Red Cell Apheresis with Automated In-Line Filtration

Abstract

Background: The aim of this study was to provide data on concurrent red blood cell (RBC) and platelet (PLT) apheresis with RBC in-line leukoreduction and automated addition of saline-adenine-glucose-mannitol (SAGM) using the new version (V6.0) of Trima Accel®. Methods: In this two-center paired study, each subject completed a test and a control procedure with an interval of 9 weeks between procedures. In the test arm, single RBC and PLT units were collected on the Trima Accel V6.0 (in-line leukofiltration and automated addition of SAGM). In the control arm, they were collected on Trima Accel V5.1/V5.2 (post-collection leukoreduction, manual SAGM addition). RBC percent hemolysis, potassium concentration and adenosine triphosphate over storage, hemoglobin (Hb) yield, and residual white blood cells (WBC) were determined. Results: 34 subjects successfully completed both test and control procedures. Post-storage hemolysis was similar in both groups, and all values were less than 0.8% for both arms. Residual WBC counts in all RBC units were less than 1 × 10⁶/unit. In-line processed RBC units (V6.0) have a significantly higher volume and more Hb/unit due to filtration recovery improvements. All procedures were well tolerated by the subjects. Conclusion: In-line filtration and automated addition of storage solution on Trima Accel V6.0 allows collection of ready-to-use RBC units that meet EU requirements.

Red cell apheresis: pros and cons

“…The higher standardization of automatically collected RBC units is also of advantage for the applications of Good Manufacturing Practices due to a better process control in all steps of component production . Published data demonstrated very good in vitro quality of single‐dose and 2RBC products obtained with all collection systems and full compliance with regulatory requirements . Notably, with respect to some storage parameters (ATP and 2–3 DPG content, extent of haemolysis, amount of free K+ and free Hb) and rheology characteristics, a better quality of automatically collected RBC components was reported compared to those from WB collections .…”