Background: A photochemical treatment (PCT) method to inactivate pathogens in platelet concentrates has been developed. The system uses a psoralen, amotosalen HCl, coupled with ultraviolet A (UVA) illumination.
Study design and methods: Three sequential clinical trials evaluated viability of PCT platelets prepared with a prototype device. Posttransfusion recovery and lifespan of (111)Indium-labeled autologous 5 day-old platelets in healthy subjects was assessed. In the first study, 23 subjects received transfusions of autologous PCT and/or control platelets. In a second study, 16 of these subjects received PCT platelets processed with a Compound Adsorption Device (CAD) (PCT-CAD) to reduce patient exposure to residual amotosalen. In the third study, the effect of gamma-irradiation on PCT platelets was studied. Data from control transfusions from Study A were used for paired comparisons in the latter 2 studies.
Results: Mean PCT-CAD platelet recovery for the 16 subjects with paired data was 42.5 +/- 8.7% versus 50.3 +/- 7.7% for control platelets, mean difference of 7.8% (p < 0.01). Mean lifespan for PCT-CAD platelets was 4.8 days (+/-1.3) versus 6.0 days (+/-1.2) for control platelets, mean difference of 1.3 days (p < 0.01). Platelet recovery and lifespan were similar to PCT-CAD for PCT without CAD treatment and PCT-CAD with gamma-irradiation.
Conclusion: Viability of 5 day-old PCT platelets was less than for control platelets. However, both were within ranges reported for 5 day-old platelets.