This pilot study aims to gather preliminary evidence on how different hemoglobin levels impact blood biomarkers related to bleeding. The feasibility of conducting a future larger clinical trial will also be assessed. Red blood cell transfusions are part of the standard of care for patients with leukemia. This study evaluates two transfusion strategies: one that maintains hemoglobin levels above the standard-of-care threshold, reflecting current routine practice; and another that maintains hemoglobin levels above 110 g/L, which is closer to the normal hemoglobin range. The normal hemoglobin range is 120-160 g/L for females and 140-180 g/L for males. Raising hemoglobin levels closer to normal values may reduce bleeding risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.
Juravinski Hospital
Hamilton, Ontario, Canada
RECRUITINGEffect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers.
Blood and urine samples will be taken from participants at selected timepoints to measure levels of biomarkers from the endothelial integrity, inflammation, and fibrinolysis/coagulation domains.
Time frame: Samples will be collected before chemotherapy onset, and on days 7, 14, and 28. The first day of chemotherapy is considered day 1
Protocol adherence to the study intervention (feasibility outcome)
The total number of days where hemoglobin levels were above the assigned threshold or days where RBCs were administered when the hemoglobin level was reported to be below that threshold.
Time frame: Day 1 to 30
Protocol adherence to the study schedule (feasibility outcome)
Measurement of how consistently participants and study staff follow the prescribed schedule for study assessments and sample collections as outlined in the study protocol. Measurements include percentage of scheduled biomarker testing days with data collected, percentage of non-weekday study days with completed bleeding assessments, and percentage of scheduled study days with completed FACT questionnaires.
Time frame: Day 1 to 30
Consent rate (feasibility outcome)
The proportion of potential participants who agree to participate in the study.
Time frame: Through study completion, an average of 1.5 years
Screen failure rate (feasibility outcome)
The proportion of participants who are screened for eligibility but do not meet the study's inclusion and exclusion criteria and are therefore not enrolled in the trial.
Time frame: Through study completion, an average of 1.5 years
The total number of blood products administered to participants in the liberal and standard arms of the study
The number of platelet and red blood cell units administered to each participant will be summed and compared between study groups.
Time frame: Day 1 to 30
The association between the hemoglobin threshold used and bleeding events
Comparison of the time-to-bleed data between the study groups.
Time frame: Day 1 to 30
The association between the hemoglobin threshold used and quality-of-life
The FACIT-Thrombocytopenia scale will be used to score participants between 0 (worst quality of life) and 52 (best quality of life). Higher scores indicate better quality of life, and less impact of symptoms related to thrombocytopenia.
Time frame: Assessed weekly, from before chemotherapy onset to day 28
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