Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2019-10-01
2022-06-22
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Phase 1 and 2
10 male patients with severe Hemophilia A from the Washington Center for Bleeding Disorders
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.
Phase 3
20 subjects who are also participating in the EmiMSKUS study
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Physically or mentally unable to operate a HHUS unit
18 Years
MALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Washington Institute for Coagulation
OTHER
Responsible Party
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Rebecca Kruse-Jarres, MD, MPH
Executive/Medical Director, Washington Center for Bleeding Disorders
Principal Investigators
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Rebecca Kruse-Jarres, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Washington Institute for Coagulation
Locations
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Washington Center for Bleeding Disorders at Washington Institute for Coagulation
Seattle, Washington, United States
Countries
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References
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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.
Manco-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.
Konkle 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.
Leissinger 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.
Oldenburg 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.
Mahlangu 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.
Zhou 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.
Other Identifiers
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ML41066
Identifier Type: -
Identifier Source: org_study_id
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