Background and ProblemCurrent FDA regulation allows donated blood to remain in storage at 4ºC for up to 42 days before transfusion. However, during storage red blood cells (RBCs) undergo biochemical and physical changes, termed “storage lesion,” that reduce oxygen delivery to tissues and induce immunosuppression and hyperinflammation in transfusion patients.
These result, in part, from the decay of 2,3-diphosphoglycerate and alterations to multiple cytokines, respectively. Studies have shown a correlation between transfusions of older blood units with longer hospital stays as well as with higher rates of mortality, renal failure, acute lung damage, and sepsis. The problem is that while regulation requires extensive disease screening of blood units, but there is neither standing regulation nor simple and effective tests to assess sample quality.
According to medical researchers Doctor and Spinella, the sole purpose of a transfusion is to improve oxygen delivery within the body. Transfusions of older blood units will improve the oxygen content within the bloodstream of a patient, but the O2 saturation of the patient’s tissue would actually drop because the storage lesion limits delivery to the surrounding tissues. Therefore, we define a “quality” blood unit as one that will help improve oxygen delivery to the tissues of a transfusion patient.
Usage and Benefit of the SolutionIn the U.S. millions of patients are administered transfusions each year and transfusions remain an irreplaceable supplement for surgery and treatment for trauma and disease. Therefore, an analytical tool to evaluate the quality of stored blood could be utilized by hospitals and clinics around the world, potentially influencing the treatment of hundreds of millions of people per year. Hospitals would benefit because such a tool would facilitate patient turnover; reduce overnight stays; and, consequently, reduce operating costs.
If proven effective, quality screening could reduce post-transfusion observation time and perhaps transition the treatment to an outpatient procedure. This paradigm shift would translate into lower healthcare costs for the populace and faster patient recovery. Therefore, based on our research of the literature and of medical practices, we have determined there needs to be method to assess the quality of stored blood to improve transfusion patient outcomes.