Indications Against Highly Pathogenic Agents for a Transportable Pathogen Reduction and Blood Safety System for Whole Blood
Abstract
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. Every year there are new pathogens that place the blood supply at risk. Pathogen reduction technology changes the paradigm from a reactive approach of testing blood for pathogens to proactively treating the blood before a pathogen enters the blood supply. 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 US, removal of white blood cells from all blood products before transfusion is recommended by the American Association of Blood Banks and in some countries leukoreduction is mandatory. Overall, reducing the risk of pathogen transmission and viable white blood cells in FWB is highly desirable. Terumo BCT Biotechnologies has developed a prototype device for pathogen reduction and white blood cell inactivation in FWB and is currently undergoing clinical trials in the US and other countries for US Food and Drug Administration approval in the near term. We will further develop this device into a portable device to be used in the military setting. We will verify the performance of this system by testing infectivity of emerging pathogens of concern (viruses, bacteria) before and after treatment. 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 increased use of whole blood for trauma has been implemented with success and 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.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jul 16, 2019
- Source ID
- W81XWH1910223
Entities
People
- Raymond P Goodrich
Organizations
- Colorado State University
- United States Army