Recipient clinical risk factors predominate in possible transfusion-related acute lung injury.

BACKGROUND: Possible transfusion-related acute lung injury (pTRALI) cases by definition have a clear temporal relationship to an alternative recipient risk factor for acute respiratory distress syndrome (ARDS). We questioned whether transfusion factors are important for the development of pTRALI. STUDY DESIGN AND METHODS: In this nested case-control study, we prospectively identified 145 consecutive patients with pTRALI and randomly selected 163 transfused controls over a 4-year period at the University of California at San Francisco and the Mayo Clinic (Rochester, Minnesota). RESULTS: For pTRALI, we found evidence against transfusion being important: receipt of plasma from female donors (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.29-2.3; p = 0.70), total number of units transfused (OR, 0.99; 95% CI, 0.89-1.10; p = 0.86), and number of red blood cell and whole blood units transfused (OR, 0.78; 95% CI, 0.59-1.03; p = 0.079). In contrast, we found that risk for pTRALI was associated with additional recipient factors: chronic alcohol abuse (OR, 12.5; 95% CI, 2.8-55; p < 0.001), current smoker (OR, 4.2; 95% CI, 1.67-10.8; p = 0.0024), shock before transfusion (OR, 4.6; 95% CI, 2.0-10.7; p < 0.001), and positive fluid balance before transfusion (OR, 1.32/L; 95% CI, 1.20-1.44; p < 0.001). CONCLUSION: Recipient risk factors for ARDS rather than transfusion risk factors predominate in pTRALI.

A cross-sectional pilot study of blood utilization in 27 hospitals in Northern California.

OBJECTIVES: To gather benchmarking data on blood utilization so as to inform blood management strategies at regional hospitals. METHODS: We conducted a cross-sectional pilot study of 40 regional hospitals in Northern California using a paper-based survey designed to capture blood component utilization and transfusion management practices. The data were analyzed based on size and complexity of the respondent hospitals. RESULTS: Twenty-seven (68%) of 40 hospitals responded, ranging in size from 23- to 600-bed facilities. Results showed a wide range of transfusions for each component. All hospitals reported some level of blood utilization oversight in place. Overall, 88.5% had a computerized laboratory information system, of which 17% performed an electronic cross-match. Transfusion triggers for RBCs, platelets, plasma, and cryoprecipitate were in use in 61.5%, 65.4%, 57.7%, and 46.2% of hospitals, respectively. CONCLUSIONS: There is awareness of the need for transfusion oversight. However, the findings show a wide spectrum of transfusion practice, and high-yield measures, such as electronic cross-match and transfusion triggers, have not been uniformly implemented. The results indicate that there is a role for blood centers to assist client hospitals to maximize their efficiency and reduce blood utilization.

Prospective study on the clinical course and outcomes in transfusion-related acute lung injury*.

OBJECTIVE: Transfusion-related acute lung injury is the leading cause of transfusion-related mortality. A prospective study using electronic surveillance was conducted at two academic medical centers in the United States with the objective to define the clinical course and outcomes in transfusion-related acute lung injury cases. DESIGN: Prospective case study with controls. SETTING: University of California, San Francisco and Mayo Clinic, Rochester. PATIENTS: We prospectively enrolled 89 patients with transfusion-related acute lung injury, 164 transfused controls, and 145 patients with possible transfusion-related acute lung injury. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients with transfusion-related acute lung injury had fever, tachycardia, tachypnea, hypotension, and prolonged hypoxemia compared with controls. Of the patients with transfusion-related acute lung injury, 29 of 37 patients (78%) required initiation of mechanical ventilation and 13 of 53 (25%) required initiation of vasopressors. Patients with transfusion-related acute lung injury and possible transfusion-related acute lung injury had an increased duration of mechanical ventilation and increased days in the ICU and hospital compared with controls. There were 15 of 89 patients with transfusion-related acute lung injury (17%) who died, whereas 61 of 145 patients with possible transfusion-related acute lung injury (42%) died and 7 of 164 of controls (4%) died. Patients with transfusion-related acute lung injury had evidence of more systemic inflammation with increases in circulating neutrophils and a decrease in platelets compared with controls. Patients with transfusion-related acute lung injury and possible transfusion-related acute lung injury also had a statistically significant increase in plasma interleukin-8, interleukin-10, and interleukin-1 receptor antagonist posttransfusion compared with controls. CONCLUSIONS: In conclusion, transfusion-related acute lung injury produced a condition resembling the systemic inflammatory response syndrome and was associated with substantial in-hospital morbidity and mortality in patients with transfusion-related acute lung injury compared with transfused controls. Patients with possible transfusion-related acute lung injury had even higher in-hospital morbidity and mortality, suggesting that clinical outcomes in this group are mainly influenced by the underlying acute lung injury risk factor(s).

