Structuring a safer donor-replacement program

BACKGROUND: Replacement donors are more likely than volunteer donors to have positive or abnormal tests for transfusion-transmissible disease. In an effort to increase the donor pool, workers sought to identify a safer replacement-donor subgroup that may be acceptable for routine donations. STUDY DESIGN AND METHODS: In a retrospective review and cohort study, the replacement-donor effect was separated from the new- donor effect. The relative effect the replacement donor has on the risk of transfusion-transmissible diseases, donor retention, and frequency of returning donations was then quantified by comparison against the effect of repeat volunteer donors. RESULTS: The replacement donor had 3.1 times the risk and 0.72 times the donor retention rate and made 0.81 times as many returning donations as the repeat volunteer donor. The figures for the new-donor effect were similar. The two risks were additive, making a new replacement donor particularly hazardous. If replacement donations only from repeat replacement donors were considered, the donor risk and the number of donations per returning donor were made comparable to those for the general (combined) volunteer donor. CONCLUSION: The negative effect of the replacement donor is similar in magnitude to that of the new volunteer donor. A replacement-donation program targeting repeat replacement donors has an acceptable risk profile and may be a valuable adjunct to the collection of blood from general volunteer donors.     

Predonation screening of blood donors with rapid tests: implementation and efficacy of a novel approach to blood safety in resource-poor settings

BACKGROUND: In sub-Saharan Africa, the percentage of screened blood is limited to approximately 75 percent for human immunodeficiency virus antibodies (anti-HIV), 50 percent for hepatitis B surface antigen, and 19 percent for hepatitis C virus antibodies (anti-HCV), mainly because of costs. STUDY DESIGN AND METHODS: In 2002 to 2003, candidate blood donors were screened before donation for HIV, HCV, and hepatitis B virus (HBV) serologic markers with rapid tests. The efficacy of this screening was assessed by nucleic acid testing (NAT) applied to pools of 10 plasma samples from donated units with a virus specific triplex assay. NAT-reactive pools were resolved by viral genome identification in individual plasma sample. Deferred candidate donors were referred to a donor-care program. RESULTS: A total of 9372 people were screened and 1534 (16.4%) were deferred. No HIV or HCV RNA-containing samples remained undetected by rapid tests unless a human testing error was involved. In contrast, 1.3 and 3.0 percent of HBV DNA-containing blood units were negative with rapid tests but were detected in individual donations with enzyme immunoassay and genomic amplification, respectively. Only half of these units were detectable in pools of 10 samples. One-third of deferred candidate donors attended the donor-care program and were informed and counseled. CONCLUSIONS: Predonation viral screening of blood donors is effective in high endemic areas, and the savings it generates may improve the safety and limit the cost of blood. Communication with deferred donors may contribute to public health. A new screening strategy associating serologic rapid test before donation and NAT on pools of 10 plasma samples after donation is proposed.     

Relative safety of first‐time volunteer and replacement donors in West Africa

BACKGROUND: A significantly higher level of safety between nonremunerated volunteer and replacement donor blood is assumed. This is supported by global data without stratifying between genuine replacement and paid donors, for first‐time or repeat volunteer, or according to age. STUDY DESIGN AND METHODS: In 2008, first‐time volunteer and replacement donors were identified, and confirmed human immunodeficiency virus antibody (anti‐HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (anti‐HCV)‐positive screening results were collated. Data were analyzed according to age and sex between the two types of donors. RESULTS: In 6640 first‐time volunteer and 4360 replacement donors, the prevalence of anti‐HIV and HBsAg (1.03 and 13.8% vs. 1.1 and 14.9%, respectively) was not significantly different. Anti‐HIV prevalence was higher in replacement donors less than age 20 than in first‐time volunteers; the difference was not significant. HBsAg and anti‐HIV confirmed‐positive prevalence was significantly higher in first‐time volunteer donors over age 20. CONCLUSION: In Kumasi, Ghana, viral safety of replacement and first‐time volunteer donors was similar, constituting a single population of donors. Safety increment is provided by repeat donation applicable to either group, through different approaches. A blood unit from replacement donor costs half or less than that from a volunteer donor; similar studies conducted elsewhere in sub‐Saharan Africa may lead to changes in current strategies.     

