The purpose of this proposal is to develop a pathogen reduction technology (PRT) for whole blood that can reduce the risk of infectious disease transmission and unwanted transfusion reactions. Blood transfusions are a critical component in the treatment of severely injured patients. Fractionation of whole blood into Red Blood Cells (RBCs), plasma, and platelets was developed to more efficiently treat specific deficiencies and for easier storage of the components. This resulted in a transition away from whole blood products and became the standard of transfusion therapy. Current practice guidelines by the military are to transfuse screened blood components, if available. If any of the components are not available, warm fresh whole blood (FWB) is used to supplement the unavailable component. FWB is not used during routine trauma care in the United States. However, in combat FWB is used without screening for pathogens that may transmit infectious diseases. FWB is also used without leukoreduction, resulting in the transfusion of millions of viable white blood cells into severely injured patients. In the U.S., removal of white blood cells from all blood products before transfusion is recommended by the AABB and in some countries leukoreduction is mandatory. Overall, reducing the risk of pathogen transmission and viable white blood cells in FWB is highly desirable.

CardidianBCT Biotechnologies has developed a prototype device for pathogen reduction and white blood cell inactivation in FWB. We will further develop this device into a portable device to be used in the military setting (Aim 1). We will verify the performance of this system by testing infectivity of viruses, bacteria, and parasites after treatment and by testing white blood cell inactivation in donor blood (Aim 2). After optimization of the system and verification of its performance in reducing the load of infectious agents in FWB, the system will be tested to determine its suitability for deployment in military combat casualty care settings (Aim 3). The Mirasol System for Whole Blood may resolve several of the underlying concerns associated with the use of whole blood or even separated components derived from whole blood. This has relevance in both the military setting, where logistical concerns and real-life issues may make testing and use of component therapy impractical, as well as in the civilian sector, where donor deferrals due to concerns over disease exposure and the emergence of existing or new pathogens continue to limit supplies and to stress manufacturers and providers of blood products. This device may thus introduce a new standard of care for both military and civilian surgeons and for transfusion medicine specialists seeking to support patients with major or traumatic blood loss.