Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Location status: Recruiting
NCT Number: NCT06710418
This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma/leukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and/or anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the "minimum" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (> 7 gm/dL) compared to a more liberal hemoglobin threshold (> 9 gm/dL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98109, United States
Location status: Recruiting
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo PRBC transfusion if at any point their hemoglobin level is 7 gm/dL or less, starting the day after standard of care (SOC) chemotherapy/stem cell infusion is complete and continuing for up to 42 days. Patients also undergo collection of blood samples on study.
ARM II: Patients undergo PRBC transfusion if at any point their hemoglobin level is 9 gm/dL or less, starting the day after SOC chemotherapy/stem cell infusion is complete and continuing for up to 42 days. Patients also undergo collection of blood samples on study.
After completion of study intervention, patients are followed up for 7 days and then periodically for up to 5 years.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ancillary studies
Undergo blood sample collection
Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Ancillary studies
Ancillary studies
Undergo PRBC transfusion
Other names: PRBC Transfusion
Ancillary studies
Other names: Quality of Life Assessment
Time frame: Up to 30 months
Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 50% of eligible patients consent.
Time frame: Up to 7 days after completion of study intervention
Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 75% of the patients randomized to the restrictive 7 gm/dL threshold tolerate this transfusion trigger. A patient will be defined as tolerant if the patient receives transfusions at a hemoglobin threshold higher than > 7gm/dL less than 3 times due to signs/symptoms of acute anemia.
Time frame: Up to 30 months
Randomizing patients to two different transfusion thresholds will be considered feasible if there is no indication for early termination based on the interim safety analyses.
Contact information is provided by the study sponsor or research team.
University of Washington
Other
Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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