Leukoreduction in Tennessee |
||||||||||||||||||||||||||||||||||||||
Return to Topics Page About TABB Where to Donate Blood in Tennessee Upcoming TABB Meetings |
Universal Leukoreduction (ULR) in Tennessee The primary purpose of drawing blood from donors is to increase the number of hemoglobin-containing red blood cells in recipients. In recent years, there has been increased attention paid to the adverse effects caused by the presence of white blood cells (leukocytes) in blood transfused to patients. There is now a considerable body of literature devoted to this subject. It has been shown unequivocally that removal of the white cells avoids refractoriness to platelets, reduces non-hemolytic febrile reactions, and avoids the transmission of cytomegalovirus (CMV). It also seems likely that leukoreduction avoids immunosuppression which is undesirable possibly leading to an increased mortality particularly in those patients receiving large amounts of blood.1 Thus, it has been proposed that all blood given to patients be leukoreduced (LR).2 Universal leukoreduction (ULR) is the term. Under this program, a donor center will only issue Red Blood Cells which are leukoreduced. (AABB Standards for Blood Banks and Transfusion Services, 20th edition, defines Red Blood Cells Leukocytes Reduced as those units which have been ". . . prepared by a method known to retain at least 85% of the original red cells and to reduce the leukocyte number in the final component to less than 5 x 106 leukocytes.") We thought it would be of interest to see which donor centers in the State of Tennessee had implemented ULR. A phone and e-mail survey was carried out early in November 2000 and the results are tabulated below.
Kingsport/Bristol facilities have not begun ULR. The big concern is cost. Dr. Nancy L. Van Buren, medical director of the Marsh Regional Blood Bank in Kingsport explains, ". . . but at this point the cost really is significant to hospitals that are teetering on the edge of financial viability due to BBA cut-backs (which still aren't fully implemented, unless Congress passes some relief) and other financial constraints in the current healthcare climate. Every dollar spent is closely scrutinized at this point in time by many hospital systems." Ed Scott, M.D., Medical Director of LifeBlood in Memphis, tells us that "For red cells, we attempt to prestorage filter all components, but a small number (less than 5% of local collections) are sent unfiltered. This is most often due to the need to release product early due to short supply. We continue to import about 45,000 red cells a year from other blood centers and 10-20% are currently leukocyte-reduced. We expect that percentage to increase in the coming year as more centers, from which we buy products, obtain their licenses for LR red cells." In September 1998 the FDA's Blood Products Advisory Committee was asked to decide whether the benefits of ULR outweigh its risks. The vote was 13-0 with 3 abstentions. On June 16, 2000 the FDA announced that it will not formally recommend ULR in the guidance document it is preparing. But Jay Epstein, MD, director of the FDA's Office of Blood Research and Review, said, "FDA remains convinced at a scientific level independent of cost that ULR is an improvement in safety and purity." There is no estimated date for the appearance of this guidance document. Thus, all indications are that the implementation of ULR in the U.S. will be voluntary. In the meantime, Canada and several Western European nations have gone to ULR. Currently, the European nations using ULR are France, Germany, Japan, Portugal, and the UK. Note: The FDA has now published a Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion - 1/23/2001. See this at http://www.fda.gov/cber/guidelines.htm#leuk. Francis S. Jones, M.D. 1 Houbiers JG, Brand A, van de Watering LM, Hermans J, Verwey PJ, Bijnen AB, Pahlplatz P, Eeftinck Schattenkerk M, Wobbes T, de Vries JE, et al. Randomised controlled trial comparing transfusion of leucocyte-depleted or buffy-coat-depleted blood in surgery for colorectal cancer. Lancet 1994 Aug 27;344(8922):573-8. [medline] 2 |
|||||||||||||||||||||||||||||||||||||
