Effective reduction of transfusion-related acute lung injury risk with male-predominant plasma strategy in the American Red Cross (2006-2008).

BACKGROUND: Plasma components from female donors were responsible for most cases of transfusion-related acute lung injury (TRALI) reported to the American Red Cross (ARC) between 2003 and 2005. Consequently, we began preferentially distributing plasma from male donors for transfusion in 2006 and evaluated the effect on reported TRALI cases in the ensuing 2 years. STUDY DESIGN AND METHODS: Suspected TRALI cases reported to the ARC Hemovigilance Program in calendar years (CY) 2006, 2007, and 2008 are described. Any case involving a fatality was also independently reviewed by three ARC physicians and classified as probable TRALI or not TRALI. RESULTS: The percentage of plasma collected from male donors and distributed for transfusion increased each year from 55% in CY2006 to 79% in CY2007 and 95% in CY2008. Independent medical review of the 77 reported TRALI cases involving a fatality identified 38 cases as probable TRALI. Plasma was the only component transfused in six of these cases in 2006, five in 2007, and zero in 2008. Overall, the analysis of reported fatalities and nonfatal cases demonstrates that TRALI involving only plasma transfusion was significantly reduced in 2008 compared to 2006 (32 vs. 7 cases; odds ratio [OR] = 0.21; 95% confidence interval [CI] = 0.08-0.45), to a level that was no longer different from the rate of TRALI observed for RBC transfusion (4.0 vs. 2.3 per 10(6) distributed components; OR = 1.78; 95% CI = 0.67-4.36). CONCLUSIONS: Reported TRALI cases from plasma transfusion decreased in 2008 compared to the prior 2 years simultaneously with the conversion to male-predominant plasma for transfusion.

The American Red Cross donor hemovigilance program: complications of blood donation reported in 2006.

BACKGROUND: The American Red Cross (ARC) initiated a comprehensive donor hemovigilance program in 2003. We provide an overview of reported complications after whole blood (WB), apheresis platelet (PLT), or automated red cell (R2) donation and analyze factors contributing to the variability in reported complication rates in our national program. STUDY DESIGN AND METHODS: Complications recorded at the collection site or reported after allogeneic WB, apheresis PLT, and R2 donation procedures in 36 regional blood centers in 2006 were analyzed by univariate and multivariate logistic regression. RESULTS: Complications after 6,014,472 WB, 449,594 PLT, and 228,183 R2 procedures totaled 209,815, 25,966, and 12,282 (348.9, 577.5, and 538.3 per 10,000 donations), respectively, the vast majority of which were minor presyncopal reactions and small hematomas. Regional center, donor age, sex, and donation status were independently associated with complication rates after WB, PLT, and R2 donation. Seasonal variability in complications rates after WB and R2 donation correlated with the proportion of donors under 20 years old. Excluding large hematomas, the overall rate of major complications was 7.4, 5.2, and 3.3 per 10,000 collections for WB, PLT, and R2 procedures, respectively. Outside medical care was recorded at similar rates for both WB and automated collections (3.2 vs. 2.9 per 10,000 donations, respectively). CONCLUSION: The ARC data describe the current risks of blood donation in a model multicenter hemovigilance system using standardized definitions and reporting protocols. Reported reaction rates varied by regional center independently of donor demographics, limiting direct comparison of different regional blood centers.

Transfusion-related acute lung injury surveillance (2003-2005) and the potential impact of the selective use of plasma from male donors in the American Red Cross.

