Cerus Corporation, Concord, CA, USA, California, United States
Background/Case Studies: Neonates with immature organ systems who require platelet transfusion are at risk for infection and transfusion-associated graft-versus-host disease (TA-GVHD); and many require concurrent phototherapy (PT) for jaundice. Pathogen reduction (PR) of platelet components (PC) with amotosalen-UVA is indicated to reduce transfusion infection and TA-GVHD risk, but clinical data for neonates are limited.
Study
Design/Methods: We evaluated the safety and efficacy of PRPC in premature and term neonates at the Inselspital, Bern, Switzerland by retrospective review of medical records for all premature and term neonates (0-28 days old) transfused with conventional PC (CPC) 72 months before (2005-2010) and PRPC 57 months after (2011-2015) PRPC adoption. Transfusion thresholds for premature and term non-bleeding neonates were < 50 x 10e9/L and < 30 x 10e9/L, respectively. Both cohorts were transfused with 5 mL PC/kg. PC platelet content was not measured at transfusion. Pre and post transfusion (1-4 hour) patient platelet counts were measured. CPC were stored for up to 5 days and gamma irradiated. PRPC were not gamma irradiated and were stored up to 7 days. Hospital records were audited for: gestation age, birth weight, PC use, pre and post transfusion platelet counts and increments, PT exposure, and PC transfusion-associated adverse events. P-values for treatment differences are based on Fisher’s Exact test and a 1-way ANOVA model, respectively, for categorical and continuous variables.
Results/Findings: 100 neonates received 234 PRPC and 91 received 171 CPC. Similar proportions of patients in each cohort had bleeding (central nervous system 18% vs 19%, lung 3% vs 3.3%) as an indication for transfusion. All other PC transfusions were for thrombocytopenia prophylaxis. The average gestational ages and birth weights were similar between cohorts (Table). There were no substantial differences in the numbers of PC transfusions. The proportions of neonates with PT were similar (51%) but the PRPC cohort had more PT events. Mean platelet count increments were within therapeutic ranges in both cohorts. No PC transfusion related adverse events, including TA-GVHD, with and without concurrent phototherapy, were reported for either cohort. Conclusions: The data support the efficacy and safety of PRPC in neonates who require platelet transfusion and phototherapy.
Importance of research: Neonates with immature organ systems who require platelet transfusion are at risk for infection and transfusion-associated graft-versus-host disease (TA-GVHD); and many require concurrent phototherapy (PT) for jaundice. Pathogen reduction (PR) of platelet components (PC) with amotosalen-UVA is indicated to reduce transfusion infection and TA-GVHD risk, but clinical data for neonates supported with platelet transfusion and phototherapy are limited.
