Study Comparing Safety and Effectiveness of Hypoxic RBCs Made with Hemanext ONE System versus Conventional RBCs in Adults with Blood Cancers Needing Regular Transfusions

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of transfusing hypoxically stored red blood cells RBCs processed using the Hemanext ONE device in patients with hematological malignancies who require chronic blood transfusions. The study aims to determine if the number of hypoxic RBC units transfused over time is not inferior to that of conventional RBC units. Secondary goals include assessing blood volume transfused, transfusion frequency, blood lab values, quality of life, serum ferritin levels, and safety. Participants will receive transfusions of either hypoxic RBCs processed by the Hemanext ONE system or conventional RBCs in a randomized, controlled cross-over design. The study compares these two types of blood products delivered over an average period of 15 months. The Hemanext ONE device has received CE mark approval, and this study evaluates its performance specifically in transfusion-dependent patients with hematologic cancers. Throughout the study, participants will have regular monitoring of transfusion events, blood volume transfused, hemoglobin and hematocrit measurements after transfusions, quality of life assessments, and serum ferritin levels at set time points including 6 and 15 months. Safety is evaluated by tracking adverse reactions and device issues. The total participation duration averages 15 months, during which detailed laboratory and clinical assessments support evaluation of the devices and patient outcomes.

Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion