will be able to attain and transmit images of their joint spaces to the HTC via telemedicine utilizing the HHUS technology they learned in phase 1 and React App.
Number of subjects who will be able to attain and transmit images of their joint spaces to the HTC via telemedicine utilizing the HHUS technology they learned in phase 1 and React App.
Time frame: 6 months
Outcome 2.2: Accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.
Percentage accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.
Time frame: 6 months
Outcome 3.1: To establish how accurate patient reported bleeding is compared to HHUS utilizing tele-ultrasound.
Percentage accuracy of patient reported bleeding is compared to HHUS utilizing tele-ultrasound.
Time frame: 3 years
Outcome 3.2: To establish more accurate bleeding data for the EmiMSKUS study.
Number of patients who have joint bleeding data incorporated into the EmiMSKUS study.
Time frame: 3 years
Plan to share: No
Ran from Oct 2019 to primary completion in Jun 2022, 32 months.
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Washington Institute for Coagulation