Few SP donors have iron depletion and it is not higher in frequent donors. Frequent SP donation does not adversely impact iron stores. Thus, monitoring donor iron status or iron supplementation is not necessary.

Background and Objectives LDL apheresis is used to treat patients with familial hypercholesterolaemia, and low-volume plasmapheresis for plasma donation may similarly lower cholesterol levels in some donors. This study was designed to assess the effect of plasmapheresis on total, LDL and HDL cholesterol levels in a plasma donor population.Materials and Methods This was a prospective, unblinded longitudinal cohort study in which a blood sample was obtained for analysis before each donation. Data from 663 donors were analysed using a multivariable repeated measures regression model with a general estimating equations approach with changes in cholesterol as the primary outcome measure.Results The model predicted a significant decrease in total and LDL cholesterol for both genders and all baseline cholesterol levels (P < 0·01). The greatest total cholesterol decreases (women, −46·8 mg/dL; men, −32·2 mg/dL) were associated with high baseline levels and 2–4 days between donations. Small but statistically significant increases (P ≤ 0·01) in HDL cholesterol were predicted for donors with low baseline levels.Conclusions These results suggest that, in donors with elevated baseline cholesterol levels, total and LDL cholesterol levels may decrease during routine voluntary plasmapheresis.

BACKGROUND Uniform and consistent reporting and comparison of donor adverse events (DAEs) and severity are well‐recognized challenges for donor hemovigilance (DHV). While the 2014 Standard for Surveillance of Complications Related to Blood Donation (SSCRBD), developed by hemovigilance experts from AABB, the International Society of Blood Transfusion, and International Hemovigilance Network, established the DAE definitions, no specific guidelines were provided to grade severity. A group of subject matter experts developed the Severity Grading Tool for Blood Donor Adverse Events (SGT) to enhance objective assignment of severity and conducted a study to validate the tool. STUDY DESIGN AND METHODS Between January 8, 2019, and February 28, 2019, participants graded severity of 32 cases (34 DAEs) using the SGT. Comments boxes allowed participants to provide rationale for selecting a severity grade for each case. Agreement with expert grading among study participants was evaluated using percentage agreement. Inter‐rater reliability was evaluated by Kendallʼs coefficient of concordance (W). The final SGT was revised based on validation study results and feedback received. RESULTS The overall agreement was almost perfect with W = 0.84 (confidence interval [CI], 0.78‐0.90). Of 34 DAEs, respondent agreement with expert grading of more than 90% was reached for 18 DAEs, 80% to 90% for six DAEs, 70% to 80% for six DAEs, and less than 70% for four DAEs. CONCLUSION The development and validation of a uniform SGT with objective criteria for assigning severity of DAEs used together with standard reaction definitions will provide opportunities for comparison between blood centers and systems to enhance the field of DHV.

Existing normative flow cytometry data have several limitations including small sample sizes, incompletely described study populations, variable flow cytometry methodology, and limited depth for defining lymphocyte subpopulations. To overcome these issues, we defined high-dimensional flow cytometry reference ranges for the healthy human immune system using Human Immunology Project Consortium methodologies after carefully screening 127 subjects deemed healthy through clinical and laboratory testing. We enrolled subjects in the following age cohorts: 18-29 years, 30-39, 40-49, and 50-66 and enrolled cohorts to ensure an even gender distribution and at least 30% non-Caucasians. From peripheral blood mononuclear cells, flow cytometry reference ranges were defined for >50 immune subsets including T-cell (activation, maturation, T follicular helper and regulatory T cell), B-cell, and innate cells. We also developed a web tool for visualization of the dataset and download of raw data. This dataset provides the immunology community with a resource to compare and extract data from rigorously characterized healthy subjects across age groups, gender and race.

We determined normative data for plasma cytokines established from a cohort of 126 carefully screened healthy adults aged 18 to 64 years. Participants were enrolled to ensure an even age and sex distribution and to include at least 30% non-Caucasians. Plasma cytokines for 18 analytes were tested by multiplex immunoassay. The data are presented by age cohort (18–29 years, 30–39, 40–49, and 50–66), as well as by sex and racial background. This dataset complements published normative ranges of cellular subsets generated by comprehensive polychromatic flow cytometry analysis of the healthy human immune system [1]. These data are available to researchers and have value as a reference range for research involving peripheral cytokines.

Background and ObjectivesDonor plasmapheresis involves the removal of a weight-adjusted volume of plasma and the return of cellular components to the donor. Although plasma volume generally returns to normal, some residual effect on vital signs may be possible. This analysis was performed to determine the possible effects of plasmapheresis on blood pressure.Materials and MethodsA 16-week study was conducted to evaluate the effects of plasma donations on cholesterol levels in healthy donors. From this study, the vital signs obtained prior to donation were analysed using statistical and dynamic analytical predictive models.ResultsPreliminary analyses revealed a change in systolic and diastolic blood pressure from the corresponding baseline values (Pearson Coefficient −0·44 and −0·47, respectively). Statistical models predicted a marked decrease in systolic and diastolic blood pressure following multiple donations in donors with baseline pressure in the Stage 2 hypertension range with less pronounced decreases predicted in Stage 1 donors. Little or no change in blood pressure was predicted in donors with baseline normal blood pressure or prehypertension. Dynamic models including time between donations supported these results and predicted a recovery period of about 14 days without donation in donors with Stage 2 baseline levels.ConclusionsResults suggest that systolic and diastolic blood pressure may be decreased following plasmapheresis used for plasma donations at intervals of <14 days in donors with high baseline blood pressure levels.

Background The COVID-19 pandemic highlighted plasma as a strategic resource with continually increasing demand. Demographic data for plasma donors are limited compared with blood donors. Increased information regarding pre-pandemic donor demographics may serve as a baseline for evaluation of post-pandemic practices. OBJECTIVES This study asked the question, “What were the demographics of source plasma donors in the US compared to the general population and how did these change over a five-year period preceding the pandemic?” STUDY DESIGN Donor demographic data were retrospectively analyzed for the years 2014, 2016 and 2018 from a network of US plasma centers. METHODS Routine demographic data obtained prior to source plasma collection from all plasma donors at Grifols US centers were retrospectively analyzed. Donor screening and eligibility requirements were standardized across all donor sites and met all donor eligibility requirements (Code of Federal Regulations: 21 CFR part 600). During each calendar year, only data from the first donation in that year were included with each cohort year. RESULTS This study included 1,303,049 unique donors. Donors were predominantly young adult males, although females increased from 37.4% to 41.6%. Caucasians constituted the highest proportion, followed by African American and Hispanic donors. Demographics were generally stable, but the 2018 cohort and the US population exhibited significantly different age, race/ethnicity, and sex profiles. Of 2014 donors, 9.0% returned in all three years studied (2014-2016-2018), with a higher return rate of 16.0% observed for donors returning in just two of the years (2014-2016). Multiyear donors were predominantly male and African American. CONCLUSION US plasma donor demographics over a five-year period (2014-2018) showed generally consistent characteristics but differed from the general US population. Multiyear donors were demographically distinct from single-year donors. These data serve as a snapshot of the US source plasma donor base prior to the COVID-19 pandemic.