A validation study of the in vitro performance of hypoxic red blood cells for transfusion across centers in Europe

Background: Refrigerated storage of red cell concentrate (RCC) leads to metabolic, oxidative, and structural changes that impair functionality and viability. These changes can be attenuated by hypoxic storage. Objective: This study assessed the quality of leucocytes-reduced (LR), O2/CO2 reduced red blood cells (RBC) stored for 42 days after pre-storage O2/CO2 reduction with the Hemanext ONE System, to verify compliance with regional and blood center acceptance criteria across six sites. Study design and methods: Validation studies of the in vitro performance of the LR, O2/CO2 reduced storage (Hemanext ONE) System were planned and executed at blood production centers in Italy, Germany, Norway and Switzerland. The endpoint-associated study acceptance criteria included total hematocrit >50%, total hemoglobin ≥40 g and hemolysis <0.8%. Results: In total, 133 whole blood units donated at six blood centers were evaluated after processing with the Hemanext ONE System and after 21 and 42 days of storage. At Day 1 post-processing, total hemoglobin (mean ± SD) was 52.4 g/unit ± 3.1 and total hematocrit percentage (mean ± SD) was 60.6% ± 7.0 (range, 51.9%-81.0%). Hemolysis at Day 42 of storage: overall mean ± SD, 0.26% ± 0.14. Discussion: Hypoxic RBCs met regulatory quality criteria regardless of collection and processing modalities. These results indicate that processing of RBCs stored under hypoxic conditions satisfies acceptance criteria for transfusion into patients in six European regional blood centers.