Home Blood Transfusions

NCT ID: NCT07121140

Last Updated: 2025-12-16

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematologic Malignancy Myelodysplastic Syndromes Acute Myeloid Leukemia Transfusion Dependent Cytopenias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental - Home Blood Transfusion

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.

Group Type EXPERIMENTAL

Home Blood Transfusion

Intervention Type PROCEDURE

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

Interventions

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Home Blood Transfusion

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Binder, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Binder, MD

Role: CONTACT

215-955-8874

Facility Contacts

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Adam Binder, MD

Role: primary

215-955-8874

References

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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.

Reference Type BACKGROUND
PMID: 9482401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3049774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35686926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30229938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22336393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30268597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29848484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32359453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7740619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25907546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26202609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35323841 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 30849006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33661703 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 10216903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33761783 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16204405 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15883903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35311682 (View on PubMed)

Other Identifiers

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JT 44575

Identifier Type: OTHER

Identifier Source: secondary_id

iRISID-2024-1731

Identifier Type: -

Identifier Source: org_study_id