Home Transfusion for HEME

NCT05509439 | Completed DMC

• 1 other identifier: 22-178
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Hematologic Malignancy

Keywords

Hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• Enrollment Rate

  Number of patients consented to the study divided by eligible patients approached by the study team

  6 months

• Completion of Home Transfusions and Patient-Reported Data

  Proportion of completed home transfusions among enrolled patients who meet transfusion criteria, and proportion of enrolled patients who complete patient-reported data collection

  6 months

Secondary Outcomes (2)

• Satisfaction Rate

  3 Weeks

• Disenrollment Rate

  6 months

Study Arms (1)

Home Transfusion

EXPERIMENTAL

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

Other: Home Transfusion Program Components

Interventions

Home Transfusion Program Components 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

Home Transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Oreofe O Odejide, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: October 18, 2024
• Primary Completion: May 13, 2025
• Study Completion: May 21, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)