Investigation of a new in-line leukocyte reduction filter for packed red blood cells

摘要

Background and objectives: Occasionally there are adverse transfusion reactions in the therapeutic use of packed red blood cells. Some of those reactions are caused by the presence of white blood cells (WBCs). Both immunogenic and infectious transfusion reactions are significantly influenced by the level of white blood cell contamination. Materials and methods: The flexible in-line red cell filtration system Leucoflex LCR Diamond (Macopharma) was investigated. According to manufacturer information the system has a smaller filter surface (46cm 2) than the previous filter LCR-5 (53cm 2). Main difference with the previous model is the rhomboid design. The filter tube connections are not at the level of the centre edge, but at two opposite corners. Eighteen red cell concentrates were produced under Good Manufacturing Practice conditions in routine operation. To ensure the quality of the filter system every 7days metabolic parametres such as WBC count, haemoglobin content, haemolysis rate, potassium load, pH and ATP content were analysed over a storage period of 49days. Results: The mean product volume was 260.7mL after filtration. Average haemoglobin content was 51.8g per unit and WBC contamination was 0.02×10 6per unit. Haemolysis rate was 0.05% directly after filtration and 0.20% at the end of storage. Immediately after filtration the potassium concentration was 1.3mmol/L and the pH was 7.37. During whole storage time the ATP level was maintained above 2.0μmolperghaemoglobin. Conclusion: The tested filtration system is suitable for quality-assured production of red blood cell concentrates meeting national and international guidelines.