Prevalence of viral markers among first-time Arab blood donors in Kuwait

BACKGROUND: The aim of this study was to assess the effect of blood donation modes on the prevalence of viral markers among Arab first-time blood donors in Kuwait. STUDY DESIGN AND METHODS: Donor ethnic background was classified as Kuwaiti nationals and non-Kuwaiti Arabs. A total of 26,874 donors were screened in 2002 for the following viral markers: hepatitis C virus antibody (anti-HCV), hepatitis B surface antigen (HBsAg), anti-hepatitis B core antigen (HBc), human immunodeficiency virus-1 and -2 antibody (anti-HIV-1 and -2), HIV p24, and human T lymphotropic virus-I and -II antibody (anti-HTLVI/II). All samples positive for the presence of anti-HBc were tested for anti-HBs. Among these donors, 12,798 were first-time donors of which 74 percent were replacement and 26 percent were volunteers. RESULTS: The prevalence of HCV among replacement donors was significantly higher than the volunteer group. The difference between the two modes of blood donations, however, was not significant for HBsAg. The prevalence of anti-HCV among Kuwaiti national and non-Kuwaiti Arab first-time donors was 0.8 and 5.4 percent, respectively, whereas the prevalence of HBsAg was 1.1 and 3.5 percent, respectively, with the difference being significant at a p level of <0.0001. The difference observed for prevalence of anti-HBc among Kuwaiti national and non-Kuwaiti Arab donors (17 and 33.3%, respectively) was significant (p < 0.0001). Among first-time donors, 13.7 percent were positive for the presence of anti-HBs, indicating that 13.7 percent of the total Arab donor population might have had a previous infection and possible immunity to hepatitis B virus (HBV). CONCLUSION: A high prevalence of HBV and HCV was found among non-Kuwaiti Arab donors. The prevalence of anti-HCV was only significantly higher among replacement versus volunteer first-time donors. Therefore, there is a need to develop a strategic plan that incorporates the diverse background of the blood donors living in Kuwait.     

Changing age distribution of the blood donor population in the United States

BACKGROUND: The American Red Cross has been maintaining a research database of all blood donors. Such a database provides a unique opportunity for monitoring changes over time in donor and donation patterns. STUDY DESIGN AND METHODS: Changes in age distribution among blood donors were analyzed through comparison of the volunteer donor population in 1996, 1999, 2002, and 2005, before and after adjustment for demographic changes of the general population in the United States. RESULTS: Donations by repeat donors 50 years or older as a proportion of total donations increased from 22.1 percent in 1996 to 34.5 percent in 2005, or 1.4 percent per year, whereas donations from repeat donors of 25 to 49 years decreased from 49.1 percent in 1996 to 37.1 percent in 2005, or 1.3 percent per year. After adjusting for general population trends, the effective number of donors decreased by more than 10 percent in female and male repeat donors of age 20 to 49 years and male first-time donors of age 25 to 49 years from 1996 to 2005; female and male repeat donors of age 25 to 39 years decreased by greater than 40 percent. Prevalence rates of major infectious disease markers decreased by 3.3 percent or more per year for first-time donations and by 6.4 percent or more per year for repeat donations. CONCLUSION: The aging patterns of blood donors suggest the need for improved recruitment and retention in the young adult and middle-aged groups. A severe shortage of blood and blood components may be forecast in the foreseeable future unless offset by significant increased supply or reduced usage of blood and blood components.     

