Home Transfusion for HEME

NCT ID: NCT05509439

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-18
• Study Completion Date: 2025-05-21

Brief Summary

The purpose of the research is to assess the feasibility and acceptability of a home blood transfusion program for patients with hematologic malignancies who need blood transfusions

Detailed Description

This feasibility study will be used to assess the feasibility and acceptability of a hospice-embedded home transfusion program to patients with hematologic malignancies. All enrolled subjects will be patients cared for at Dana Farber Cancer Institute.

This study is a single-arm study of 10 patients with advanced hematologic malignancies who have a limited life-expectancy of six months or fewer and are hospice eligible.

10 Caregivers of enrolled patients will also be invited to participate if interested.

This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed.

Participants will be in the research study for up to six months.

It is expected that about 20 people will take part in this research study.

Conditions

Hematologic Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Home Transfusion

This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed.

• Home Transfusion Program Components
• Participants will be in the research study for up to six months

Group Type: EXPERIMENTAL

Home Transfusion Program Components

Intervention Type: OTHER

The Home Transfusion Program will include trained transfusion nurse(s) who will administer transfusions in the home setting. The transfusion nurse, who is part of the study team, will work closely with the DFCI/BWH Blood Bank and the hospice agency (Care Dimensions Inc.) that all study patients are enrolled in. The transfusion nurse will administer home transfusions using safe home transfusion practices endorsed by the AABB. The home transfusion program has 4 key aspects Initial home visit, (2) subsequent contact, (3) home transfusion assessment \& administration, (4) usual elements of hospice

Interventions

Home Transfusion Program Components

The Home Transfusion Program will include trained transfusion nurse(s) who will administer transfusions in the home setting. The transfusion nurse, who is part of the study team, will work closely with the DFCI/BWH Blood Bank and the hospice agency (Care Dimensions Inc.) that all study patients are enrolled in. The transfusion nurse will administer home transfusions using safe home transfusion practices endorsed by the AABB. The home transfusion program has 4 key aspects Initial home visit, (2) subsequent contact, (3) home transfusion assessment \& administration, (4) usual elements of hospice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with advanced hematologic malignancies:

• Diagnosis of a hematologic malignancy
• Age ≥ 18 years
• Receipt of primary oncologic care at DFCI (at least 2 outpatient visits in 12 months prior to enrollment)
• Has received at least one red blood cell (RBC) or platelet transfusion since blood cancer diagnosis in the clinic or hospital setting without a serious adverse transfusion reaction
• Physician-estimated prognosis of six months or less
• Has an adult informal caregiver that lives in the same residence
• Patient resides within catchment served by Care Dimensions Hospice
• Caregivers:

• Identified informal caregiver of enrolled patient with hematologic malignancy
• Age ≥ 18 years

Exclusion Criteria

• Patients

• Age < 18 years
• Does not have an identified adult informal caregiver who lives in the same residence
• History of previous serious adverse transfusion reaction
• Presence of decompensated congestive heart failure
• Caregiver

• Age < 18 years
• Our study will exclude members of the following special populations:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Oreofe Odejide, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oreofe O Odejide, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

22-178

Identifier Type: -

Identifier Source: org_study_id