BACKGROUND: Genetic determinants may underlie the susceptibility of red blood cells (RBCs) to hemolyze in vivo and during routine storage. This study characterized the reproducibility and dynamics of in vitro hemolysis variables from a subset of the 13,403 blood donors enrolled in the RBC-Omics study. STUDY DESIGN AND METHODS: RBC-Omics donorswith either low or high hemolysis results on 4 C-stored leukoreduced (LR)-RBC samples from enrollment donations stored for 39 to 42 days were recalled 2 to 12 months later to donate LR-RBCs. Samples of stored LR-RBCs from the unit and from transfer bags were evaluated for spontaneous and stress-induced hemolysis at selected storage time points. Intradonor reproducibility of hemolysis variables was evaluated in transfer bags over two donations. Hemolysis data at serial storage time points were generated on LR-RBCs from parent bags and analyzed by site, sex, race/ ethnicity, and donation frequency. RESULTS:A total of 664 donors were successfully recalled. Analysis of intradonor reproducibility revealed that osmotic and oxidative hemolysis demonstrated good and moderate reproducibility (Pearson's r = 0.85 and r = 0.53, respectively), while spontaneous hemolysis reproducibility was poor (r = 0.40). Longitudinal hemolysis in parent bags showed large increases over time in spontaneous (508.6%) and oxidative hemolysis (399.8%) and smaller increases in osmotic (9.4%) and mechanical fragility (3.4%; all p < 0.0001). CONCLUSION: Spontaneous hemolysis is poorlyreproducible in donors over time and may depend on site processing methods, while oxidative and osmotic hemolysis were reproducible in donors and hence could reflect consistent heritable phenotypes attributable to genetic traits. Spontaneous and oxidative hemolysis increased over time of storage, whereas osmotic and mechanical hemolysis remained relatively stable.

BACKGROUND The historical approach of offering dietary advice to donors with low hemoglobin (Hb) is ineffective for preventing iron deficiency in frequent donors. Alternative approaches to maintaining donor iron status were explored. STUDY DESIGN AND METHODS Frequent blood donors were randomly assigned into five arms for 2 years of follow-up. Three double-blinded arms provided 60 once-daily pills after each donation (38, 19, or 0 mg of iron). Two single-blinded arms provided iron status (ferritin) or no information letters after each donation. Ferritin, soluble transferrin receptor, and complete blood count were measured at each donation. RESULTS There were 692 subjects enrolled and 393 completed the study. Subjects in pill groups deenrolled more than those in letter groups (39% vs. 7%). Adverse events occurred equally in subjects receiving iron or placebo pills. Of those completing the study, the prevalence of ferritin of less than 12 or less than 26 ng/mL declined by more than 50% and was statistically indistinguishable in the three intervention groups (19 or 38 mg of iron; iron status letter). Longitudinal analyses of all subjects showed improved iron status in iron pill groups and worsening iron status in control groups (placebo; no information letter). The iron pill groups experienced a net increase of approximately 0.6 g/dL Hb compared to control groups. The iron status letter group had little change in Hb. CONCLUSION Providing 19 or 38 mg of daily iron or iron status information were effective and mostly equivalent interventions for mitigating iron deficiency in regular donors when compared at the end of the 2-year longitudinal phase of the study. Donors without intervention had worsened iron deficiency with continued donation.

