Whole Blood Donation and Leukoreduction Clinical Trial
Official title:
Clinical Investigation to Evaluate the New Health Sciences Hemanext® Oxygen Reduction System for Leukoreduced Red Blood Cells With CP2D Anticoagulant and AS-3 Additive - Pivotal Trial
The primary goal of Hemanext. is to improve red cell storage through novel storage methods.
Based on our review of the pertinent literature, there is substantial evidence suggesting
that prolonged exposure to oxygen during storage results in oxidative damage to the red blood
cells leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood
cell products prior to storage has potential to preserve the cells in a more physiologically
relevant state.
Currently, Hemanext has focused on the design and development of a dual compartment bag
system designated as the Hemanext Red Blood Cell Processing System. After standard processing
of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) with the
appropriate additive solutions, the LR-RBCs would then be placed in the oxygen reduction bag
(ORB) which allows for the rapid diffusion of oxygen out of the blood, through a sterile,
oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood
is transferred again from the ORB into the Hemanext storage bag (HSB) which will preserve the
anaerobic state of the LR-RBC product for the duration of cold storage.
Hemanext has conducted preliminary storage tests to ascertain the effects of anaerobic
storage on overall blood health in various storage solutions. The research team has focused
primarily on percent hemolysis, which is mandated by the FDA to remain below 1% for the
duration of storage, as well as ATP and 2,3-DPG levels.
In vitro and in vivo performance of O2/CO2 reduced red blood cells produced with the Hemanext System will be used to demonstrate the acceptability the final product for clearance. To accomplish this, the study will require a total of 100 studyevaluable donors. completing the study. The study entails a randomized, paired, 2-x-2 crossover design where every study donor (n = 10093) evaluable study donors who completes the study will donate a total of two whole blood units with individual units being donated at least 56 days (8 weeks) apart. One unit will be used as the test and the other unit will be used for the control. The order in which the IP and the CP will be used to collect, filter and store the whole blood and appropriate blood products (within the context of the crossover design) will be randomized. ;