Selected article for: "primary treatment and test treatment"
Author: Atreya, Chintamani; Glynn, Simone; Busch, Michael; Kleinman, Steve; Snyder, Edward; Rutter, Sara; AuBuchon, James; Flegel, Willy; Reeve, David; Devine, Dana; Cohn, Claudia; Custer, Brian; Goodrich, Raymond; Benjamin, Richard J.; Razatos, Anna; Cancelas, Jose; Wagner, Stephen; Maclean, Michelle; Gelderman, Monique; Cap, Andrew; Ness, Paul
Title: Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)
  • Document date: 2019_5_29
    • ID: 0m2ganys_60
    Snippet: A second randomized, double-blind, controlled crossover study (SPARC) performed in Italy and Turkey was completed in 81 transfusion-dependent thalassemia patients who receive regular RBC transfusions to treat anemia and suppress ineffective hematopoiesis (Table 4 ). Each patient (≥10 years old) received six cycles (two "wash-in" and four "efficacy evaluation" cycles) of test and control RBCs with the RBC dose determined by a physician blinded t.....
    Document: A second randomized, double-blind, controlled crossover study (SPARC) performed in Italy and Turkey was completed in 81 transfusion-dependent thalassemia patients who receive regular RBC transfusions to treat anemia and suppress ineffective hematopoiesis (Table 4 ). Each patient (≥10 years old) received six cycles (two "wash-in" and four "efficacy evaluation" cycles) of test and control RBCs with the RBC dose determined by a physician blinded to treatment. The primary endpoint was Hb consumption (g Hb/kg/day), a measure of iron burden. Subjects met the predetermined noninferiority margin of 15% of control for Hb consumption in both the intention to treat and perprotocol populations, receiving a mean of 12.6 test and control RBCs in the two treatment periods. Only 11 of 2006 (0.5%) RBC components were transfused off protocol to six patients. Adverse events were similarly distributed between periods, and no patients made treatment-emergent antibodies to INTERCEPT RBCs or to RBC alloantigens.

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