Home Blood Transfusions for Anemia

Overseen By Adam Binder, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Heart failure, Solid tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the practicality and acceptability of administering blood transfusions at home for individuals with certain blood cancers or bone marrow issues who frequently require transfusions. Participants will receive blood products delivered and administered in their homes, and the study will gather feedback on the process's effectiveness and participants' experiences. The trial seeks individuals who have had two or more blood transfusions in the past month, receive cancer care at SKCCC, live within 30 miles of the center, and have no history of transfusion reactions. As an unphased trial, this study offers participants the chance to contribute to innovative care solutions that could enhance quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that home blood transfusions are safe?

Research has shown that home blood transfusions are generally safe and well-tolerated. In one study, out of 11,928 home transfusions, only 144 cases (1.21%) experienced mild side effects, and just 6 cases (0.05%) had severe reactions, indicating that serious problems are very rare.

Another study found that home-based blood transfusions are safe, particularly for carefully selected patients. Although existing studies aren't perfect, they provide some reassurance about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional anemia treatments that require visits to a hospital or clinic for blood transfusions, home blood transfusions offer the convenience of receiving care right at home. This approach not only saves time and reduces the stress of travel for patients but also provides a more comfortable and personalized healthcare experience. Researchers are excited about the potential for home transfusions to maintain patient safety while improving access to essential treatments, especially for individuals with mobility issues or those living in remote areas.

What evidence suggests that home blood transfusion is effective for anemia?

Research has shown that home blood transfusions, which participants in this trial will receive, are generally safe. A review found only a 0.05% chance of serious side effects. Another study found that many patients with blood cancers experienced noticeable symptom relief after receiving transfusions at home. Specifically, 68% of these patients showed improved lab results and overall health. Although home transfusions have not been directly compared to hospital ones for effectiveness, the symptom improvement is encouraging. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with blood-related cancers or bone marrow failure syndromes who need regular blood transfusions. Participants should be interested in receiving these transfusions at home and able to complete surveys and interviews about the experience.

Inclusion Criteria

Provide signed and dated informed consent form

Must be willing to allow people into the home

Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria

Are incarcerated

I have difficulty with IV access.

Patients who have a history of a transfusion reaction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1-2 blood products transfused in the home each week for a total of 5 transfusions

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home Blood Transfusion

Trial Overview The study is testing the feasibility of a home blood transfusion program, where enrolled patients receive 1-5 units of blood products at their residence. The research will gather data on any challenges faced during administration.

How Is the Trial Designed?

Group I: Experimental - Home Blood Transfusion Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9796283/

Home‐based blood transfusion therapy: A systematic review Overall incidence of severe adverse events was 0.05%. No studies evaluated the effectiveness of home versus hospital transfusions.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425008383

Effectiveness and Safety of Home-Based RBC ... Results. Seventy-seven patients (58 HM, 19 ST) received 1,664 units of RBCs. Symptom improvement was significantly greater in HM patients ...

3. ashpublications.org ashpublications.org/blood/article/142/9/777/486955/How-I-treat-anemia-with-red-blood-cell-transfusion

How I treat anemia with red blood cell transfusion and iron Analyses across all patients in these randomized trials indicate that restrictive transfusion thresholds ∼7 to 8 g/dL are as safe and effective as the 9 to 10 g ...

4. aob.amegroups.org aob.amegroups.org/article/view/10637/html

End-of-life blood transfusion can improve quality of life studied that among patients receiving home-transfusions, 68% had post-transfusion improvement in terms of lab values and patient outcome (41).

5. hopkinsmedicine.org hopkinsmedicine.org/news/newsroom/news-releases/2024/07/study-suggests-preoperative-iron-infusions-work-better-than-blood-transfusions-for-some-anemic-patients

Study Suggests Preoperative Iron Infusions Work Better ... Johns Hopkins Medicine researchers conclude that some patients with preoperative anemia have better outcomes if they get iron infusions before surgery.

6. probiologists.com probiologists.com/article/a-commentary-on-patient-and-caregiver-perceptions-of-home-blood-transfusions-in-the-united-states

Journal of Clinical and Experimental Hematology Based on these data, home transfusions appear to be safe, with only 144 (1.21%) mild adverse reactions and 6 (0.05%) severe adverse reactions out of 11,928 home ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06487247

NCT06487247 | HEME Home Transfusion Program Refractory anemia and thrombocytopenia are common for patients with blood cancers and result in debilitating fatigue, shortness of breath, and bleeding.

8. aob.amegroups.org aob.amegroups.org/article/view/11039/html

Impact of red blood cell transfusion on patient's quality of life In conclusion, RBC transfusion therapy plays a crucial role in improving QoL outcomes in patients with thalassemia and SCD by ameliorating ...