From Development to Implementation: Adjusting the Hematocrit of Deglycerolized Red Cell Concentrates to Meet Regulatory Standards

Abstract

Background: Before transfusion, thawed frozen red cell concentrates (RCCs) must be deglycerolized. In order to ensure that these products meet regulatory standards for hematocrit, an approach to manipulate hematocrit post deglycerolization was developed and implemented. Methods: Glycerolized and frozen RCCs were thawed and deglycerolized using the COBE 2991 cell processor, and the final product's hematocrit was adjusted by addition of various volumes of 0.9% saline / 0.2% dextrose. The in vitro quality of RCCs (hematocrit, hemolysis, hemoglobin content, volume, recovery, ATP, supernatant potassium, and others) were compared to Canadian Standards Association (CSA) and other standards for deglycerolized RCCs. Results: Addition of saline/dextrose re-suspension solution in a range of 65-90 g post deglycerolization led to acceptable hematocrits. In the pilot study, this approach resulted in RCCs meeting all CSA standards for deglycerolized RCCs, with stimulation of RBC metabolism demonstrated by increased ATP concentration. In the validation phase, results were similar, although the CSA hemolysis standard was not met. Pre- and post-implementation data confirmed that manipulated RCCs met CSA hematocrit standards. Conclusion: This process was implemented at Canadian Blood Services to provide deglycerolized RCCs that meet the CSA hematocrit standard. However, pre- and post-implementation data reveal that this deglycerolization process is not sufficient to have RCCs consistently meet hemolysis standards.