The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention.

BACKGROUND AND OBJECTIVES: Repeated blood donation produces iron deficiency. Changes in dietary iron intake do not prevent donation-induced iron deficiency. Prolonging the interdonation interval or using oral iron supplements can mitigate donation-induced iron deficiency. The most effective operational methods for reducing iron deficiency in donors are unknown. MATERIALS AND METHODS: 'Strategies To Reduce Iron Deficiency' (STRIDE) was a two-year, randomized, placebo-controlled study in blood donors. 692 donors were randomized into one of two educational groups or one of three interventional groups. Donors randomized to educational groups either received letters thanking them for donating, or, suggesting iron supplements or delayed donation if they had low ferritin. Donors randomized to interventional groups either received placebo, 19-mg or 38-mg iron pills. RESULTS: Iron deficient erythropoiesis was present in 52·7% of males and 74·6% of females at enrolment. Adverse events within 60 days of enrolment were primarily mild gastrointestinal symptoms (64%). The incidence of de-enrolment within 60 days was more common in the interventional groups than in the educational groups (P = 0·002), but not more common in those receiving iron than placebo (P = 0·68). CONCLUSION: The prevalence of iron deficient erythropoiesis in donors enrolled in the STRIDE study is comparable to previously described cohorts of regular blood donors. De-enrolment within 60 days was higher for donors receiving tablets, although no more common in donors receiving iron than placebo.

Seroprevalence of known and putative hepatitis markers in United States blood donors with ALT levels at least 120 IU per L.

BACKGROUND: ALT testing of blood donors was initiated as a surrogate marker for non-A, non-B hepatitis. Increased sensitivity of subsequent HBV and HCV tests used for standard donor screening make any residual value of ALT testing questionable. STUDY DESIGN AND METHODS: A prospective study was conducted in 166 of 645 eligible blood donors from three American Red Cross regions whose ALT was > or =120 IU per L and whose standard donor screening tests were negative. Of these enrolled donors, 124 (75%) completed follow-up. Samples obtained from the index donation, at enrollment (1 month), and at follow-up (6 months) underwent the standard donor screening tests, as well as those for HCV RNA and HGV RNA (RT-PCR), antibodies to the virus envelope E2 protein of GB virus type C (GBV-C E2 antibody), and IgM antibody for CMV, parvovirus B19, EBV VCA, and HAV. Participants completed a brief demographic and exposure history questionnaire at follow-up. RESULTS: All study samples were negative in standard donor-screening tests. ALT levels were variable at return visits, with 80 to 86 percent <120 IU per L. No participants were positive for HCV RNA; 4 percent were positive for HGV RNA, and 10 percent were positive for GBV-C E2 antibody. Results of CMV, parvovirus B19, EBV VCA, and HAV testing were similar to published background rates. No demographic or exposure history variables had significant correlation with ALT or other testing results. CONCLUSION: These data suggest that an ALT > or =120 IU per L in blood donors with negative standard screening tests has questionable value as a surrogate marker for seronegative HBV or HCV infection. Continued ALT testing may contribute little, if anything, to the safety of blood components or plasma for further manufacture.

Babesiosis in a renal transplant recipient acquired through blood transfusion.

BACKGROUND: The success of organ-replacement therapies has resulted in a population of chronically immunosuppressed but active people who experience increased vulnerability to tick-borne zoonoses. Several of these infections may be life threatening. Human babesiosis is an emerging zoonosis that is transmitted by the same tick that transmits Lyme disease and human granulocytic ehrlichiosis. METHODS: We briefly review these zoonoses and present a case of a renal transplant recipient who survived infection by Babesia microti contracted through blood transfusion. RESULTS: A recipient of a living-related renal transplant developed acute postoperative hemolytic anemia. The etiology of this anemia was diagnosed by peripheral red blood cell smear as Babesia microti. The patient was managed by a reduction in transplant immunosuppressive therapy and administration of clindamycin and quinine antimicrobials. CONCLUSIONS: Transplant patients may contract babesiosis after tick exposure and/or via blood transfusion. The diagnosis of babesiosis may be confused with malaria and should be included in the differential diagnosis of posttransplant hemolytic-uremic syndrome in organ transplant patients.

A case-controlled multicenter study of vasovagal reactions in blood donors: influence of sex, age, donation status, weight, blood pressure, and pulse.