互助献血与无偿献血血清学标志物对比分析

目的：对互助献血和无偿献血的血清学指标进行分析对比,研究探讨互助献血的风险。方法2006年1月至2012年12月,对符合献血条件的1834例互助献血者以及217323例无偿献血者进行了血液采集和留取 ETDA 抗凝样本,进行 ALT、HBsAg、Anti-HCV、Anti-HIV、梅毒共5个项目的初复检。结果互助献血（8.67％）的总阳性率要高于无偿献血组（6.31％）,但两组的ALT 阳性率差异无统计学意义,互助献血组的HBsAg、Anti-HCV、梅毒均高于无偿献血组。结论无偿献血群体的血清学安全指标优于互助献血组,是血源性传播疾病较低的低危人群,应该是血液供应的主要来源群体;对互助献血采取合理的干预措施后,能确保其安全指数与无偿献血等同,可作为无偿献血的有益补充。     

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.     

A comparison of human immunodeficiency virus,hepatitis C virus,hepatitis B virus,and human T‐lymphotropic virus marker rates for directed versus volunteer blood donations to the American Red Cross during 2005 to 2010

BACKGROUND: At most US blood centers, patients may still opt to choose specific donors to give blood for their anticipated transfusion needs. However, there is little evidence of improved safety with directed donation when compared to volunteer donation. STUDY DESIGN AND METHODS: The percentage of directed donations made to the American Red Cross (ARC) from 1995 to 2010 was determined. Infectious disease marker rates for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and human T‐lymphotropic virus (HTLV) were calculated for volunteer and directed donations made from 2005 to 2010. Odds ratios (ORs) were calculated to compare marker‐positive rates of directed donations to volunteer donations. RESULTS: The percentage of donations from directed donors declined from 1.6% in 1995 to 0.12% in 2010. From 2005 to 2010, the ARC collected 38,894,782 volunteer and 69,869 directed donations. Rates of HIV, HCV, HBV, and HTLV for volunteer donations were 2.9, 32.2, 12.4, and 2.5 per 100,000 donations, respectively; for directed, the rates were 7.2, 93.0, 40.1, and 18.6 per 100,000. After demographics and first‐time or repeat status were adjusted for, corresponding ORs of viral marker positivity in directed versus volunteer donations were not significant for HIV, HBV, or HTLV and significant for HCV (OR, 0.7; 95% confidence interval, 0.50‐0.90). CONCLUSIONS: Directed donations have declined by 92% at the ARC since 1995, but have higher viral marker rates than volunteer donations. The difference can be explained in part by the effects of first‐time or repeat status of the donors. Patients considering directed donation should be appropriately counseled about the potential risks.     

Directed-donor programs may adversely affect autologous donor participation

One hundred autologous whole blood donors (11 men, 89 women; 49 preoperative, 51 prenatal) completed a questionnaire concerning their motivations as autologous donors, their perceptions of the relative safety of blood donor options, and their interest in directed donations. Concern about acquiring AIDS from transfusion was the most prevalent reason for autologous donation. Nearly all participants knew that autologous blood was safer than volunteer blood, and most also believed that directed-donor blood was safer than volunteer blood. Most would have used a directed-donor program if available, particularly if they were ineligible as autologous donors. Furthermore, their interest in directed donations was unaffected by written material, provided pathway through the questionnaire, that included a statement that no scientific evidence exists to support directed donations' being safer than volunteer blood. One donor in five believed that autologous and directed donations were equivalent in safety, and 19 (15 of whom were prenatal donors) indicated that they probably or surely would not have participated in the autologous program if directed donations had been available. This study demonstrates that a sizable proportion of autologous donor candidates might not participate if a directed donation program were available. The unrestricted availability of directed donations may thus contribute to suboptimal use of autologous donor programs.     