Cancer Incidence and Mortality in a Cohort of US Blood Donors: A 20-Year Study.

Blood donors are considered one of the healthiest populations. This study describes the epidemiology of cancer in a cohort of blood donors up to 20 years after blood donation. Records from donors who participated in the Retroviral Epidemiology Donor Study (REDS, 1991-2002) at Blood Centers of the Pacific (BCP), San Francisco, were linked to the California Cancer Registry (CCR, 1991-2010). Standardized incidence ratios (SIR) were estimated using standard US 2000 population, and survival analysis used to compare all-cause mortality among donors and a random sample of nondonors with cancer from CCR. Of 55,158 eligible allogeneic blood donors followed-up for 863,902 person-years, 4,236 (7.7%) primary malignant cancers were diagnosed. SIR in donors was 1.59 (95% CI = 1.54,1.64). Donors had significantly lower mortality (adjusted HR = 0.70, 95% CI = 0.66-0.74) compared with nondonor cancer patients, except for respiratory system cancers (adjusted HR = 0.93, 95% CI = 0.82-1.05). Elevated cancer incidence among blood donors may reflect higher diagnosis rates due to health seeking behavior and cancer screening in donors. A "healthy donor effect" on mortality following cancer diagnosis was demonstrated. This population-based database and sample repository of blood donors with long-term monitoring of cancer incidence provides the opportunity for future analyses of genetic and other biomarkers of cancer.

Transfusion-related acute lung injury: incidence and risk factors.

Transfusion-related acute lung injury (TRALI) is the leading cause of transfusion-related mortality. To determine TRALI incidence by prospective, active surveillance and to identify risk factors by a case-control study, 2 academic medical centers enrolled 89 cases and 164 transfused controls. Recipient risk factors identified by multivariate analysis were higher IL-8 levels, liver surgery, chronic alcohol abuse, shock, higher peak airway pressure while being mechanically ventilated, current smoking, and positive fluid balance. Transfusion risk factors were receipt of plasma or whole blood from female donors (odds ratio = 4.5, 95% confidence interval [CI], 1.85-11.2, P = .001), volume of HLA class II antibody with normalized background ratio more than 27.5 (OR = 1.92/100 mL, 95% CI, 1.08-3.4, P = .03), and volume of anti-human neutrophil antigen positive by granulocyte immunofluoresence test (OR = 1.71/100 mL, 95% CI, 1.18-2.5, P = .004). Little or no risk was associated with older red blood cell units, noncognate or weak cognate class II antibody, or class I antibody. Reduced transfusion of plasma from female donors was concurrent with reduced TRALI incidence: 2.57 (95% CI, 1.72-3.86) in 2006 versus 0.81 (95% CI, 0.44-1.49) in 2009 per 10 000 transfused units (P = .002). The identified risk factors provide potential targets for reducing residual TRALI.

Genetic research in the blood bank: acceptability to Northern California donors.

BACKGROUND: Blood banks have large altruistic donor populations and existing infrastructure that make them attractive sites for genetic epidemiologic research, but donors' willingness to participate and the impact on blood donation are unknown. STUDY DESIGN AND METHODS: A total of 2162 blood donors in Northern California responded to a cross-sectional questionnaire in August and September 2007. Participants were asked their likelihood of participation and future blood donation under three different scenarios: identity-linked genetic research, identity-unlinked genetic research, and genetic testing as a service. RESULTS: The majority of blood donors indicated that they would be likely or very likely to participate in identity-linked genetic research (67%) and in identity-unlinked genetic research (54%). While older donors and more frequent donors were more likely to participate in identity-linked research, younger, Caucasian, more educated, and more frequent donors were more likely to participate in identity-unlinked research. Less than 10% of donors indicated they would be less likely to donate blood in the future if genetic research was conducted at blood banks. More than 75% of donors would be interested in genetic testing as an optional service at the blood bank, but more than 20% of donors would be less likely to donate if such a service was offered. CONCLUSION: Overall, we found that the majority of blood donors would be likely to participate in genetic research and that less than 10% would be less inclined to donate if such research was conducted by blood banks.

