Joint BleedHHUSNCT04131920
Handheld Ultrasound (HHUS) for Home Use in Hemophilia
An observational study of Joint Bleed and Hemophilia A, run by Washington Institute for Coagulation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Joint Bleed, Hemophilia A
- What is being tested?
- handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 22 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males patients at Hemophilia Treatment Centers with severe Hemophilia A
Who may be able to join
- Severe hemophilia A
- Male
- Over 18 years of age
- Able to read, write and understand English
- Willing to come to the center for an 8 hour training session
- Lives in proximity of the HTC and is willing to come in for acute joint episodes in phase 2
Show all 9Show fewer
- Willing and able to follow study procedures
- Willing and able to keep HHUS at a safe place
- Have the dexterity to operate a HHUS unit
Who cannot join
- Unable to follow study instructions
- Physically or mentally unable to operate a HHUS unit
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Center for Bleeding Disorders at Washington Institute for Coagulation
Seattle, Washington, 98101
About this study
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.
Read the detailed description
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.
- Conditions
- Joint Bleed, Hemophilia A
- Being tested
- handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform
- Keywords
- Joint Bleed, Hemophilia A, Handheld Ultrasound
- Medical subject headings
- Hemarthrosis, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 and 2 | 10 male patients with severe Hemophilia A from the Washington Center for Bleeding Disorders Receives: Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform | |
| Phase 3 | 20 subjects who are also participating in the EmiMSKUS study Receives: Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Oct 2019
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Joint BleedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington Institute for Coagulation
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Rebecca Kruse-Jarres, MD, MPH, Washington Institute for Coagulation
- Investigators
- Rebecca Kruse-Jarres, MD, MPH, Principal investigator, Washington Institute for Coagulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131920
- Sponsor's protocol ID
- ML41066
- Acronym
- HHUS
- Status last verified
- Jun 2022
- First submitted
- 14 Oct 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Forsyth AL, Giangrande P, Hay CR, Kenet G, Kessler CM, Knobl PN, Llinas A, Santagostino E, Young G. Difficult clinical challenges in haemophilia: international experiential perspectives. Haemophilia. 2012 Jul;18 Suppl 5:39-45. doi: 10.1111/j.1365-2516.2012.02887.x.
PubMed 22757683Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, Ingram JD, Manco-Johnson ML, Funk S, Jacobson L, Valentino LA, Hoots WK, Buchanan GR, DiMichele D, Recht M, Brown D, Leissinger C, Bleak S, Cohen A, Mathew P, Matsunaga A, Medeiros D, Nugent D, Thomas GA, Thompson AA, McRedmond K, Soucie JM, Austin H, Evatt BL. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007 Aug 9;357(6):535-44. doi: 10.1056/NEJMoa067659.
PubMed 17687129Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13. doi: 10.1111/j.1538-7836.2007.02663.x.
PubMed 17723130Leissinger C, Gringeri A, Antmen B, Berntorp E, Biasoli C, Carpenter S, Cortesi P, Jo H, Kavakli K, Lassila R, Morfini M, Negrier C, Rocino A, Schramm W, Serban M, Uscatescu MV, Windyga J, Zulfikar B, Mantovani L. Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors. N Engl J Med. 2011 Nov 3;365(18):1684-92. doi: 10.1056/NEJMoa1104435.
PubMed 22047559Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-818. doi: 10.1056/NEJMoa1703068. Epub 2017 Jul 10.
PubMed 28691557Mahlangu et al. Emicizumab prophylaxis administered once-weekly or every two weeks provides effective bleed prevention in persons with haemophilia A without inhibitors - Results from the phase III HAVEN 3 study . Oral presented at the World Federation of Hemophilia Meeting in Glasgow, May 21, 2018.
Ceponis A, Wong-Sefidan I, Glass CS, von Drygalski A. Rapid musculoskeletal ultrasound for painful episodes in adult haemophilia patients. Haemophilia. 2013 Sep;19(5):790-8. doi: 10.1111/hae.12175. Epub 2013 May 15.
PubMed 23672827Zhou JY, Rappazzo KC, Volland L, Barnes RFW, Brackman M, Steiner B, Kruse-Jarres R, Quon DV, Bailey C, Chang EY, von Drygalski A. Pocket handheld ultrasound for evaluation of the bleeding haemophilic joint: A novel and reliable way to recognize joint effusions. Haemophilia. 2018 Mar;24(2):e77-e80. doi: 10.1111/hae.13429. Epub 2018 Feb 12. No abstract available.
