Home Transfusion for HEME

Hematologic Malignancy Clinical Trial

Official title:

A Home Transfusion Program for Patients With Advanced Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509439
• Other study ID #: 22-178
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Dana-Farber Cancer Institute
• Contact: Oreofe O. Odejide, MD,MPH
• Phone: (617) 632-6864
• Email: Oreofe_Odejide[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate	Number of patients consented to the study divided by eligible patients approached by the study team	6 months
Primary	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	Satisfaction Rate	Proportion of enrolled patients who are satisfied with the home transfusion program and proportion of enrolled patients who are likely to recommend the home transfusion program.	3 Weeks
Secondary	Disenrollment Rate	Proportion of study participants who disenroll from the study.	6 months