Who donates blood at five ethnically and geographically diverse blood centers in China in 2008

BACKGROUND: In China recruitment and retention of sufficient numbers of safe blood donors continues to be a challenge. Understanding who donates blood, particularly those who donate larger (>200 mL) whole blood (WB) units, will help blood centers to target more effective recruitment and retention strategies. STUDY DESIGN AND METHODS: Demographic characteristics of 226,489 allogeneic WB donors from January to December 2008 at five geographically and ethnically diverse, urban blood centers were analyzed. RESULTS: The typical Chinese WB donor can be characterized as first‐time volunteer (67.9%), male (56.9%), less than 45 years old (93.8%), and Han ethnicity (86.1%). Most donors had some college or below educational level (77.5%), donated at a mobile collection site (97.6%), and donated 300‐ or 400‐mL units (76.0%). Differences in WB volume donations and donor demographics exist among the five centers. CONCLUSION: In China compared to the United States, donations are made by younger donors and donors give infrequently and make smaller WB donations. To help ensure supply adequacy, continued efforts are needed to have donors give larger volumes of WB in China.     

Influences of general and traditional Chinese beliefs on the decision to donate blood among employer-organized and volunteer donors in Beijing, China

BACKGROUND: For the past several decades, Chinese blood centers have relied on blood donations from employer-organized donors (blood donors who donate blood in groups with coworkers as prearranged by the employer and the local blood center). Recently the government has decided to phase out employer-organized donors and transition to the use of only volunteer donors (blood donors who donate individually independent of employers). Evaluating the beliefs and attitudes of employer-organized and volunteer donors is critical to maintain an adequate blood supply after this transition. STUDY DESIGN AND METHODS: The study population consisted of 431 volunteer donors and 527 employer-organized donors who completed a structured questionnaire in July 2005. RESULTS: Employer-organized donors tended to be older, male, and married, with higher education and higher income compared to volunteer donors. Volunteer donors were more often motivated by altruism (p < 0.001) and more likely to donate larger volumes (400 mL vs. 200 mL) of blood (volunteer 70.5% vs. employer-organized 7%; p < 0.001). Employer-organized donors were more inhibited by factors related to traditional Chinese beliefs, such as the belief that blood donation affects life energy "Qi" (volunteer 3.1% vs. employer-organized 12.7%; p < 0.001), and requested more time off from work after donating. Employer-organized donors also express a greater concern about contracting disease from donating blood. CONCLUSION: To recruit voluntary donors effectively in China and other countries with traditional cultures, efforts need to counteract traditional beliefs and perceptions of risk that discourage donation by emphasizing the benefits, safety mechanisms, physiology, and epidemiology of blood donation. In China, there is a rich opportunity to convert prior employer-organized donors into volunteer donors, and the institution of a confidential predonation screening system may help to facilitate truthful risk factor disclosure.     

Residual risk of transfusion-transmitted HCV and HIV infections by antibody-screened blood in Italy

BACKGROUND: This study was designed to assess the risk of transmitting HCV and HIV by transfusion of antibody-screened blood and to estimate the additional reduction in risk that may be achieved through the implementation of direct viral detection assays in Italy. STUDY DESIGN AND METHODS: Clinical and laboratory data of 2,411,800 blood donations collected from repeat volunteer donors from 1996 through 2000 were analyzed. The risk of transmitting HCV or HIV from screened blood donated during the window period was estimated using a mathematical model. RESULTS: The residual risk of donating antibody-negative infectious blood was estimated at 1 in 127,000 donations for HCV and 1 in 435,000 for HIV. The use of NAT should further reduce such risk by 83 percent for HCV and 50 percent for HIV. CONCLUSION: The residual risk of HCV or HIV transmission through screened blood is currently very small in Italy. The implementation of direct viral detection assays can further improve the safety of blood supply.     

Increased risk of a positive test for antibody to hepatitis B core antigen (anti-HBC) in autologous blood donors

Controversy exists about the suitability of blood from autologous donors for homologous use. We compared the infectious disease test results of 426 autologous donors, designated by donor history as suitable for homologous use, to those of 86,138 volunteer donations collected over the same 5 month period. Although donor characteristics differed, the relative risk of a positive test for anti-HBc in the autologous group was 2.09. When 413 autologous donors were compared to 413 volunteer donors matched for age, sex, and zip code, the relative risk of a positive test for anti-HBc in the autologous group was 3.2. If anti-HBc is a marker for non-A, non-B hepatitis transmissibility, then our autologous group is not as safe as our volunteer donors. We recommend that autologous blood, even when designated by donor history and laboratory screening results as suitable for homologous transfusion, not be used for other than the intended autologous recipient.     

Temporal trends in the prevalence of HIV and other transfusion-transmissible infections among blood donors in northern Thailand, 1990 through 2001

BACKGROUND: Thailand's epidemic of HIV infection, which began in 1988, has primarily involved heterosexual transmission of the virus. This study describes changes in prevalence of HIV and other infectious diseases among blood donors in northern Thailand from 1990 through 2001. STUDY DESIGN AND METHODS: Serologic screening results and demographic data were analyzed from 276,066 donors screened at two blood collection facilities in Chiang Mai, Thailand, from 1990 through 2001. RESULTS: The HIV prevalence peaked in 1991 to 1993 at 4.04 percent and then declined to 0.38 percent in 2001. The overall prevalence of HIV infection was 2.16 percent; HIV prevalence was higher among male (2.24%) than among female (0.64%) donors, in first-time donors, and in replacement volunteer donors. The majority of the donors were men and first-time donors throughout this study. The prevalence of antibodies to syphilis decreased significantly in both men and women. However, the prevalence of antibodies to HCV and HBsAg were stable. CONCLUSIONS: The declining HIV prevalence from 1990 through 2001 among blood donors in two large blood banks in northern Thailand indicates significant progress toward recruitment of a safer donor population in a developing country despite a major HIV and AIDS epidemic involving the general population.     

Increasing blood availability by changing donation patterns

BACKGROUND: There is a declining margin between US blood collections and transfusions. Donation patterns were examined to characterize returning first-time donors and predict the impact on blood availability of decreasing the number of nonreturning donors. STUDY DESIGN AND METHODS: First-time donors giving between 1991 and 1994 were followed for 3 to 6 years. The impact of decreasing the number of nonreturning donors in a 12-month period was projected using the Poisson distribution to model the donation patterns of 539,063 donors who gave in 1995. Repeat donors were classified as "returning first-time" (gave a first-time donation within 12 months of their index donation), "established" (gave a repeat donation), and "inactive" (didn't donate in the 12 months before their index donation). RESULTS: A total of 49 percent of first-time donors did not return within 6 years. Returning first-time donors tended to be US born, white, and had more than a high school education. In 1995, 30 percent of donors were first time, 31 percent were established, 7 percent were returning first time, and 32 percent were inactive, giving 1.5, 2.4, 1.9, and 1.7 donations in 12 months, respectively. Reducing nonreturning donors by 5 percent could increase blood collections by 2.7 percent. Similarly, 15 or 25 percent reductions in nonreturns could increase collections by 8.6 or 16.0 percent, respectively. CONCLUSIONS: Most donors are not giving near the donation limit. A substantial increase in donations could be achieved by a relatively small decrease in donor nonreturn. Research is needed to understand why approximately half of first-time donors donate only once.     

