Pilot Study on Blood Biomarkers in Acute Leukemia Patients with Anemia-Induced Bleeding Comparing Two Red Blood Cell Transfusion Strategies to Maintain Different Hemoglobin Levels

What this Trial Is About

This research aims to understand how different hemoglobin levels affect blood markers related to bleeding in patients with acute leukemia. It evaluates two red blood cell transfusion strategies one maintaining hemoglobin above the standard threshold used in routine care, and another targeting a higher level closer to normal hemoglobin values. The study also explores the feasibility of running a larger clinical trial in the future to further investigate these effects. Participants will be randomly assigned to one of two groups. One group will receive transfusions to keep their hemoglobin level at least 110 gL, while the other group will follow the standard care transfusion strategy, maintaining hemoglobin at about 70-80 gL. These strategies will be carried out during the first month after the start of induction chemotherapy, with blood samples taken before chemotherapy and on days 7, 14, and 28 to study bleeding-related biomarkers. During the study, participants will be closely monitored for adherence to the transfusion protocol and schedule over 30 days. Researchers will collect blood samples and measure bleeding risk markers, the number of transfusions given, bleeding events, and quality of life weekly from before chemotherapy through day 28. Consent rates and screen failure rates will also be tracked over an average of 1.5 years to assess how feasible the study design is for future trials.

Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding