Actively Recruiting
Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life, and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study
Led by University of Washington · Updated on 2026-02-12
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how different hemoglobin levels for packed red blood cell (PRBC) transfusions affect quality of life and function in patients treated for high-grade myeloid neoplasms, acute myeloid leukemia, or B acute lymphoblastic lymphoma/leukemia. These conditions often require chemotherapy or stem cell transplants that can cause anemia and low platelet counts, leading to the need for PRBC transfusions. The trial aims to balance transfusion safety and risks while considering blood supply shortages by comparing two hemoglobin thresholds. Participants are randomly assigned to one of two groups: one group receives PRBC transfusions when hemoglobin drops to 7 gm/dL or less, and the other group receives transfusions when hemoglobin is 9 gm/dL or less. Transfusions start the day after standard chemotherapy or stem cell transplant completion and continue for up to 42 days. Blood samples are collected during the study. After treatment, patients are followed for 7 days and then monitored periodically for up to 5 years. During the trial, participants undergo assessments including blood sample collections and quality-of-life and cognitive evaluations. Researchers track how well patients tolerate the transfusion thresholds, collect data on safety, and measure quality of life and function. The main outcomes are the percentage of patients who consent and tolerate the assigned transfusion threshold and safety analyses over up to 30 months. The study is sponsored by the University of Washington and involves long-term follow-up to evaluate lasting effects.
CONDITIONS
Brief Title
Evaluating the Effects of Hemoglobin Threshold-specific Packed Red Blood Cell Transfusions on Quality of Life and Functional Outcomes in Patients With High-grade Myeloid Neoplasms, Acute Myeloid Leukemia, or B Acute Lymphoblastic Lymphoma/Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of high-grade myeloid neoplasm (≥ 10% blasts in blood or bone marrow), acute myeloid leukemia (excluding acute promyelocytic leukemia), or B-cell acute lymphoblastic lymphoma/leukemia
- Planned intensive chemotherapy induction or post-remission therapy, or allogeneic hematopoietic stem cell transplant expected to cause anemia requiring packed red blood cell transfusion and platelet counts ≤ 30,000/uL for at least 5 days after therapy
- Plan to receive all post-chemotherapy or post-transplant care at University of Washington or Fred Hutchinson Cancer Center
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Need for prophylactic platelet transfusion at thresholds > 10,000/uL
- Need for systemic anticoagulation, anti-platelet, or antifibrinolytic therapy that cannot be stopped once platelets are below 50,000/uL
- Grade 2 or higher bleeding at time of randomization
- Recent arterial or venous thrombotic event, including myocardial infarction within 6 months before chemotherapy or transplant
- Requirement for renal replacement therapy at randomization
- Decline of transfusion for personal or religious reasons
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 42 days
Participants receive packed red blood cell transfusions starting the day after their standard chemotherapy or stem cell infusion is complete, depending on their assigned hemoglobin threshold. Blood samples are collected during this period.
Regular transfusions and blood sample collections during treatment
Duration - Up to 5 years
Participants are followed for 7 days after treatment completion and then periodically for up to 5 years to assess long-term outcomes.
Periodic visits over several years
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
A
Anna Halpern, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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