Introduction Blood transfusion is one of the most common medical procedures during hospitalization in the United States. To understand the benefits of transfusion while mitigating potential risks, a multicenter database containing detailed information on transfusion incidence and recipient outcomes would facilitate research. Methods The Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program has developed a comprehensive transfusion recipient database utilizing data from hospital electronic health records at 12 participating hospitals in four geographic regions. Transfused inpatient and outpatient data from January 1, 2013 until December 31, 2014 included patient age, sex, ethnicity, primary diagnosis, type of blood product provided, issue location, pre- and post-transfusion hemoglobin, and hospital outcomes. Transfusion incidence per encounter was calculated by blood product and various patient characteristics. Results During the two-year study period, 80,362 (12.5%) inpatient encounters involved transfusion. Among inpatients, the most commonly transfused blood products were red cells (10.9% of encounters), followed by platelets (3.2%), and plasma (2.9%). Among transfused patients, the median number of red-cell units was one, pre-transfusion hemoglobin was 7.6 g/dL, and hemoglobin increment/unit was 1.4 g/dL. Encounter mortality increased with patient age, number of units transfused, and the use of platelet or plasma products. The most common reported transfusion reaction was febrile non-hemolytic. Conclusion The REDS-III recipient database contains comprehensive data regarding transfusion use and patient outcomes. This report describes an evaluation of the first two years of a planned four-year linked blood donor-component-recipient database which represents a critical new resource for transfusion medicine researchers.

Background: Using the REDS-III recipient and donor databases, we performed a retrospective analysis of platelet use in 12 U.S. hospitals that were participants in REDS-III.Study Design and Methods: Data were electronically extracted from participating transfusion service and blood center computer systems, and from medical records of the 12 REDS-III hospitals. All platelet transfusions from 2013-2016 given to patients 18 and older were included in the analysis.Results: There were 28,843 inpatients and 2,987 outpatients who were transfused with 163,719 platelet products (103,371 apheresis, 60,348 whole blood derived). 93.5% of platelet products were leukocyte reduced and 72.5% were irradiated. 46% were transfused to patients with an ICD 9/10 diagnosis of leukemia, MDS or lymphoma. The general ward and the ICU were the most common issue locations. Only 54% of platelet transfusions were ABO identical; and 60.6% of platelet transfusions given to Rh negative patients were Rh positive. The most common pre-transfusion platelet count range for inpatients was 20,000-50,000/µL, for outpatients it was 10,000-20,000/µL. Among ICU patients, 35% of platelet transfusion episodes had a platelet count of greater than 50,000/µL, this was only 8% for general ward and 2% for outpatients. The median post-transfusion increment ranged from 12,000-20,000/µL for inpatients, and from 17,000-27,000/µL for outpatients. Conclusions:These data from one of the largest reviews of platelet transfusion practice to date provide guidance for where to focus future clinical research studies [i.e. platelet use for moderate thrombocytopenia (20,000 to 100,000/μL), anticoagulation and platelet use in oncology patients, platelet use prior to a procedure] and platelet Blood Management programs.

Background In the US, any man who discloses having had sex with another man (MSM) even once since 1977 is currently deferred from donating blood. A study was conducted to assess noncompliance with the policy at four geographically dispersed blood centers. Methods Male donors 18+ years of age with email addresses were randomly selected and invited to complete a confidential online survey between Aug – Oct 2013. No additional recruitment emails were sent. Survey content included: demographics, sexual history, donation history, compliance with the policy, and opinions about current and modified policies. Results Response rate was 11.5% overall but varied by center (6.3 to 21.7%). Of 3183 completed surveys, 2.6% of respondents (95% Confidence Interval 2.1 – 3.2%) reported donation after male-male sex. Noncompliance was not statistically different among the centers [p=0.1], but was related to age with 5.7%, 4.6%, 2.5%, and 1.0% of donors 18-24, 25-34, 35-54, and 50+ years of age, respectively, reporting noncompliance [p<0.001]. Of all respondents, 6.8% reported ≥6 female sex partners and 0.3% reported ≥6 male sex partners in the last five years. Opinions about the current MSM policy were mixed with noncomplying donors more supportive of change than complying donors. About half of noncompliers indicated they would adhere to a 1-year deferral policy. Conclusion Noncompliance with the MSM policy is evident and may be increasing compared to earlier data. It is expected that any change from the current policy will require close monitoring to determine whether it affects residual risk of HIV in the US blood supply.