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Pathogen inactivation of platelets with a photochemical treatment with amotosalen HCl and ultraviolet light: process used in the SPRINT trial
Author(s) -
Pineda Alvaro,
McCullough Jeffrey,
Benjamin Richard J.,
Cable Ritchard,
Strauss Ronald G.,
Burgstaler Edwin,
Porter Seth,
Lin Lily,
Metzel Peyton,
Conlan Maureen G.
Publication year - 2006
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2006.00761.x
Subject(s) - apheresis , platelet , ultraviolet , chemistry , medicine , materials science , optoelectronics
BACKGROUND: A photochemical treatment (PCT) system has been developed to inactivate a broad spectrum of pathogens and white blood cells in platelet (PLT) products. The system comprises PLT additive solution (PAS III), amotosalen HCl, a compound adsorption device (CAD), a microprocessor‐controlled ultraviolet A light source, and a commercially assembled system of interconnected plastic containers. STUDY DESIGN AND METHODS: A clinical prototype of the PCT system was used in a large, randomized, controlled, double‐blind, Phase III clinical trial (SPRINT) that compared the efficacy and safety of PCT apheresis PLTs to untreated apheresis PLTs. The ability of multiple users was assessed in a blood center setting to perform the PCT and meet target process specifications. RESULTS: Each parameter was evaluated for 2237 to 2855 PCT PLT products. PCT requirements with respect to mean PLT dose, volume, and plasma content were met. Transfused PCT PLT products contained a mean of 3.6 × 10 11 ± 0.7 × 10 11 PLTs. The clinical process, which included trial‐specific samples, resulted in a mean PLT loss of 0.8 × 10 11 ± 0.6 × 10 11 PLTs per product. CAD treatment effectively reduced the amotosalen concentration from a mean of 31.9 ± 5.3 µmol per L after illumination to a mean of 0.41 ± 0.56 µmol per L after CAD. In general, there was little variation between sites for any parameter. CONCLUSIONS: The PCT process was successfully implemented by 12 blood centers in the United States to produce PCT PLTs used in a prospective, randomized trial where therapeutic efficacy of PCT PLTs was demonstrated. Process control was achieved under blood bank operating conditions.