The pathogen-reduced red blood cell suspension: single centre study of clinical safety and efficacy in children with oncological and haematological diseases.

BACKGROUND: Transmission of pathogens through blood transfusion is still of great concern to clinicians, patients and blood providers. Pathogen reduction technologies (PRT) have been successfully applied for the treatment of labile blood components, such as plasma, platelets and whole blood (WB), which are now used in routine in many countries. We report the clinical evaluation of suspension of red blood cells (RBC-S) derived from the WB treated with riboflavin and UV light (RF+UV). STUDY DESIGN AND METHODS: Seventy paediatric patients (0·3-17·1 years old) suffering from different malignant disorders were recruited and assigned to two groups: the control group (C) received transfusions of γ-irradiated RBC-S. The experimental group (T) received RBC-S derived from WB, treated with RF+UV. Clinical efficacy was evaluated during follow-up periods by Hb and Ht increments, and needs for transfusion support. Safety was assessed through active surveillance, recording post-transfusion reactions, anti-erythrocyte's antibody formation, haptoglobin and serum potassium levels. RESULTS: The clinical efficacy of RBC-S in both groups was similar: mean post-transfusion Hb concentration (101·6 ± 7·57 g/l vs. 100 ± 8·3 g/l; P = 0·43), and Ht level (28·5 ± 2·42% vs. 28·2 ± 2·7%; P = 0·66). Transfusion of pathogen-reduced RBC-S did not increase the frequency of transfusion reactions and did not induce an excessive immune response in the follow-up period. CONCLUSION: Transfusion of RBC-S, obtained from pathogen-reduced WB, is a promising method to increase the safety of blood component therapy for paediatric patients with malignant disorders without affecting clinical efficacy. A randomized clinical trial including more patients should follow this pilot study to confirm its results.