Home Blood Transfusions

December 8, 2025 updated by: Thomas Jefferson University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Home Blood Transfusion
Participants will be provided with transfusion of blood products, specifically red blood cells and platelets, in the home setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of a home blood transfusion program utilizing the RE-AIM framework
Time Frame: 5 weeks
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
Time Frame: 5 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate patient perspective of home blood transfusions via qualitative analysis.
Time Frame: Within 3 weeks of final home transfusion
Evaluate patient perspective of home blood transfusions via qualitative analysis. Semi-structured interviews will be evaluated through qualitative analysis. All interviews will be digitally recorded and transcribed. Interviews will be analyzed using NVIVO software for coding and analysis. The codebook will be developed using conventional content analysis. All members of the research team will read the first three transcripts and identify concepts, leading to the initial code structure. This initial code structure will be applied to subsequent interviews by two coders and refined to include new themes as they emerge. This iterative process will continue until coders and at least one other team member agree upon a final coding structure, with discrepancies resolved through consensus. The two coders will apply the final structure to all transcripts. Coders will double code about 30-40% of the transcripts. Intercoder reliability will be calculated in NVivo 12 using the κ coefficient.
Within 3 weeks of final home transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Adam Binder, MD, Adam.Binder@jefferson.edu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

July 30, 2025

First Submitted That Met QC Criteria

August 12, 2025

First Posted (Actual)

August 13, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iRISID-2024-1731
  • JT 44575 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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