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

Male TRT donors had significantly higher free testosterone concentrations in plasma and red blood cell supernatant compared to controls.

• TRT donors had 3.8 times more free testosterone in plasma than controls (p < .0001).
• TRT donors had 3.9 times more free testosterone in red blood cell supernatant than controls (p < .0001).
• 78 TRT donors and 48 controls were measured by high-performance liquid chromatography-tandem mass spectrometry.
• Whole blood from male TRT donors and controls were processed into red blood cells and plasma components.

Male TRT donors had significantly higher total testosterone concentrations in both plasma and red blood cell supernatant compared to controls.

• TRT donors had 2.3 times more total testosterone in both plasma and red blood cell supernatant than controls (p < .0001).
• Sample sizes were 78 TRT donors and 48 controls.
• Measurements were conducted using high-performance liquid chromatography-tandem mass spectrometry.

A substantial proportion of TRT donors had supraphysiologic testosterone levels, compared to very few controls.

• 33 TRT donors had supraphysiologic testosterone levels.
• Only 2 controls had supraphysiologic testosterone levels.
• Total sample included 78 TRT donors and 48 controls.

The CAD incubation step in the INTERCEPT Blood System pathogen reduction process significantly reduced both free and total testosterone in pooled plasma with supraphysiologic testosterone.

• CAD incubation reduced mean free testosterone by 88%, from 571.72 to 73.8 pg/mL (p = .0065).
• CAD incubation reduced mean total testosterone by 84%, from 1498.61 to 240.59 ng/mL (p = .0065).
• Pathogen reduction was performed on pooled plasma components (n = 10) with supraphysiologic testosterone.
• Samples were collected before treatment, after UVA illumination, and after CAD incubation.
• The CAD step reduced testosterone to at or below the reference range.

UVA light illumination in the INTERCEPT Blood System pathogen reduction process had no effect on testosterone concentrations.

• UVA light had no statistically significant effect on testosterone levels (p > .9999).
• Samples were collected before treatment and after UVA illumination as part of the pathogen reduction process.
• The absence of effect from UVA light indicates that testosterone reduction was attributable solely to the CAD incubation step.

FDA guidelines currently prevent the transfusion of plasma-based products from TRT donors, but pathogen reduction technology may provide a mitigation strategy.

• TRT donors may require frequent whole blood donation due to erythrocytosis.
• The authors suggest that studies validating testosterone removal from plasma can support the transfusion of pathogen-reduced plasma and platelets from TRT donors.
• The INTERCEPT Blood System uses UVA light and a compound adsorption device (CAD) step.