A multicenter study of in vitro and in vivo values in human RBCs frozen with 40-percent (wt/vol) glycerol and stored after deglycerolization for 15 days at 4 degrees C in AS-3: assessment of RBC processing in the ACP 215

BACKGROUND: The FDA has approved the storage of frozen RBCs at -80 degreesC for 10 years. After deglycerolization, the RBCs can be stored at 4 degrees C for no more than 24 hours, because open systems are currently being used. Five laboratoris have been evaluating an automated, functionally closed sy stem (ACP 215, Haemonetics) for both the glycerolization and deglycerolizat ion processes. STUDY DESIGN AND METHODS: Studies were performed at three military sites an d two civilian sites. Each site performed in vitro testing of 20 units of R BCs. In addition, one military site and two civilian sites conducted autolo gous transfusion studies on ten units of previously frozen, deglycerolized RBCs that had been stored at 4 degreesC in AS-3 for 15 days. At one of the civilian sites, 10 volunteers received autologous transfusions on two occas ions in a randomized manner, once with previously frozen RBCs that had been stored at 4 degreesC in AS-3 for 15 days after deglycerolization and once with liquid-preserved RBCs that had been stored at 4 degreesC in AS-1 for 4 2 days. RESULTS: The mean +/- SD in vitro freeze-thaw-wash recovery value was 87 +/ - 5 percent; the mean +/- SD supernatant osmolality on the day of deglycero lization was 297 +/- 5 mOsm per kg of H2O, and the mean +/- SD percentage o f hemolysis after storage at 4"C in AS-3 for 15 days was 0.60 +/- 0.2 perce nt. The paired data from the study of 10 persons at the civilian site showe d a mean +/- SD 24-hour posttransfusion survival of 76 +/- 6 percent for RB Cs that had been stored at 4"C for 15 days after deglycerolization and 72 /- 5 percent for RBCs stored at 4"C in AS-1 for 42 days. At the three sites at which 24-hour posttransfusion survival values were measured by three do uble-label procedures, a mean +/- SD 24-hour posttransfusion survival of 77 +/- 9 percent was observed for 36 autologous transfusions to 12 females an d 24 males of previously frozen RBCs that had been stored at 4 degreesC in AS-3 for 15 days after deglycerolization. CONCLUSION: The multicenter study showed the acceptable quality of RBCs tha t were glycerolized and deglycerolized in the automated ACP 215 instrument and stored in AS-3 at 4 degreesC for 15 days.