Safety and Efficacy of Amotosalen-Ultraviolet A Pathogen-Reduced Platelets Transfused to Neonates.

INTRODUCTION: The objective of this study was to compare the efficacy and safety of amotosalen/ultraviolet A pathogen-reduced platelet components (PRPCs) with conventional platelets for transfusion of term and preterm neonates who are vulnerable to transfusion-transmitted infections and transfusion associated graft vs. host disease. Safety and efficacy of concomitant use of PRPC and phototherapy (PT) treatment with a specific focus on a large cohort of premature neonates have not been investigated before. METHODS: In this retrospective cohort study, medical records were audited for gestational age, birth weight, number of transfusions, platelet count and transfusion increments, maximum bilirubin, PT, and transfusion-related adverse events. Term and preterm neonates were transfused with conventional PC (CPC) during a period of 72 months (2005-2010) before PRPC and during 57 months after PRPC implementation (2011-2015). Fresh frozen plasma (FFP) and red blood cells (RBCs) were used as surrogate hemostasis indicators. RESULTS: In the first cohort, 92 neonates received 180 CPC and in the second cohort 99 neonates received 225 PRPC. Similar proportions of patients in each cohort had bleeding (central nervous system 18% vs. 19%, pulmonary 3.0% vs. 3.3%). The gestational ages and birth weights were similar (33.1 vs. 33.0 weeks and 1.8 kg for both). The proportion of multiple births (twins, triplets) was significantly higher in the PRPC cohort (27 vs. 6). Neonates treated with PRPC received more concomitant PT treatments (3.8 vs. 2.4). There were no differences in PC, FFP, or RBC units transfused. Mean platelet count increments were not different (PRPC: 82.9 ± 45.1 vs. CPC: 95.9 ± 53.0). No patients had transfusion-related phototoxicity. CONCLUSION: The study demonstrated PRPC efficacy and safety for term and preterm neonates with or without concurrent PT.