Deferred donor care in a regional hospital blood center in Ghana

BACKGROUND: In sub-Saharan Africa, the viral marker burden in blood donor populations ranges between 10 and 30 percent. Deferred donors constitute a rare population of asymptomatic human immunodeficiency virus (HIV)- and hepatitis B virus (HBV)-infected individuals with high likelihood of long survival if cared for. Deferred donor care provides an opportunity for a public health impact on highly pathogenic infections.
STUDY DESIGN AND METHODS: Between 2004 and 2007, all candidate donors deferred before donation for reactivity of anti-HIV, hepatitis C virus antibody (anti-HCV), and hepatitis B virus surface antigen (HBsAg) rapid tests were informed and referred to a donor care program consisting of test confirmation, information, counseling, and potential referral for follow-up and therapy. Dedicated trained nurses supervised the program including alanine aminotransferase (ALT) level testing to identify liver disease.
RESULTS: In a 4-year period 51,100 donors were screened and 5778, 1578, and 227 candidate donors were deferred for reactivity to HBV, HIV, or HCV serologic markers, respectively. The rates of entry into the donor care program were 48, 14.3, and 22 percent of deferred donors, respectively. A total of 83 of 210 HBsAg-positive donors with elevated ALT levels were referred and 66 received antiviral treatment. A total of 89 of 516 confirmed anti-HIV–positive donors were referred to the hospital acquired immune deficiency syndrome clinic for follow-up.
CONCLUSIONS: With little additional expense, the deferred donor care program identified asymptomatic infections with high odds of benefiting from monitoring and therapy. In the local circumstances, this public health–limited but definite impact was permitted by the rapid-test predonation screening, and this impact could be increased if more resources were available.     

Short-term ferrous sulfate supplementation in female blood donors

BACKGROUND: Iron deficiency is a public problem in women, which contributes to the high percentage of deferred blood donations in this group. This study evaluated the effect of iron supplementation in improving iron stores to promote safe blood donation in women. STUDY DESIGN AND METHODS: A total of 412 female blood donors were randomly recruited for the study. The volunteers were scheduled for an initial visit and three subsequent visits at 4-month intervals for possible repeat donation. Each volunteer was given 21 tablets of 150 mg of ferrous sulfate or placebo to be taken three times daily for 1 week after each blood donation. Their hemoglobin (Hb) concentration, hematocrit (Hct), serum ferritin, total iron-binding capacity (TIBC), and percent saturation of the TIBC were tested throughout the course of the study. RESULTS: The group taking ferrous sulfate showed no significant difference between the mean initial and final result for any of the values other than Hb values, whereas there was a significant decline in mean Hb, Hct, serum iron, serum ferritin, and percent saturation in the group taking placebo. Hb concentrations declined significantly in both groups; however, it was more severe in the placebo group when compared to the ferrous sulfate group. The relative risk of iron deficiency in placebo group was 3.6 (95% confidence interval = 1.73-7.74). CONCLUSION: The results indicate that supplementation therapy can be considered as one of the strategies to promote safe blood donation in women. A quantity of 150 mg of elemental iron per day as ferrous sulfate, however, is not the correct dose for Iranian female donors.     

A randomized crossover trial of IV fluid replacement versus no fluid replacement in autologous blood donors with cardiovascular disease

BACKGROUND: The aim of this study was to compare the incidence of arterial hypotension in response to autologous blood donation with and without simultaneous IV fluid replacement in 60 patients with cardiovascular disease. STUDY DESIGN AND METHODS: Each patient donated two 500 mL units of blood at an interval of 7 days. Following random allocation within a two-stage crossover design, either the first or second unit was collected with a simultaneous IV infusion of 500 mL of HES. Patients receiving IV fluid replacement during their first donation did not receive any fluid replacement during their second donation and vice versa. Starting before phlebotomy, arterial blood pressure was measured oscillometrically every 5 minutes until 30 minutes after donation. Hypotension was defined as at least one decrease of more than 20 percent from baseline in systolic blood pressure. RESULTS: A decrease of more than 20 percent from baseline in systolic blood pressure occurred in 2 of the 60 patients (3%) during the donations with IV fluid replacement compared with 55 of the 60 patients (92%) during the donations without IV fluid replacement (p < 0.0001, McNemar's test). No severe reaction to blood donation was observed in any patient, regardless of whether IV fluids had been administered. CONCLUSION: Isovolemic IV fluid replacement was useful in preventing arterial hypotension in autologous blood donors with cardiovascular disease. Its effect on the safety of the autologous blood donation process remains to be established.