BACKGROUND: American Red Cross surveillance data on transfusion-related acute lung injury (TRALI) fatalities were analyzed to evaluate the association with components from donors with white blood cell (WBC) antibodies and to examine the potential impact of the selective transfusion of plasma from male donors. STUDY DESIGN AND METHODS: Suspected TRALI reports in 2003 through 2005 were identified and all fatalities were reviewed and classified by three physicians as "probable TRALI" or of "unrelated etiology," with independent review of the associated serologic investigation. Hospital investigational and reporting biases could not be fully controlled in this retrospective study. RESULTS: A total of 550 reports of suspected TRALI, including 72 fatalities, were investigated. The number of reports increased each year and the rate varied by geographic region. Retrospective review of fatalities revealed 38 cases of probable TRALI, the majority (24 of 38 [63%]) after plasma transfusion. A female, WBC antibody-positive donor was involved in 71 percent (27 of 38) of cases and in 75 percent (18 of 24) of cases involving plasma transfusion. Female antibody-positive donors were more likely to be associated with probable TRALI than with unrelated cases (p = 0.0001; odds ratio [OR], 9.5; 95% confidence interval [CI], 2.9-31.1]. The rate of probable TRALI among recipient fatalities was higher for plasma components (1:202,673; OR, 12.5; 95% CI, 5.4-28.9) and apheresis platelets (PLTs; 1:320,572; OR, 7.9; 95% CI, 2.5-24.8) compared to red cells (1:2,527,437). Male donors contributed 64.5 and 52.0 percent of distributed apheresis PLTs and plasma components, respectively, in 2005. CONCLUSION: Plasma components linked to female donors with WBC antibodies were responsible for the majority of probable TRALI fatalities. Prudent measures to limit transfusion of WBC antibody-containing plasma components may prevent as many as six fatalities per year in the Red Cross system.

Detection of bacterial contamination in apheresis platelet products: American Red Cross experience, 2004.

BACKGROUND: Routine quality control (QC) testing for bacterial contamination in apheresis platelet (PLT) products was implemented in all 36 regional blood centers of the American Red Cross in March 2004. STUDY DESIGN AND METHODS: PLT samples were cultured under aerobic conditions until the end of the product shelf life or when a positive reaction was indicated. To confirm the initial positive reaction, a new sample was taken from the unit for reculturing. All positive culture bottles were referred for bacterial isolation and identification. Bacterial testing data along with apheresis PLT collection information were collected for analysis. Reports and investigations of potential septic reactions to apheresis PLTs were reviewed. RESULTS: In the first 10 months of bacterial testing, 226 of 350,658 collections tested initially positive. Sixty-eight were confirmed on resampling to be bacterially contaminated for an overall confirmed-positive rate of 0.019 percent or 1 in 5157. Staphylococcus spp. (47.1%) and Streptococcus spp. (26.5%) were the most frequently isolated bacteria; Gram-negative bacteria accounted for 17.6 percent of the confirmed-positive products. Of the 354 apheresis PLT products derived from all 226 initial test-positive cases, 38 (10.7%) were transfused by the time the initial positive reaction was indicated. None of these transfused products, however, had a confirmed-positive bacterial screen and no patient who had been transfused with an unconfirmed-positive product had evidence of a septic transfusion reaction. Three high-probability septic transfusion reactions to screened, negative components were identified. In all three cases, a coagulase-negative Staphylococcus was implicated. CONCLUSION: Our experience demonstrates that bacterial testing of apheresis PLT products as a QC measure was efficiently implemented throughout the American Red Cross system and that this new procedure has been effective in identifying and preventing the transfusion of many, although not all, bacterially contaminated PLT units.

Change in CD34+ cell concentration during peripheral blood progenitor cell collection: effects on collection efficiency and efficacy.

BACKGROUND: An understanding of factors affecting CD34+ cell collection efficacy is essential to minimize donor toxicity and cost. STUDY DESIGN AND METHODS: Peripheral blood CD34+ cell (CD34) measurements were determined at various intervals before, during, and after automated cell collection (Cobe Spectra 6.0). The serial mean of multiple, intraprocedural CD34 levels was calculated for each procedure as an estimate of the mean, inlet-line CD34 level. RESULTS: The CD34+ concentration fell a mean of 30 percent in the first 30 to 70 minutes of collection. The degree of decline was inversely correlated with donor blood volume (BV), but was not due to hemodilution. The mean of the CD34 level before and after collection slightly overestimated the serial mean CD34 level. Cell yields, normalized for the CD34 level before collection, were higher from donors with larger BVs. CONCLUSIONS: The CD34 concentration rapidly decreased to a relative equilibrium level during the collection procedure. The degree of decrease in the CD34 level inversely correlated with the BV of the donor and was consistent with cell pooling in the collection set. The higher equilibrium CD34 levels in donors with larger BVs resulted in increased collection of CD34+ cells, and therefore, large-volume apheresis should be most efficient in these donors.