Home Blood Transfusions

Официальное название

A Pilot Study of Home Blood Transfusions for Patient With Cancer Who Have Transfusion Dependent Cytopenias

Обзор

This is a pilot single arm study to evaluate the feasibility and acceptability of a home blood transfusion program. Patients will be enrolled with hematologic malignancies and other bone marrow failure syndromes who are transfusion dependent and interested in a home blood transfusion program. Participants enrolled in the study will receive 1-5 units of blood products at home. Data on barriers to administration will be recorded. Surveys and qualitative interviews will be completed to better understand acceptability of the program.

Подробное описание

The study is a single arm pilot study to evaluate the implementation of a novel home blood transfusion program at Thomas Jefferson University Hospital. The study population will include patients with hematologic malignancies and other bone marrow failure syndromes with transfusion dependent cytopenias. Participants will receive home blood draws and if needed same day transfusions. Data will be collected via surveys at time of each study visit, participant surveys at the end of the intervention as well as a semi structured interview. Each participant in the study will receive 1-2 blood products transfused in the home each week for a total of 5 transfusions. As a result each participant will be eligible to receive transfusions at home for 5 weeks.

Вмешательства

• Процедура Home Blood Transfusion
  Participants will be provided with transfusion of blood products, specifically red blood cells and platelets, in the home setting.

Первичные конечные точки

• Feasibility of a home blood transfusion program utilizing the RE-AIM framework [Срок оценки: 5 weeks]
• Acceptability of a home blood transfusion program utilizing the RE-AIM framework [Срок оценки: 5 weeks]

Вторичные конечные точки (1)

• Evaluate patient perspective of home blood transfusions via qualitative analysis. [Срок оценки: Within 3 weeks of final home transfusion]

Критерии участия

Критерии включения

• Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
• Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study
• Male or female, over the age of 18
• Must meet definition of transfusion dependence (require at least 2 blood product transfusions over a 28-day period)
• Receive their cancer care at SKCCC
• Have a history of blood product transfusions and NO history of transfusion reactions,
• Live within a 30-mile range of the Center City SKCCC location.
• Must be willing to allow people into the home

Критерии исключения

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Patients who have a history of a transfusion reaction
• Heart failure as defined by AHA stage C or NYHA Class II-IV
• Non-English or Spanish speaking
• Are unhoused
• Are incarcerated
• Have poor venous access
• Diagnosis of Solid Tumor malignancy
• Women who are pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Thomas Jefferson University Hospital — Philadelphia

Публикации

• Vijenthira A, Starkman R, Lin Y, Stanworth SJ, Bowen D, Harrison L, Wintrich S, Callum J, Buckstein R. Multi-national survey of transfusion experiences and preferences of patients with myelodysplastic syndrome. Transfusion. 2022 Jul;62(7):1355-1364. doi: 10.1111/trf.16946. Epub 2022 Jun 10. PMID 35686926
• Garcia D, Aguilera A, Antolin F, Arroyo JL, Lozano M, Sanroma P, Romon I. Home transfusion: three decades of practice at a tertiary care hospital. Transfusion. 2018 Oct;58(10):2309-2319. doi: 10.1111/trf.14816. Epub 2018 Sep 19. PMID 30229938
• Niscola P, Tendas A, Giovannini M, Cupelli L, Trawinska MM, Palombi M, Scaramucci L, Brunetti GA, Perrotti A, Neri B, Efficace F, Cartoni C, de Fabritiis P, Mandelli F. Transfusions at home in patients with myelodysplastic syndromes. Leuk Res. 2012 Jun;36(6):684-8. doi: 10.1016/j.leukres.2012.01.010. Epub 2012 Feb 14. PMID 22336393
• Charron J, Gouezec H, Bajeux E. [Home blood transfusion in France: Benefits and development terms]. Transfus Clin Biol. 2019 Nov;26(4):304-308. doi: 10.1016/j.tracli.2018.08.161. Epub 2018 Sep 12. French. PMID 30268597
• LeBlanc TW, Egan PC, Olszewski AJ. Transfusion dependence, use of hospice services, and quality of end-of-life care in leukemia. Blood. 2018 Aug 16;132(7):717-726. doi: 10.1182/blood-2018-03-842575. Epub 2018 May 30. PMID 29848484
• Odejide OO, Steensma DP. Patients with haematological malignancies should not have to choose between transfusions and hospice care. Lancet Haematol. 2020 May;7(5):e418-e424. doi: 10.1016/S2352-3026(20)30042-9. PMID 32359453
• Thompson HW, McKelvey J. Home blood transfusion therapy: a home health agency's 5-year experience. Transfusion. 1995 May;35(5):453. doi: 10.1046/j.1537-2995.1995.35595259158.x. No abstract available. PMID 7740619
• Koepke MD, Nyman JA, Koepke JA. Home blood transfusions: the medical, economic, and legal issues surrounding a new treatment procedure. J Health Polit Policy Law. 1988 Fall;13(3):565-79. doi: 10.1215/03616878-13-3-565. PMID 3049774

Идентификаторы

NCT: NCT07121140 · iRISID-2024-1731 · JT 44575

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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