Minority and foreign-born representation among US blood donors: demographics and donation frequency for 2006.

BACKGROUND: Historically, minority populations have represented only a small proportion of US blood donors, but recent trends in immigration and potential blood shortages emphasize the need for recruitment strategies to increase minority donations. STUDY DESIGN AND METHODS: Donation data from a network of six US blood centers for 2006 were analyzed. Race/ethnicity, country of birth, and educational attainment data were collected specifically for the study and assessed for their influence on donation behavior. Logistic regression was used to determine independent associations with repeat donors status and annual donation frequency. RESULTS: A total of 1,288,998 donations from 729,068 donors were studied; most donors had data on race/ethnicity (97.1%) and country of birth (93.1%). The proportion of minority donors differed by blood center, with African American donors (16%) most common at the Southeastern blood center and Asian (12%), Hispanic (13%), and foreign-born donors (13%) most common at the Northern California blood center. Minority donors and those born in Mexico or Latin America were younger than white donors. Minority and non-US-born donors were less likely than white and US-born donors to be repeat donors (odds ratio [OR], 0.60-0.78), and most were less likely to give two or more annual donations (OR, 0.82-1.11). CONCLUSION: Minority and Mexico/Latin America-born donors represent a younger and often first-time donor population compared to white and US-born donors, but their annual donation frequency was only slightly lower than white and US-born donors. Increasing the retention and donation frequency of minorities will be important for supplementing the blood supply.

Blood donor satisfaction and intention of future donation.

BACKGROUND: New regulatory requirements for donor eligibility challenge blood centers to recruit and retain enough donors. This study evaluated correlations between overall satisfaction with the donation process and donor demographics and the effect of both on a donor's intent to return. STUDY DESIGN AND METHODS: An anonymous, self-administered questionnaire was given to donors at multiple sites of one blood center over a 3-week period. First-time and repeat donors were asked questions on demographic characteristics, satisfaction with the current donation process, motivation for current and future donations, and intent to return. RESULTS: More than 75 percent of donors rated the overall donation process at 9 or 10 on a scale of 10 (mean, 9.19; standard deviation, 1.09), with female, high school-educated, and first-time donors giving higher satisfaction ratings than male, college-educated, and repeat donors, respectively (all p < 0.001). Donor satisfaction was correlated with intent to return for another donation (p = 0.002). For the current donation, donors rated altruistic motivations most highly. Medical testing was the most highly rated incentive for future donations, followed by frequent donor programs and convenient donation times and locations; preferences varied by demographic subgroup. CONCLUSIONS: Blood donor satisfaction varies among demographic and donation history subgroups and is positively correlated with the intent to return for future donation. Although the primary motivation among all donors was altruism, incentives to future donation may need to be tailored according to demographic subgroups.

Evaluation of a new Trypanosoma cruzi antibody assay for blood donor screening.

BACKGROUND: This multicenter prospective study was designed to evaluate the performance characteristics of a new commercially available enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies to Trypanosoma cruzi in blood donors, the ORTHO T. cruzi ELISA Test System (Ortho-Clinical Diagnostics). STUDY DESIGN AND METHODS: Assay specificity was evaluated among 40,665 serum and ethylenediaminetetraacetate (EDTA) plasma specimens from volunteer blood donors and 481 T. cruzi antibody-negative specimens from a high-risk population. Sensitivity was evaluated among 106 T. cruzi-infected subjects identified by parasite detection, among 93 radioimmunoprecipitation assay (RIPA)-positive specimens from high-risk subjects, and 662 specimens presumed positive for the presence of T. cruzi antibodies by serologic methods. Also assessed were the equivalence of serum and plasma as specimen sources, performance equivalence of automated and semiautomated processing methods, nonspecific reactivity in specimens from other disease states or clinical conditions, and assay precision. RESULTS: Assay specificity was 99.998 percent in volunteer blood donors and 99.4 percent among high-risk subjects. Sensitivity was 100 percent among specimens positive by parasite detection, or by serologic methods, and 98.9 percent among RIPA-positive specimens from high-risk subjects. No differences were demonstrated between serum and plasma or between semiautomated and automated processing methods. Cross-reactivity was observed with known positive leishmaniasis specimens. Total inter- and intraassay variability was less than 10 percent with both the automated and the semiautomated methods. CONCLUSION: The ORTHO T. cruzi ELISA Test System is an effective, qualitative assay for screening blood donors for immunoglobulin G antibodies to T. cruzi. The assay was licensed for donor screening by the FDA in December 2006.

