Evaluation of in Vivo Recovery of AS-3 Leukoreduced Red Cells Stored for 35 Days in CLX® Plastic Blood Bags.

BACKGROUND: Although the plasticizer DEHP used in blood bags is not known to cause any clinical problems, there is some concern because relatively high amounts migrate into the red cell product. Currently CLXÒ bags without DEHP are licensed for 21-day red cell storage. Leukoreduction has been shown to decrease the storage lesion of red cells. This study evaluated the in vivo recovery and in vitro quality of leukoreduced AS-3 red cells stored for 35 days in the non-DEHP CLXÒ bags. METHODS: Twenty units of whole blood were collected in CLXÒ LeukotrapÒ RC-PL System (Pall Medical). Ten units were held at room temperature (RT) for 6-7 hours before processing and removal of white cells by filtration. The other ten were held at RT for 8 hours then refrigerated for 16 hours at 1-6°C before processing and filtration. Units were stored for 35 days from phlebotomy under standard condition. Pre and post filtration samples as well as post storage samples were obtained. FINDINGS: The table below shows the most relevant post storage mean(SD) data. CONCLUSIONS: This study showed that red cells collected using the CLXÒ LeukotrapÒ RC-PL System, whether filtered within 8 hours or held for 24 hours prior to processing, had a mean 24 hours recovery greater than 75%, and hemolysis was well below 1% after 35 days of storage. Results of this study indicate red cells processed and stored in this system are an acceptable transfusion product. [ABSTRACT FROM AUTHOR]