In vivo survival of apheresis RBCs, frozen with 40-percent (wt/vol) glycerol, deglycerolized in the ACP 215, and stored at 4 degrees C in AS-3 for upto 21 days

BACKGROUND: The FDA has approved the storage of frozen RBCs at -80 degreesC for 10 years and the postwash storage at 4 degreesC for no more than 24 ho urs. The 4 degreesC postwash storage period is limited to 24 hours, because the current deglycerolization systems are functionally open systems. STUDY DESIGN AND METHODS: Two units of RBCs were collected from each of 13 healthy male volunteers. The RBCs were collected in CP2D by the FDA-approve d protocol for an automated apheresis device (MCS, LN8150, Haemonetics) and were stored at 4 degreesC in AS-3 for 6 days. Using a single disposable gl ycerolization set in an automated, functionally closed system (ACP 215, Hae monetics) each unit was transferred to a 1000-mL PVC plastic bag and glycer olized to a concentration of 40-percent (wt/vol) glycerol and frozen at -80 degreesC. A single disposable deglycerolization set in the ACP 215 was use d to deglycerolize the 2 units from the same donor. The deglycerolized RBCs were stored at 4 degreesC in AS-3 for as long as 21 days. RESULTS: The mean +/- SD freeze-thaw-wash recovery value was 89.4 +/- 3 per cent. The residual hemolysis in the RBCs stored at 4 degreesC in AS-3 for 2 1 days after deglycerolization was 0.9 +/- 0.2 percent, and the units were negative for both aerobic and anaerobic bacteria. The mean Nageotte WBC cou nt was 9 x 10(6) per unit. When the deglycerolized RBCs were given as an au tologous transfusion after storage at 4 degreesC in AS-3 for the 7- to 18-d ay period, the mean +/- SD 24-hour posttransfusion survival was 77 +/- 7 pe rcent, and the index of therapeutic effectiveness was 69 +/- 8 percent. CONCLUSION: Two units of human RBCs collected from a single donor by aphere sis in the MCS using an LN8150 set can be glycerolized sequentially with a single disposable set and deglycerolized sequentially with another single d isposable set in the ACP 215. The previously frozen RBCs stored in AS-3 for 7 to 18 days at 4 degreesC had acceptable hemolysis and an acceptable mean 24-hour posttransfusion survival value and index of therapeutic effectiven ess.