Pathogen Reduction of Fresh Whole Blood for Military and Civilian Use.

摘要

Hemorrhage resulting from combat-related injuries is the most common cause of potentially preventable deaths in military operations. Evidence indicates that the use of fresh whole blood (FWB) during massive transfusion (>10 units) is independently associated with improved survival. The use of warm FWB currently persists only in emergency life-threatening scenarios when tested, stored blood components are not available, such as combat casualties. Risks of non-leukoreduced FWB transfusions include the transmission of infectious agents due to prior exposures or exposures in theater, alloimmunization to donor antigens and the potential for microchimerism. These risks may be mitigated in large part by a process capable of pathogen reduction and leukocyte inactivation. Such a technique, Pathogen Reduction Technology (PRT), can increase the safety of FWB and provide both an adequate and safe blood supply in a combat environment. This presentation will review work in progress on the development of such a system to treat fresh whole blood, which is capable of reducing infectious pathogen loads of bacteria, viruses, and parasites and inactivating white blood cells. This process is based on the use of riboflavin (vitamin B2) and UV light and relies on a photochemical process capable of disrupting nucleic acid replication processes in pathogens and white cells. Pre-clinical evaluations of device performance include tests of blood component quality, as well as tests of WBC inactivation, of virus reduction, and of bacteria reduction. The device is currently in clinical evaluation in the United States under an FDA approved Investigational Device Exemption. Early results with this system from pre-clinical and clinical studies will be provided. This work is supported through grants provided by the US Department of Defense.