Home Blood Transfusions

NCT07121140 | Recruiting

• 2 other identifiers: iRISID-2024-1731JT 44575
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelodysplastic Syndromes; Acute Myeloid Leukemia; Transfusion Dependent Cytopenias; Hematologic Malignancy

Keywords

home blood transfusions; blood transfusions; RE-AIM; Supportive Care

Outcome Measures

Primary Outcomes (2)

• Feasibility of a home blood transfusion program utilizing the RE-AIM framework

  The feasibility of the program defined as greater than 80% of home blood product transfusions occur as planned.

  5 weeks

• Acceptability of a home blood transfusion program utilizing the RE-AIM framework

  Surveys and qualitative interviews will be completed to better understand acceptability of the program. Acceptability will be measured using the acceptability of intervention measure. Based on a 5-point Likert scale. Score range: 1 (Completely Disagree) to 5 (Completely Agree)

  5 weeks

Secondary Outcomes (1)

• Evaluate patient perspective of home blood transfusions via qualitative analysis.

  Within 3 weeks of final home transfusion

Study Arms (1)

Experimental - Home Blood Transfusion

EXPERIMENTAL

Participants will receive 1-2 blood products transfused in the home each week for a total of 5 transfusions. Participants with known RBC antibodies will only be eligible to receive platelet transfusions at home. Research nurse comes to home early to draw CBC and Type and Screen. Infusion nurse delivers blood products to home. Blood product administered. Assess vital signs following administration of blood products. Perform feasibility, acceptability, appropriateness questionnaires. Complete qualitative semi-structured interviews.

Procedure: Home Blood Transfusion

Interventions

Home Blood Transfusion PROCEDURE

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

Experimental - Home Blood Transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (23)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Benson K, Popovsky MA, Hines D, Hume H, Oberman HA, Glassman AB, Pisciotto PT, Thurer RL, Stehling L, Anderson KC. Nationwide survey of home transfusion practices. Transfusion. 1998 Jan;38(1):90-6. doi: 10.1046/j.1537-2995.1998.38198141505.x.

  PMID: 9482401 BACKGROUND

• de Swart L, Smith A, Johnston TW, Haase D, Droste J, Fenaux P, Symeonidis A, Sanz G, Hellstrom-Lindberg E, Cermak J, Germing U, Stauder R, Georgescu O, MacKenzie M, Malcovati L, Holm MS, Almeida AM, Madry K, Slama B, Guerci-Bresler A, Sanhes L, Beyne-Rauzy O, Luno E, Bowen D, de Witte T. Validation of the revised international prognostic scoring system (IPSS-R) in patients with lower-risk myelodysplastic syndromes: a report from the prospective European LeukaemiaNet MDS (EUMDS) registry. Br J Haematol. 2015 Aug;170(3):372-83. doi: 10.1111/bjh.13450. Epub 2015 Apr 24.

  PMID: 25907546 BACKGROUND

• Cannas G, Fattoum J, Raba M, Dolange H, Barday G, Francois M, Elhamri M, Salles G, Thomas X. Transfusion dependency at diagnosis and transfusion intensity during initial chemotherapy are associated with poorer outcomes in adult acute myeloid leukemia. Ann Hematol. 2015 Nov;94(11):1797-806. doi: 10.1007/s00277-015-2456-2. Epub 2015 Jul 23.

  PMID: 26202609 BACKGROUND

• Jiang C, Yabroff KR, Deng L, Wang Q, Perimbeti S, Shapiro CL, Han X. Self-reported Transportation Barriers to Health Care Among US Cancer Survivors. JAMA Oncol. 2022 May 1;8(5):775-778. doi: 10.1001/jamaoncol.2022.0143.

  PMID: 35323841 BACKGROUND

• Doshi R, Gonzalez KM, Hossain A, Gentsch AT, Vivero A, Wilde L, Rising KL, Binder AF. MD Perceptions of a home blood transfusion program among patients with hematologic malignancies who are newly diagnosed as compared to those with relapsed/refractory disease American Society of Hematology Conference 2023

  BACKGROUND

• Andersen SK, Croxford R, Earle CC, Singh S, Cheung MC. Days at Home in the Last 6 Months of Life: A Patient-Determined Quality Indicator for Cancer Care. J Oncol Pract. 2019 Apr;15(4):e308-e315. doi: 10.1200/JOP.18.00338. Epub 2019 Mar 8.

  PMID: 30849006 BACKGROUND

• Banerjee R, George M, Gupta A. Maximizing Home Time for Persons With Cancer. JCO Oncol Pract. 2021 Sep;17(9):513-516. doi: 10.1200/OP.20.01071. Epub 2021 Mar 4. No abstract available.

  PMID: 33661703 BACKGROUND

• Saleem R, MacDougall K, Hassan A, et al. Novel Home-Based Transfusion Model of Palliative Care in Malignant Hematology. Blood (2022) 140 (Supplement 1): 11024- 11025.

  BACKGROUND

• Craig JI, Milligan P, Cairns J, McClelland DB, Parker AC. Nurse practitioner support for transfusion in patients with haematological disorders in hospital and at home. Transfus Med. 1999 Mar;9(1):31-6. doi: 10.1046/j.1365-3148.1999.009001031.x.

  PMID: 10216903 BACKGROUND

• Barki-Harrington L, Baron-Epel O, Shaulov A, Akria L, Barshay Y, Dally N, Deshet D, Inbar T, Koren-Michowitz M, Leiba M, Moshe Y, Shvidel L, Tadmor T, Yagenah S, Zektser M, Preis M, Hellman I, Yahalom V, Aviv A. Willingness and concerns of transfusion-dependent hematological patients toward the option of home transfusion therapy. Palliat Med. 2021 May;35(5):927-932. doi: 10.1177/02692163211000634. Epub 2021 Mar 24.

  PMID: 33761783 BACKGROUND

• Athilingam P, D'aoust R, Zambroski C, et al. Predictive Validity of NYHA and ACC/AHA Classifications of Physical and Cognitive Functioning in Heart Failure, International Journal of Nursing Science, Vol. 3 No. 1, 2013, pp. 22-32. doi: 10.5923/j.nursing.20130301.04.

  BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 BACKGROUND

• Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.

  PMID: 15883903 BACKGROUND

• Yao R, Zhang W, Evans R, Cao G, Rui T, Shen L. Inequities in Health Care Services Caused by the Adoption of Digital Health Technologies: Scoping Review. J Med Internet Res. 2022 Mar 21;24(3):e34144. doi: 10.2196/34144.

  PMID: 35311682 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type

Study Officials

• Adam Binder, MD

  Adam.Binder@jefferson.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Binder, MD

CONTACT

215-955-8874; Adam.Binder@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 13, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)