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.     

Patterns of age- and sex-specific prevalence of major blood-borne infections in United States blood donors, 1995 to 2002: American Red Cross blood donor study

BACKGROUND: The American Red Cross has been maintaining a research database of all blood donations, including all testing results for infectious disease markers, since 1995. This study analyzes the temporal trends of major blood-borne infections among blood donors. STUDY DESIGN AND METHODS: Temporal trends for age- and sex-specific prevalence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis infections in US blood donors were analyzed based on linear trend or time series model or other models as appropriate. RESULTS: From 1995 to 2002, significant declines have been observed for infections that used to be at relatively higher levels. Declines in prevalence were slower among first-time donations than repeat donations. There was an increase in prevalence of anti-HCV among first-time male donors of 50 to 59 years of age. Anti-HIV prevalence appeared to have increased among first-time male donors of 30 to 39 years of age since 2000. CONCLUSION: Different sex and age groups showed various patterns of decline and even signs of increase. The increasing prevalence among some age and sex groups may merit further investigation.     

Demographic differences in estimated blood donor eligibility prevalence in the United States

BACKGROUND: The prevalence of blood donor eligibility factors has a major impact on the availability of blood donors and thus the blood supply in the United States. The prevalence of these factors may differ between demographic groups and thus help explain the differences in blood donation rates. STUDY DESIGN AND METHODS: The study population (18‐69 years old who were African American [AA], white, or Hispanic) was 185,073,489. Forty eligibility factors determined by US Food and Drug Administration's Code of Federal Regulations and AABB Standards for Blood Banks and Transfusion Services were used to calculate whole blood donation eligibility rates. Eligibility data were obtained from the 2007 to 2008 National Health and Nutrition Examination Survey, National Ambulatory Medical Care Survey, US Census Bureau, and Centers for Disease Control and Prevention. Eligibility rates were determined by race/ethnicity, sex, and age groups (18‐39 and 40‐69 years). RESULTS: In 2007 to 2008, 122 million Americans (65.9% of the study population and 41.0% of the total US population) were estimated to be eligible to donate blood in the United States. Significant differences in eligibility rates by demographic characterizers were determined (p < 0.001): AAs (36.5%), whites (46.4%), and Hispanics (40.7%); males (45.4%) and females (42.7%); individuals 18 to 39 years old (35.8%); and individuals 40 to 69 years old (32.9%). CONCLUSIONS: AAs were significantly less eligible to donate blood than whites and Hispanics. Disparities in donor eligibility exist by race/ethnicity, sex, and age groups.     

Seasonal temperature variation and the rate of donor deferral for low hematocrit in the American Red Cross

BACKGROUND: Hematocrit (Hct) values in healthy adult populations exhibit seasonal variation, with the lowest values occurring in the summer. The extent to which environmental temperature contributes to the seasonal trend in deferral rates for unacceptable Hct in the American Red Cross was further analyzed. STUDY DESIGN AND METHODS: A centralized database of donations during 2002 to 2004, constituting 24.3 million donor presentations, was further characterized. Data on mean monthly temperature in the United States were obtained for the same period from a government agency. Multivariate regression analyses were performed to determine the relationship between Hct deferral rates among blood donors and environmental temperature and donor characteristics. RESULTS: Hct deferral rates were associated with mean monthly temperature in the United States (R(2) = 0.77). The relationship between the Hct deferral rate and environmental temperature was strongest in the region of the country with the highest seasonal variation in temperature, followed by regions with intermediate and low seasonal variation in temperature, respectively. The seasonal pattern in Hct deferral rates occurred in both sexes and across all age groups, with significantly higher Hct deferral rates occurring in June through August compared to other quarters (p < 0.0007). CONCLUSION: There is a significant seasonal pattern in Hct deferral rates that is associated with environmental temperature. The relationship between Hct deferral rates and temperature is strongest in areas of the country with greater temperature variability. The effect of seasonality on Hct deferrals should be taken into account for donor counseling, recruitment, and retention efforts.     

Prevalence of selected viral infections among temporarily deferred donors who returned to donate blood: American Red Cross blood donor study

BACKGROUND: Health history questions are introduced into the predonation interview to identify blood donors believed to pose a higher risk of infectious diseases to recipients. This study assesses the current impact of some of those questions. STUDY DESIGN AND METHODS: Donor deferral and donation data were extracted from a research database of the American Red Cross. The prevalence of hepatitis B surface antigen or antibodies to human immunodeficiency virus, hepatitis C virus, or human T-lymphotropic virus was obtained for different groups of donors who were temporarily deferred in 2000 through 2001 and later returned to donate blood in 2000 through 2003. The results were compared with either first-time or repeat donors in 2000 through 2003, while controlling for differences in sex, age, and year of donation. RESULTS: Of donors temporarily deferred in 2000 through 2001 who had had no donation or deferral during the previous 2 years, only 22.08 percent subsequently returned to donate blood in 2000 through 2003. Donations from returning donors who had been deferred for potential infectious disease risk did not show a higher prevalence for any of the viral markers when those with no donation or deferral during the previous two years were compared with first-time donations, and those with prior donation were compared with repeat donations. CONCLUSION: Blood donors temporarily deferred in 2000 through 2001 for potential risk of viral infection who later returned to donate blood did not appear to pose a higher risk compared to first-time or repeat donors. The effectiveness of some of the currently used deferral questions in reducing viral risks warrants further study.     