The consequences of temporary deferral on future whole blood donation.

BACKGROUND: The consequences of temporary deferral are not well understood. This study sought to investigate blood donor return after deferral expiration. STUDY DESIGN AND METHODS: A retrospective cohort analysis of allogeneic whole-blood donation was conducted. All deferred donors and a random sample of eligible donors were identified from the year 2000, with subsequent blood center visits through December 2005 captured. Stratified results are reported as the percentage returning, rates of return, and time to return. Measures of statistical association and Cox regression modeling are reported. RESULTS: For first-time (FT) donors, 25 percent of temporarily deferred donors returned during the 5-year follow-up period compared to 47 percent of eligible donors (p < 0.0001); for repeat donors, 81 and 86 percent of deferred and eligible donors returned, respectively (p < 0.0001). Depending on the deferral category, 14 to 31 percent of FT and 58 to 90 percent of repeat donors returned. Rates (per year) of successful donation during the follow-up period were 0.09 for index-deferred FT donors, 0.28 for eligible FT donors, 1.0 for deferred repeat donors, and 1.45 for eligible repeat donors. Multivariate modeling indicated that in addition to deferral, age, sex, race, and education were associated with return in both FT and repeat donors. CONCLUSION: The effects of deferral were more pronounced than expected, affecting both FT and repeat donors. For FT donors, the type and duration of deferral, while important, were not as relevant as hypothesized because so few returned, suggesting the need to develop appropriate interventions to recapture those donors likely to be eligible.

A randomized trial of blood donor recruitment strategies.

BACKGROUND: Improvement in donor return rates, especially among first-time donors, may significantly improve the blood supply. There are few rigorous studies of the effectiveness of various approaches to donor recruitment, however. STUDY DESIGN AND METHODS: By use of a single-blind, randomized trial design, 6919 post-September 11, 2001, first-time donors were randomly assigned into the following intervention arms: T-shirt incentive versus none, recruitment scripts with a patient story (Script A) versus a complimentary message including the donor's blood type (Script B), and telephone versus e-mail recruitment. Our primary outcome was a second donation within 6 months. Rate ratios (RRs) and 95 percent confidence intervals (95% CIs) were calculated with Taylor series methods. RESULTS: A total of 1421 (20.5%) first-time donors returned within the 6 months, including 1252 with a second and 169 with both second and third donations. The T-shirt incentive was not effective in increasing returns compared to no incentive (20.5% vs. 20.6%; RR, 0.99; 95% CI, 0.91-1.09). Script A was significantly more effective than Script B (22.2% vs. 18.9%; RR, 1.18; 95% CI, 1.07-1.29). E-mail was substantially less effective than telephone recruitment (13.2% vs. 27.8%; RR, 0.48; 95% CI, 0.40-0.57). CONCLUSIONS: A T-shirt incentive had no apparent effect, but an empathetic message significantly improved the return donation rate. E-mail recruitment was substantially less effective than telephone recruitment, perhaps due to technical problems. The study illustrates the utility of the randomized clinical trial study design for testing donor recruitment strategies.

Blood donor and component management strategies to prevent transfusion-related acute lung injury (TRALI).

OBJECTIVE: Discuss the pros and cons of using donor and blood product-management strategies to prevent transfusion-related acute lung injury (TRALI). DATA SOURCE: A review of the literature was performed. RESULTS: Despite therapeutic advances in pulmonary and critical care medicine, TRALI is now considered to be one of the leading causes of transfusion-associated mortality, and thus determining how to prevent TRALI is extremely important. Donor and product-management strategies to prevent this life-threatening condition have been suggested, but because of gaps in our understanding of TRALI, blood-bankers do not know how beneficial these interventions will be, nor the amount of potential harm-such as decreasing the availability of blood-that could arise if they were implemented. This article discusses the advantages and disadvantages of the various preventive measures that have been described in the literature. CONCLUSIONS: Preventing TRALI poses a difficult challenge for blood-banking experts, because it is unknown which measures will be effective in decreasing the incidence of TRALI and which could have significant drawbacks. Only additional research into TRALI prevention will provide the answers on how to best protect patients from this potentially fatal reaction.

The impact of male-to-male sexual experience on risk profiles of blood donors.

