Home Blood Transfusions

Thomas Jefferson University

Status: Enrolling

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

Treatments: Procedure: Home Blood Transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07121140

iRISID-2024-1731

JT 44575 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental - Home Blood Transfusion

Experimental group

Description:

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.

Treatment:

Procedure: Home Blood Transfusion