BACKGROUND: Vasovagal reactions occur in a small, but significant number of blood donors. These reactions may decrease return donation and disrupt blood collection activities. The purpose of this study was to define the contributory role of sex, age, weight, blood pressure, and pulse in vasovagal reactions with syncope in blood donors. STUDY DESIGN AND METHODS: A retrospective case-control study involved 1890 blood donors with syncope from three large United States blood centers during 1994 and 1995. Case controls and random population controls were used in a logistic regression analysis to determine the significance of individual variables to syncopal reactions. RESULTS: Female donors, young donors, first-time donors, low-weight donors, and donors with low predonation blood pressure had higher absolute donation reaction rates than other donors. When each variable was adjusted for other variables by regression analysis, age, weight, and donation status (first-time or repeat donor) were significant (p<0.0001), and sex, predonation blood pressure, and predonation pulse were not. The most important variables, in descending order, were age, weight, and donation status (first-time or repeat donor). CONCLUSIONS: Donation-related vasovagal syncopal reactions are a multifactorial process determined largely by age, weight, and first-time donor status.

Predictive value of past and current screening tests for syphilis in blood donors: changing from a rapid plasma reagin test to an automated specific treponemal test for screening.

BACKGROUND: This study evaluated the change from a rapid plasma reagin (RPR) test to an automated specific treponemal test (PK-TP) in screening for syphilis in blood donors. STUDY DESIGN AND METHODS: A cross-sectional seroprevalence analysis was performed on 4,878,215 allogeneic blood donations from 19 American Red Cross Blood Services regions from May 1993 through September 1995. Positive predictive values relative to the confirmatory fluorescent treponemal antibody absorption test (FTA-ABS) were calculated. Differences in seroprevalence were compared in RPR and PK-TP tests for 1) unconfirmed and confirmed tests, 2) first-time and repeat donors, and 3) "recent" versus "past" infections. Donation data from three additional Red Cross regions were evaluated for repeat donation patterns of blood donors who had a donation that was positive in a serologic screening test for syphilis. The value of RPR and PK-TP tests as surrogate markers for HIV infection was compared. RESULTS: Reactive rates were lower but the positive predictive values was higher for the PK-TP test than for the RPR test. Initially, donors screened by PK-TP were more likely to be confirmed as positive than were donors screened by RPR, but these rates became comparable. It is estimated that a single HIV window-period donation was removed by serologic testing for syphilis each year of this study period. CONCLUSIONS: The change to the PK-TP test resulted in a lower repeatedly reactive rate, better prediction that a confirmed-positive test for syphilis would occur in testing in the FTA-ABS, fewer donations lost, and comparable deferral rates. Because of the high rate of reactivity to serologic testing for syphilis among donors previously confirmed positive for syphilis, indefinite deferral after a confirmed-positive index donation may be warranted. Serologic testing for syphilis is ineffective as a marker of HIV-infectious window-period donations.

A comprehensive transfusion medicine curriculum for medical students. Transfusion Medicine Academic Award Group.

BACKGROUND: The Transfusion Medicine Academic Awards (TMAA) program, sponsored by the National Heart, Lung, and Blood Institute, has provided grants to medical schools to help them develop comprehensive curricula in transfusion medicine. In 1989, the TMAA Group published a set of comprehensive curricular goals for teaching transfusion medicine. The medical student portion of this curriculum has now been revised to reflect new developments in transfusion medicine and recent trends in medical school education. STUDY DESIGN AND METHODS: Two medical schools independently revised the 1989 curriculum for their students. Because significant similarities were noted between curricula of the two institutions, the two revisions were combined and submitted to all TMAA institutions for comment. As a result, a revised medical school curriculum was developed and approved by the TMAA Group. RESULTS: The revised curriculum consists of 28 objectives in six major areas of transfusion medicine. It is presented in its entirety in this article. CONCLUSION: The TMAA transfusion medicine curriculum should provide to medical schools a valuable resource for evaluating their teaching of transfusion medicine and should provide to medical school deans and curriculum committees an authoritative source of transfusion medicine expertise.

The risk of acquiring Lyme disease or babesiosis from a blood transfusion.

To determine the risk of acquiring Lyme disease or babesiosis from blood transfusion, serum was collected before and 6 weeks after patients received multiple transfusions during cardiothoracic surgery and antibodies to Borrelia burgdorferi and Babesia microti were measured. Of 155 subjects, 149 received 601 total units of packed red blood cells (PRBC) and 48 received 371 total units of platelets. No patient developed clinical or serologic evidence of Lyme disease; 1 (who received 5 units of PRBC) developed clinical and serologic evidence of babesiosis. The risk of acquiring Lyme disease from a transfused unit of PRBC was 0 (95% confidence interval [CI], 0-0.5%) and from a transfused unit of platelets was 0 (95% CI, 0-0.8%); the same risks for babesiosis were 0.17% (95% CI, 0.004%-0.9%) and 0 (95% CI, 0-0.8%), respectively. The risk of acquiring either Lyme disease or babesiosis from a blood transfusion in Connecticut is very low.

Adoptive immunotherapy with peripheral blood lymphocytes cocultured in vitro with autologous tumor cells and interleukin-2.

