FDA Should Reduce Max Storage Limit of RBCs, Say Researchers
A group of researchers are asking the Food and Drug Administration (FDA) to reduce maximum storage limit for red blood cells from 6 weeks to 5 weeks, as long as there are sufficient blood supplies available. The recommendation is prompted by findings from a new study published in The Journal of Clinical Investigation.
“Our recommendation will be controversial, but we think we have real data to support it,” said co-leader of the study Steven Spitalnik, MD, medical director of the clinical laboratories at New York-Presbyterian/Columbia.
The researchers at New York Presbyterian enrolled 60 healthy adult volunteers, who had a single standard, autologous, leukoreduced, packed red cell transfusion after 1, 2, 3, 4, 5, or 6 weeks of storage.
Results showed that seven of the 9 patients who received the 6-week-old blood could not appropriately metabolize the damaged cells within hours after transfusion, releasing large amounts of iron into the bloodstream.
Transfusion of blood stored for 6 weeks showed increases in AUC for serum iron (P<0.01), transferrin saturation (P<0.001), and nontransferrin-bound iron (P<0.001) when compared with the transfusions of blood stored from 1 to 5 weeks. Longer storage time was also tied to decreasing posttransfusion red cell recovery (P=0.002), decreasing elevations in hematocrit (P=0.02), and increasing serum ferritin (P<0.0001).
Increased amounts of iron in the blood can lead to serious complications for patients with existing infections. The researchers concluded that "the current results provide unequivocal evidence that the transfusion of red cells stored for 6 weeks exceeds the physiologic capacity of healthy volunteers to process the iron released from the catabolism of cleared red cells."
“The U.K., Ireland, the Netherlands, and the National Institutes of Health have limited storage to 35 days, and we think that can be achieved throughout the U.S. without seriously affecting the blood supply,” said Dr. Spitalnik.
For more information visit JCI.org.