PubMed 29436079
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handheld Ultrasound (HHUS) for Home Use in Hemophilia
- ClinicalTrials.gov ID
- NCT04131920
- Acronym / sponsor ID
- HHUS / ML41066
- Conditions
- Joint Bleed, Hemophilia A
- Keywords
- Joint Bleed, Hemophilia A, Handheld Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington Institute for CoagulationUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 and 2 | – | Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform10 male patients with severe Hemophilia A from the Washington Center for Bleeding Disorders |
| Phase 3 | – | Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform20 subjects who are also participating in the EmiMSKUS study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males patients at Hemophilia Treatment Centers with severe Hemophilia A
Key inclusion criteria (9 listed)
- Severe hemophilia A
- Male
- Over 18 years of age
- Able to read, write and understand English
- Willing to come to the center for an 8 hour training session
Key exclusion criteria (2 listed)
- Unable to follow study instructions
- Physically or mentally unable to operate a HHUS unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platformPatients 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. | Device | Phase 1 and 2, Phase 3 |
Primary outcome
Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers.
Time frame: 3 months
Number of participating subjects who understand basic ultrasound transducer concepts and can perform basic positioning maneuvers based on post-training test.
Outcome 1.2: Participating subjects are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle.
Time frame: 3 months
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.
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.
Time frame: 3 months
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.
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.
Time frame: 6 months
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.
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.
Time frame: 6 months
Percentage accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.
Outcome 3.1: To establish how accurate patient reported bleeding is compared to HHUS utilizing tele-ultrasound.
Time frame: 3 years
Percentage accuracy of patient reported bleeding is compared to HHUS utilizing tele-ultrasound.
Outcome 3.2: To establish more accurate bleeding data for the EmiMSKUS study.
Time frame: 3 years
Number of patients who have joint bleeding data incorporated into the EmiMSKUS study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Background: PubMed 22757683Forsyth AL, Giangrande P, Hay CR, Kenet G, Kessler CM, Knobl PN, Llinas A, Santagostino E, Young G. Difficult clinical challenges in haemophilia: international experiential perspectives. Haemophilia. 2012 Jul;18 Suppl 5:39-45. doi: 10.1111/j.1365-2516.2012.02887.x.
- Background: PubMed 17687129Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, Ingram JD, Manco-Johnson ML, Funk S, Jacobson L, Valentino LA, Hoots WK, Buchanan GR, DiMichele D, Recht M, Brown D, Leissinger C, Bleak S, Cohen A, Mathew P, Matsunaga A, Medeiros D, Nugent D, Thomas GA, Thompson AA, McRedmond K, Soucie JM, Austin H, Evatt BL. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007 Aug 9;357(6):535-44. doi: 10.1056/NEJMoa067659.
- Background: PubMed 17723130Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13. doi: 10.1111/j.1538-7836.2007.02663.x.
- Background: PubMed 22047559Leissinger C, Gringeri A, Antmen B, Berntorp E, Biasoli C, Carpenter S, Cortesi P, Jo H, Kavakli K, Lassila R, Morfini M, Negrier C, Rocino A, Schramm W, Serban M, Uscatescu MV, Windyga J, Zulfikar B, Mantovani L. Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors. N Engl J Med. 2011 Nov 3;365(18):1684-92. doi: 10.1056/NEJMoa1104435.
- Background: PubMed 28691557Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-818. doi: 10.1056/NEJMoa1703068. Epub 2017 Jul 10.
- BackgroundMahlangu et al. Emicizumab prophylaxis administered once-weekly or every two weeks provides effective bleed prevention in persons with haemophilia A without inhibitors - Results from the phase III HAVEN 3 study . Oral presented at the World Federation of Hemophilia Meeting in Glasgow, May 21, 2018.
- Background: PubMed 23672827Ceponis A, Wong-Sefidan I, Glass CS, von Drygalski A. Rapid musculoskeletal ultrasound for painful episodes in adult haemophilia patients. Haemophilia. 2013 Sep;19(5):790-8. doi: 10.1111/hae.12175. Epub 2013 May 15.
- Background: PubMed 29436079Zhou JY, Rappazzo KC, Volland L, Barnes RFW, Brackman M, Steiner B, Kruse-Jarres R, Quon DV, Bailey C, Chang EY, von Drygalski A. Pocket handheld ultrasound for evaluation of the bleeding haemophilic joint: A novel and reliable way to recognize joint effusions. Haemophilia. 2018 Mar;24(2):e77-e80. doi: 10.1111/hae.13429. Epub 2018 Feb 12. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Kruse-Jarres, MD, MPH principal investigator
Washington Institute for Coagulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Bleed and Hemophilia A, run by Washington Institute for Coagulation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers. (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131920, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.