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


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 x 10(11) +/- 0.7 x 10(11) PLTs. The clinical process, which included trial-specific samples, resulted in a mean PLT loss of 0.8 x 10(11) +/- 0.6 x 10(11) PLTs per product. CAD treatment effectively reduced the amotosalen concentration from a mean of 31.9 +/- 5.3 micromol per L after illumination to a mean of 0.41 +/- 0.56 micromol 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.
Mayo Clinic, Rochester, Minnesota, USA.
Alvaro
A
Pineda
Jeffrey
J
McCullough
Richard J
RJ
Benjamin
Ritchard
R
Cable
Ronald G
RG
Strauss
Edwin
E
Burgstaler
Seth
S
Porter
Lily
L
Lin
Peyton
P
Metzel
Maureen G
MG
Conlan
D000818:Animals; D001792:Blood Platelets / Q000528:radiation effects*; D017848:Blood-Borne Pathogens / Q000302:isolation & purification*; D011564:Furocoumarins / Q000494:pharmacology; D006801:Humans; D010976:Platelet Count; D017713:Platelet Transfusion / Q000379:methods*; D010983:Plateletpheresis / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D014466:Ultraviolet Rays
D011564:Furocoumarins; C118577:amotosalen