(P-BB-31) Donors on Testosterone Replacement Therapy have Elevated Testosterone Concentrations in Plasma and can be Mitigated with Pathogen Reduction Technology

Background/Case Studies: Donors on testosterone replacement therapy (TRT) may require frequent whole blood donation due to erythrocytosis. However, FDA guidelines prevent the use of plasma-based products secondary to possible increased testosterone concentrations. Although TRT donors may have supraphysiologic testosterone concentrations, the steroid can be easily removed with some charcoal formulations. The aim of this study was to compare red blood cell (RBC) component and plasma testosterone concentrations in TRT donors and use an FDA-approved pathogen reduction technology (PRT) with a compound adsorption device comprised of charcoal to evaluate any changes in testosterone levels.

Study

Design/Methods: Male TRT donors (n=40) and controls matched for age and sex (n=25) were selected during the donation process. Leukoreduced whole blood collected in CPDA1 was processed into RBC and plasma components. Less than one-day old RBC component supernatants and plasma samples were dialyzed and analyzed by liquid chromatography tandem mass spectrometry to measure free and total (free and bound to carrier proteins) testosterone. Plasma components with supraphysiologic levels were selected for pathogen reduction (INTERCEPT® Blood System) using the process for platelets to replicate platelet pathogen reduction in an acellular manner. PRT was performed on two-unit pools to meet guard band volume requirements. Statistical significance was evaluated with a nonparametric, two-tailed t-test (unpaired).

Results/Findings: TRT donors had significantly higher free and total testosterone in all components compared with controls (Table 1). The RBC supernatant and plasma measurements were not significantly different from one another (p=0.99). Supraphysiologic free testosterone in plasma was observed in 15 (38%) TRT donors compared with 2 control donors (8%). After receipt of the results, a follow-up interview of the two healthy donors revealed administration of other anabolic steroids used to raise testosterone that were not disclosed during the donation process. Eight donors with similar values were paired to make four PRT treated units. The mean plasma free testosterone decreased from 372.33 pre-treatment to 100.35 pg/mL post-treatment and the mean total testosterone decreased from 1165.88 to 375.13 ng/mL. Units with higher testosterone values resulted in a greater percentage of removal.

Conclusions: RBC components without additive solution have comparable testosterone concentrations as plasma components. TRT donors were significantly higher than the controls and above the established reference range. Direct questions about TRT during the interview process failed to identify two donors on other testosterone-elevating compounds. The use of an approved pathogen reduction system using charcoal removed at least 25% of the free testosterone and 30% of the protein-bound testosterone and may represent a viable method to use plasma from TRT donors.

Importance of research: Donors on testosterone are optimal whole blood donors since they may qualify for more frequent donations. However, their plasma cannot be used as a transfusable product given the possible high concentrations of testosterone. We evaluated the testosterone levels in donors on testosterone replacement therapy and showed that the elevated concentrations can be mitigated with pathogen reduction technology.