Donor deferral and resulting donor loss at the American Red Cross Blood Services, 2001 through 2006

BACKGROUND: A large number of blood donors are deferred each year and many of the temporarily deferred donors do not return to donate blood. This study analyzed actual deferral and return donation data from the American Red Cross to further assess the impact of donor deferral on donor availability. STUDY DESIGN AND METHODS: Voluntary blood donors who presented between 2001 and 2006 were included in this study. Deferred donors were classified into three groups according to their history of presentation during the prior 2 years: Group 1 with no prior donation or deferral, Group 2 with prior donation but no deferral, and Group 3 with prior deferral. Temporarily deferred donors in Groups 1 and 2 who did not return during the next 3 years were considered lost donors. All indefinitely deferred donors were lost donors. RESULTS: A mean of 12.8 percent of a total of 47,814,370 donor presentations between 2001 and 2006 resulted in a deferral. While majority of the deferrals were related to donor safety reasons, deferrals for recipient safety reasons accounted for 22.6 percent of deferrals or 2.9 percent of total presentations. Temporary and indefinite deferrals for recipient safety‐related reasons collectively caused an estimated loss of 647,828 donors during the 6 years. An additional 1,042,743 donors were lost due to deferrals for donor safety‐related reasons during the same period. CONCLUSIONS: The results on donor loss after deferral call attention to the impact of donor deferrals on donor availability and the need to monitor and assess the necessity and effectiveness of such deferrals.     

Immunogenetic blood markers as a risk factor of development of periodic disease in Armenian population

AIM: To reveal characteristic associations between various markers of immunogenetic (HLA--A, B, C, DR), erythrocytic (ABO, Rh-Hr, MNSs, Pp, Kell-Chellano, Lewis), serum (Gm, Inv) systems and familial Mediterranean fever (FMF) in Armenian population. MATERIAL AND METHODS: From 41 to 125 patients (depending on systems studied) were examined. HLA-antigens of A-, B-, C-classes were detected by the microcytotoxic test in a total population of lymphocytes, HLA-DR antigens--by a prolonged test in B-lymphocytes, erythrocytic antigens--by hemagglutination technique and indirect Coombs' reaction, serum antigens--by the method of hemagglutination suppression. RESULTS: Confidential positive associative relations between antigens HLA-A1 and A9 (RR = 2.2 and 2.4), HLA B5 and B35 (RR = 3.03 and 3.2), HLA-Cw4 (RR = 4.3), HLA-DR3 (RR = 2.6), phenotypes AB (RR = 2.86) and MN (RR = 2.2), serum antigen Gmx+ (RR = 2.87) were demonstrated. Simultaneous expression of phenotype MN and antigen Gmx+ is a marker of high predisposition to the disease (RR = 4.7). Negative associative relations were found between FMF and antigens HLA-B12 and B18 (RR = 0.6 and 0.1), HLA DR4 (RR = 0.1) and phenotype MM (RR = 0.37). CONCLUSION: A simultaneous complex investigation of the markers of various immunogenetic systems allows detection of genetic markers of predisposition to FMF (HLA-B5, B35, Cw4, DR3, AB, Gmx+, MN) and the resistance to this disease (HLA-B12, B18, DR4) in a population of Armenians.     

Regional and temporal variation in American Red Cross blood donations, 1995 to 2005

BACKGROUND: Maintaining a stable blood supply is a critical goal of the American Red Cross Blood Services. Extensive Red Cross data provided the opportunity to assess both long-term and short-term trends in the variation of weekly blood donations. STUDY DESIGN AND METHODS: Overall trends and week-to-week variation in donation rates were assessed in volunteer, whole-blood donations from 1995 to 2005 among three Red Cross donor regions: the Connecticut region, the Greater Chesapeake and Potomac (Maryland) region, and the Southern California region, adjusting for population change, calendar time, age, sex, and donor region. RESULTS: Weekly donation rates varied widely by region, ranging from 3.5 donations per 10,000 persons in Southern California to 10.2 donations per 10,000 in Connecticut. Week-to-week variation in donation rates within each region was also quite high. Typical swings in weekly donation rates ranged from 38 percent in Connecticut to 56 percent in Southern California. Week-to-week variation was also 103 percent higher (95% confidence interval [CI], 87%-120%) among 18- to 24-year-old donors, compared to 25- to 44-year-olds, ranging from 32 to 49 percent. By comparison, week-to-week variation among adults 25 and older was more stable, ranging from 16 to 21 percent. CONCLUSION: This study suggests that there is a great deal of variation in donation rates, particularly among the youngest donors. Improving recruitment and retention among these donors will be critical to maintaining an adequate blood supply as the donor population ages.     

