Pathogen inactivation of platelets with a photochemical treatment with amotosalen HCl and ultraviolet light: Process used in the SPRINT trial

Alvaro Pineda, Jeffrey McCullough, Richard J. Benjamin, Ritchard Cable, Ronald G. Strauss, Edwin Burgstaler, Seth Porter, Lily Lin, Peyton Metzel, Maureen G. Conlan

Research output: Contribution to journalArticlepeer-review

20 Scopus citations

Abstract

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 × 1011 ± 0.7 × 1011 PLTs. The clinical process, which included trial-specific samples, resulted in a mean PLT loss of 0.8 × 10 11 ± 0.6 × 1011 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.

Original languageEnglish (US)
Pages (from-to)562-571
Number of pages10
JournalTransfusion
Volume46
Issue number4
DOIs
StatePublished - Apr 1 2006

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