BACKGROUND: Men who have had sex with men (MSM) since 1977 are permanently deferred from donating blood. Excluding only men who engaged in male-to-male sex within either the prior 12 months or 5 years has been proposed. Little is known about infectious disease risks of MSM who donate blood. STUDY DESIGN AND METHODS: Weighted analyses of data from an anonymous mail survey of blood donors were conducted to examine the characteristics of men reporting male-to-male sex during specified time periods. RESULTS: Of the 25,168 male respondents, 569 (2.4%) reported male-to-male sex, 280 (1.2%) since 1977. Compared to donors who did not report male-to-male sex, the prevalence of reactive screening test results was higher among donors who reported the practice within the past 5 years (< or =12 months odds ratio [OR] 5.3, 95% confidence interval [CI] 2.6-10.4; >12 months to 5 years, OR 7.1, 95% CI 1.2-41.7); however, no significant difference was found for donors who last practiced male-to-male sex more than 5 years ago (>5 years-after 1977, OR 1.4, 95% CI 0.7-2.6; 1977 or earlier, OR 1.6, 95% CI 0.7-3.7). The prevalence of unreported deferrable risks (UDRs) other than male-to-male sex was significantly higher for all donors who reported male-to-male sex with ORs ranging from 3.1 to 18.9 (p < or = 0.01). CONCLUSIONS: No evidence was found to support changing current policy to permit donations from men who practiced male-to-male sex within the past 5 years. For donors with a more remote history of male-to-male sex, the findings were equivocal. A better understanding of the association between male-to-male sex and other UDRs appears needed.

Quantifying losses to the donated blood supply due to donor deferral and miscollection.

BACKGROUND: Donors are deferred for multiple reasons. Losses related to disease marker rates are well established. Donor and donation losses for other reasons, however, have not been extensively quantified. STUDY DESIGN AND METHODS: To quantify these losses, three data sets from the Blood Centers of the Pacific were combined, permitting detailed analysis of year 2000 allogeneic whole-blood donations. RESULTS: During 2000, 13.6 percent of 116,165 persons who presented for donation were deferred at presentation. Short-term deferral accounted for 68.5 percent (hematocrit was most common at 60%); long-term deferral accounted for 21 percent (travel to a malarial area and tattoo or other nonintravenous drug use needle exposure were most common at 59 and 29%, respectively); and multiple-year or permanent deferral accounted for 10.5 percent (UK travel [variant Creutzfeldt-Jakob disease] risk and emigration from a malarial area were most common at 38 and 11%, respectively). Disease-marker-reactive donations represented 0.9 percent of donor outcomes. The prevalence of deferral and also miscollection (under- and overweight units) varied by age, sex, and first-time versus repeat donor status. Overall, miscollection led to a loss of 3.8 percent of 100,141 collections, ranging from 1.9 percent in repeat male donors 40 to 54 years of age to 10.7 percent in first-time female donors 16 to 24 years of age. CONCLUSION: Loss of units from both first-time and repeat donors due to temporary deferral and loss of units from miscollection are more common events than losses due to disease marker testing. Some of these losses may be avoidable and could increase the blood supply without having to recruit new donors.

Estimating blood donor loss due to the variant CJD travel deferral.

BACKGROUND: The FDA recommended new travel deferrals in May 2002 to prevent the potential transmission of variant CJD (vCJD). The predicted impact of such deferrals on the blood supply was controversial. STUDY DESIGN AND METHODS: We distributed anonymous, self-administered questionnaires to donors over 2 weeks in April 2002. Two thousand surveys were allocated to each of five geographic groupings of blood centers in the western and central US. Results were analyzed with chi-squared tests and logistic regression. RESULTS: Of 9800 surveys, 7405 (76%) were returned and analyzed. Overall, 257 (3.47%; 95% CI, 3.05-3.89) donors responding to the survey met the expanded May and November 2002 FDA vCJD travel criteria for deferral. Deferral rates ranged from 1 percent or less in Northern and Southern centers, 3 to 4 percent in San Francisco, California, and Scottsdale, Arizona, to over 13 percent in El Paso, Texas (p < 0.0001). Service at a European military base was the most common reason for deferral, whereas in San Francisco most deferrals were for UK and European travel or residence. The vCJD deferral was also associated with ages 30 through 49 years and with male gender. During June through September 2002, observed deferral rates were 1.6 percent at the same centers. CONCLUSIONS: Predicted deferrals due the new vCJD travel criteria depend upon the number of military donors at a blood center, as well as on the age and gender of donors. Actual deferrals were lower than predicted by an anonymous survey.