Elevated plasma testosterone concentrations from males on testosterone replacement therapy are mitigated with pathogen reduction technology.

Background: Donors on testosterone replacement therapy (TRT) may require frequent whole blood donation due to erythrocytosis, but FDA guidelines prevent the transfusion of plasma-based products from these donors. This study surveyed TRT donor testosterone levels in whole blood components and evaluated a possible mitigation strategy with a pathogen reduction technology using UVA light and compound adsorption device (CAD) steps.

Study design and methods: Whole blood from male TRT donors and controls were processed into red blood cells and plasma components. Free and total testosterone were measured in 78 TRT donors and 48 controls by high-performance liquid chromatography-tandem mass spectrometry. Pathogen reduction (INTERCEPT Blood System) on pooled plasma components (n = 10) with supraphysiologic testosterone were sampled: before treatment, after UVA illumination, and after CAD incubation.

Results: TRT donors had 3.8 and 3.9 times more free testosterone in plasma and red blood cell supernatant, respectively, and 2.3 times more total testosterone in both components than controls (p < .0001). Two controls and 33 TRT donors had supraphysiologic testosterone. The CAD incubation reduced the mean free and total testosterone by 88% (571.72-73.8 pg/mL) and 84% (1498.61-240.59 ng/mL), respectively (p = .0065), but UVA light had no effect (p > .9999).

Discussion: TRT donors had significantly higher testosterone levels than controls. The CAD step in the pathogen reduction process abrogated supraphysiologic testosterone in plasma at or below the reference range. Studies validating testosterone removal from plasma can support the transfusion of pathogen-reduced plasma and platelets from TRT donors.