Evaluation of blood supply operation and infectious disease markers in blood donors during the Egyptian revolution

BACKGROUND: The Egyptian revolution took place on January 25, 2011. Millions of protesters demanded the overthrow of the Egyptian president's regime. Many people suffered from life‐threatening injuries after violent clashes between police and protesters. STUDY DESIGN AND METHODS: The overall management of the blood bank operation at Cairo University Hospital was described, in an attempt to evaluate blood safety and establish a standard effective plan to manage blood supply during crisis. RESULTS: Three days after the uprising, thousands of Egyptians rushed to the hospital to alleviate the blood shortage. A total of 3425 units were collected in 3 days and thousands of donors were turned away. An error delayed processing of 1000 units and they were used as stored whole blood. Apheresis platelets were donated by protesters who were particularly motivated to donate for two victims with liver injury. The usual positive rate of hepatitis C virus (HCV) antibody in Egyptian donors is 3.8%. However, the positive rate of HCV markers in the collected units was only 1.6%. The mean age of donors during the revolution was 31.7 ± 10.4 years while the usual mean age of donors is 39.2 ± 8.5 years. Operating theaters were used only for emergencies. A blood surplus developed that met the hospital needs for 1 month. CONCLUSION: Revolution resulted in an influx of first‐time donors with a relatively low positive rate of HCV antibody. To be prepared for disasters, a systematic approach to spread donors evenly on a daily basis is needed.     

Current incidence and estimated residual risk of transfusion-transmitted infections in donations made to Canadian Blood Services

BACKGROUND: New testing methods such as nucleic acid amplification testing (NAT) and chemiluminescent serologic assays have been introduced, more precise estimates for infectious window periods are available, and a new method for estimating the residual risk (RR) of transfusion-transmitted infections (TTIs) has been developed. Thus, available RR estimates for Canada need to be updated. STUDY DESIGN AND METHODS: Incidence rates for known TTI markers were determined for all allogeneic whole-blood donations made to Canadian Blood Services between 2001 and 2005; they were derived from NAT conversions or seroconversions of repeat donors with at least two donations in a 3-year period. RR estimates for human immunodeficiency virus (HIV)-1 and hepatitis C virus (HCV) derived from the classical incidence/window-period model were compared to those obtained by the new method that estimates incidence from NAT-positive, antibody-negative donations (NAT-yield cases) from all donors divided by person-years. RESULTS: With the classical method, the RR of HIV (1 per 7.8 million donations) and HCV (1 per 2.3 million) were low; HBV RR was higher (1 per 153,000). HCV RR was significantly lower when estimated with the new method (1 per 13 million). Eleven HCV NAT-yield cases were predicted by applying the classical method to our seroconversion data but only 2 were observed (p = 0.011). Observed HIV-1 NAT-yield cases (n = 1) matched those predicted (n = 0.7). CONCLUSION: New tests have reduced an already low risk of TTI in Canada. HCV RR estimates by two different methods differed but both were low.     

Red blood cell alloimmunization in sickle cell disease: prevalence in 2010

BACKGROUND: Transfusion of red blood cells (RBCs) is frequently required for care of individuals with sickle cell disease (SCD). Alloimmunization rates are high and may be reduced by matching for RBC antigens that can cause alloimmunization. STUDY DESIGN AND METHODS: During the PROACTIVE Feasibility Study, patients with SCD age 2 years or older admitted for pain without acute chest syndrome were enrolled for possible randomization to preventive blood transfusion or standard care. Transfusion and antibody histories were obtained at each site, and antibody screening was done, to assess transfusion burden and alloimmunization prevalence. Participating sites were surveyed regarding antigen matching practice. RESULTS: A total of 237 patients (169 SS, 42 SC, 15 Sβ⁰‐thalassemia, 11 Sβ⁺‐thalassemia), 118 males and 119 females, were enrolled. Mean age was 19.3 years (range, 2.0‐68.0); there were 122 children and 115 adults. A total of 75.8% had received at least a single transfusion of RBCs before the study. Thirty‐four patients (14.4%) had a history of at least one alloantibody and 17 of these had more than one. When surveyed, 19 sites (83% of responders) reported antigen matching to at least include C, E, and K for transfusion of all patients with SCD. CONCLUSION: Though antigen typing before transfusion of people with SCD and providing antigen‐negative units is now widely employed by sickle cell centers, the alloimmunization rate remains quite high in contemporary sickle cell populations and may be due in large part to transfusions received at institutions not providing extended matching.     