A clinical trial of adoptive immunotherapy was carried out with peripheral blood lymphocytes (PBL), cocultured in vitro with autologous tumor cells and interleukin-2 (IL-2), in 14 patients with advanced melanoma. PBL from these patients were cocultured with irradiated autologous tumor cells for 7 days, which was followed by expansion in IL-2-containing medium. These lymphocytes were returned to the patient along with intravenous IL-2 at doses up to 2 x 10(6) IU m-2 day-1. A dose of 300 mg/m2 cyclophosphamide was administered to each patient intravenously 4 days prior to each treatment. Following coculture, the lymphocytes were primarily CD3+ T cells and they expressed varied degrees of cytotoxicity against autologous melanoma cells. In 9 patients the activated cells were at least 80% CD4+ and in 2 cases they were mostly CD8+. Some of the activated cells exhibited suppressor or helper activity in a functional regulatory coculture assay. No major therapeutic response was observed in this study. Minor responses were observed in 2 patients. Toxicities were those expected from the IL-2 dose administered.

The effect of solvent/detergent-treated plasma on stored platelet concentrates.

The treatment of fresh-frozen plasma (FFP) with a solvent/detergent (S/D) solution to inactivate contaminating viruses has been shown to be effective in reducing virus transmission while maintaining the hemostatic properties of the plasma. FFP is treated with tri(n-butyl)phosphate (solvent) and Triton X-100 (detergent) and then purified; the in vivo effect of the residual S/D has been reported to be minimal. In clinical transfusion practice, ABO-incompatible, HLA-matched, single-donor platelets may have to be resuspended in ABO-compatible plasma. The use of S/D-treated plasma for this purpose would remove the added risk of transfusion-transmitted diseases due to the use of another blood component. As there are no data on the use of S/D-treated plasma as a platelet-resuspending medium, the potential toxicity of the residual solvent and detergent on the in vitro function and integrity of platelets stored in S/D-treated plasma for 5 days was studied. A repeated-measures analysis of variance was used for statistical analysis. Results showed that, as compared to controls (non-S/D-treated plasma), platelets resuspended in S/D-treated plasma maintained their functional properties, including morphology score and osmotic recovery, for up to 5 days of storage (p > 0.05, NS). No significant changes were seen among S/D-treated plasma and control groups for platelet count, lactate dehydrogenase discharge, beta-thromboglobulin release, glucose utilization, or generation of lactate. Measurement of pO2 and pCO2 values showed some differences between S/D-treated plasma and control groups that were significant, but not clinically significant. The pH values for all four groups ranged from 7.1 to 7.4 on Day 5.(ABSTRACT TRUNCATED AT 250 WORDS)

Transfusion-transmitted babesiosis: a case report from a new endemic area.

The seventh documented case of babesiosis transmitted by transfusion is reported. Both the donor and the recipient are residents of Connecticut, where the presence of endemic babesiosis has only recently been established. As the range of Babesia microti, and its vector the Ixodes dammini tick, continues to expand, clinicians and blood bank directors should be aware that cases of transfusion-transmitted babesiosis may occur in newly endemic areas.

Survival of Borrelia burgdorferi in blood products.

The incidence of Lyme disease is rapidly increasing in the United States. To assess the potential of transmission of the disease through blood transfusion, we studied the survival of Borrelia burgdorferi in blood products under blood bank storage conditions. Two units of whole blood, separated into red cells (RBCs), fresh-frozen plasma (FFP), and platelet concentrates (PCs), were inoculated with B. burgdorferi (strain B31) in concentrations of approximately 3000 organisms per mL of RBCs and FFP and 200 organisms per mL of PCs. Products were then stored under blood banking conditions and sampled at several storage times. The viability of the spirochete in blood components was determined by darkfield microscopic examination of cultures in modified Kelly's medium. The organism was shown to survive in RBCs (4 degrees C) and FFP (below -18 degrees C) for 45 days and in PCs (20-24 degrees C) for 6 days. The results of this study do not exclude the possibility of transmission of Lyme disease through blood transfusion.

Iron supplementation in female blood donors deferred by copper sulfate screening.

Female blood donors with low hematocrit levels detected by copper sulfate screening were selected randomly to receive either 75 mg of iron per day, as ferrous gluconate, or a calcium phosphate placebo. Their ferritin, serum iron, total iron-binding capacity, zinc protoporphyrin, and hemoglobin values, as well as their suitability to donate blood, were determined initially (Visit 1) and at four follow-up visits (Visits 2-5). By the second visit, the serum ferritin and iron values of donors receiving iron supplementation differed significantly from those of donors receiving placebo. By the fifth visit, a less marked but significant increase in hemoglobin had occurred in the iron group, but not in the placebo group. At no time was there a significant difference between the groups' suitability to donate blood, with each group donating at almost half of their visits. The authors conclude that iron supplementation at this dose level in deferred female blood donors improves their iron status and hemoglobin levels, but does not significantly increase their suitability to donate blood as compared with the suitability of placebo-treated donors.