INTERCEPT Platelets
Phase III/IV
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SPRINT Phase III
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McCullough J, Vesole DH, Benjamin RJ et al. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial. Blood 2004;104(5):1534-41.
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Murphy S, Snyder E, Cable R et al. Platelet dose consistency and its effect on the number of platelet transfusions for support of thrombocytopenia: an analysis of the SPRINT trial of platelets photochemically treated with amotosalen HCl and ultraviolet A light. Transfusion 2006;46(1):24-33.
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Pineda A, McCullough J, Benjamin RJ et al. Pathogen inactivation of platelets with a photochemical treatment with amotosalen HCl and ultraviolet light: process used in the SPRINT trial. Transfusion 2006;46(4):562-71.
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Snyder E, McCullough J, Slichter SJ et al. Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial. Transfusion 2005;45(12):1864-75.
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euroSPRITE Phase III
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van Rhenen D, Gulliksson H, Cazenave JP et al. Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial. Blood 2003;101(6):2426-33.
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van Rhenen DJ, Gulliksson H, Cazenave JP et al. Therapeutic efficacy of pooled buffy-coat platelet components prepared and stored with a platelet additive solution. Transfus Med 2004;14(4):289-95.
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EU Apheresis Study
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Janetzko K, Cazenave JP, Kluter H et al. Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set. Transfusion 2005;45(9):1443-52.
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7-Day Pilot Study
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Simonsen AC, Johansson PI, Conlan MG et al. Transfusion of 7-day-old amotosalen photochemically treated buffy-coat platelets to patients with thrombocytopenia: a pilot study. Transfusion 2006;46(3):424-33.
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TESSI (7-Day Platelets)
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Lozano M, Knutson F, Tardivel R et al. A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and UVA pathogen inactivation stored for 6 or 7 d prior to transfusion. British Journal of Haematology 2011 May;153(3):393-401.
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Phase I/II
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Snyder E, Raife T, Lin L et al. Recovery and life span of 111indium-radiolabeled platelets treated with pathogen inactivation with amotosalen HCl (S-59) and ultraviolet A light. Transfusion 2004;44(12):1732-40.
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Slichter SJ, Raife TJ, Davis K et al. Platelets photochemically treated with amotosalen HCl and ultraviolet A light correct prolonged bleeding times in patients with thrombocytopenia. Transfusion 2006;46(5):731-40.
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Additional Clinical Papers
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Cazenave JP, Davis K, Corash L. Design of clinical trials to evaluate the efficacy of platelet transfusion: the euroSPRITE trial for components treated with Helinx™ technology. Seminars in Hematology 2001;38,4 (S11):46-54.
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Corash L. Confounding variables and co-interventions in the design of clinical trials: real life experience. Vox Sang 2002;83 (S1):261-266.
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Corash L, Lin JS, Sherman DC et al. Determination of Acute Lung Injury After Repeated Platelet Transfusions. Blood 2011 Jan 20;117(3):1014-20.
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Davis KB, Slichter SJ, Corash L. Corrected count increment and percent platelet recovery as measures of posttransfusion platelet response: problems and a solution. Transfusion 1999;39(6):586-92.
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INTERCEPT Plasma
Phase III / IV
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de Alarcon P, Benjamin R, Dugdale M et al. Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies. Transfusion 2005;45(8):1362-72.
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Mintz PD, Bass NM, Petz LD, et al. Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease. Blood 2006;107(9):3753-60.
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Mintz PD, Neff A, MacKenzie M et al. A randomized, controlled Phase III trial of therapeutic plasma exchange with fresh-frozen plasma (FFP) prepared with amotosalen and ultraviolet A light compared to untreated FFP in thrombotic thrombocytopenic purpura. Transfusion 2006;46(10):1693-704.
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Phase I / II
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Hambleton J, Wages D, Radu-Radulescu L et al. Pharmacokinetic study of FFP photochemically treated with amotosalen (S-59) and UV light compared to FFP in healthy volunteers anticoagulated with warfarin. Transfusion 2002;42(10):1302-7.
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RBC
Phase I / II (Current Process)
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Cancelas JA, Dumont LJ, Rugg N et al. Stored Red Blood Cell Viability is Maintained after Treatment with a Second Generation S-303 Pathogen Inactivation Process. Transfusion 2011;51:11:2367-2376.
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Phase III (Original Process)
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Benjamin RJ, McCullough J, Mintz PD et al. Therapeutic efficacy and safety of red blood cells treated with a chemical process (S-303) for pathogen inactivation: a Phase III clinical trial in cardiac surgery patients. Transfusion 2005;45(11):1739-49.
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Phase I / II (Original Process)
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Rios JA, Hambleton J, Viele M et al. Viability of red cells prepared with S-303 pathogen inactivation treatment. Transfusion 2006;46(10):1778-86.
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