Residual infectious disease risk in screened blood transfusion from a high-prevalence population: Santa Catarina, Brazil

BACKGROUND: Infectious disease testing has improved but viral infection transmission through transfusion continues to occur. Residual risk, however, is now so low in some countries that it can only be estimated by mathematical modeling. With hierarchical Bayesian methods, this study estimates the residual risk of transfusion-transmitted infections in Santa Catarina, Brazil. STUDY DESIGN AND METHODS: Data from the six state blood collection services covering Santa Catarina between 1998 and 2002 were used. Information was obtained on donor profiles, screening and confirmatory test results, and records of all allogeneic blood donations for repeat donors. Residual risk estimates of hepatitis B virus (HBV), human immunodeficiency virus (HIV), hepatitis C virus (HCV), and human T-cell leukemia virus (HTLV) were separately derived from posterior distributions of incidence rates and preseroconversion window-period lengths. RESULTS: Estimated risks of a donation infectious for HBV and HIV entering the blood supply are 1:10,700 (95% confidence interval [CI], 1:4900-1:28,200) and 1:26,200 (95% CI, 1:14,800-1:64,100) donations, respectively. Estimated risks for HCV and HTLV were 1:19,300 (95% CI, 1:10,400-1:44,800) and 1:116,300 (95% CI, 1:40,200-1:1,000,000) donations, respectively. HBV risk is 1.8 times greater than HCV risk, 2.4 times greater than HIV risk, and 10.8 times that of HTLV. Actual risks would be lower due to immune recipients and subinfectious levels of undetected viremia. CONCLUSION: The major factor contributing to risk differences between Santa Catarina and countries with similar testing regimes is the much higher source population diseases prevalence. Payoff for nucleic acid testing would be low, thus additional investment in safety should be based on studies of the cost-effectiveness of different strategies to reduce overall transmission.     

Syncope in an elderly, institutionalised population: prevalence, incidence, and associated risk

Although syncope is common in the elderly, little is known of its epidemiology and prognosis. A retrospective analysis of syncope in 711 very old (mean age 87 years) institutionalised patients revealed a 10 year prevalence of 23 per cent and one year incidence of 7 per cent. A two-year prospective follow-up of this population revealed a yearly incidence of 6 per cent and recurrence rate of 30 per cent. Of 67 patients who developed syncope during follow-up, a cause was established in 46; 14 (21 per cent) had cardiac and 32 (48 per cent) had non-cardiac aetiologies. Twenty-one cases (31 per cent) remained unexplained. Patients who developed syncope were initially more functionally disabled (p = 0.003) and subsequently changed function more frequently (p = 0.03) than those without the development of syncope, but two year rates of hospitalisation and death were not different between the two groups. Life-table survival analysis showed no difference in the mortality of subgroups with cardiac, non-cardiac, and unknown aetiologies of syncope. Syncope is common in multiply impaired elders and is likely a manifestation of co-morbid disease rather than an independent contributor to mortality.     

Number of recent sexual partners among blood donors in Brazil: associations with donor demographics, donation characteristics, and infectious disease markers

BACKGROUND: Brazilian blood centers ask candidate blood donors about the number of sexual partners in the past 12 months. Candidates who report a number over the limit are deferred. We studied the implications of this practice on blood safety. STUDY DESIGN AND METHODS: We analyzed demographic characteristics, number of heterosexual partners, and disease marker rates among 689,868 donations from three Brazilian centers between July 2007 and December 2009. Donors were grouped based on maximum number of partners allowed in the past 12 months for each center. Chi‐square and logistic regression analysis were conducted to examine associations between demographic characteristics, number of sex partners, and individual and overall positive markers rates for human immunodeficiency virus (HIV), human T‐lymphotropic virus Types 1 and 2, hepatitis B virus, hepatitis C virus, and syphilis. RESULTS: First‐time, younger, and more educated donors were associated with a higher number of recent sexual partners, as was male sex in São Paulo and Recife (p < 0.001). Serologic markers for HIV and syphilis and overall were associated with multiple partners in São Paulo and Recife (p < 0.001), but not in Belo Horizonte (p = 0.05, p = 0.94, and p = 0.75, respectively). In logistic regression analysis, number of recent sexual partners was associated with positive serologic markers (adjusted odds ratio [AOR], 1.2‐1.5), especially HIV (AOR, 1.9‐4.4). CONCLUSIONS: Number of recent heterosexual partners was associated with HIV positivity and overall rates of serologic markers of sexually transmitted infections. The association was not consistent across centers, making it difficult to define the best cutoff value. These findings suggest the use of recent heterosexual contacts as a potentially important deferral criterion to improve blood safety in Brazil.