The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial.
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ABSTRACT: Background
The demand for plasma products is growing, necessitating an increase in plasma collection by plasmapheresis. While the 20th edition of the European Guidelines permits plasma donors in Europe to donate with 96-h donation intervals, the potential short- and long-term consequences of high-frequency plasma donations on donor health remain unknown. This study aims to measure the effect of plasma donation frequency on plasma protein composition, including total serum protein (TSP) and immunoglobulin G (IgG), in Norwegian male blood donors.Methods
This randomized controlled trial (RCT) included 120 male blood donors who were randomized into two intervention groups and one control group: high-frequency plasma donors (HFPDs) who donated 650 mL of plasma 3 times every 2 weeks, whereas regular-frequency plasma donors (RFPDs) who donated 650 mL of plasma 1 time every 2 weeks. The control group consisted of whole blood donors. The primary outcomes are the concentrations of TSP and IgG.Discussion
The findings from this study may have implications for recommendations related to donor health and plasma donation frequencies and may contribute to supporting the strategic independence of plasma products in Norway and Europe without compromising donor health.Trial registration
ClinicalTrials.gov: NCT05179200 . Registered December 20th, 2021.
SUBMITTER: Haugen M
PROVIDER: S-EPMC10926559 | biostudies-literature | 2024 Mar
REPOSITORIES: biostudies-literature
Publications
The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial.
Haugen Morten M Magnussen Karin K Aarsland Tonje Eiane TE Nissen-Meyer Lise Sofie Haug LSH Strand Tor A TA
Trials 20240311 1
<h4>Background</h4>The demand for plasma products is growing, necessitating an increase in plasma collection by plasmapheresis. While the 20th edition of the European Guidelines permits plasma donors in Europe to donate with 96-h donation intervals, the potential short- and long-term consequences of high-frequency plasma donations on donor health remain unknown. This study aims to measure the effect of plasma donation frequency on plasma protein composition, including total serum protein (TSP) a ...[more]
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Project description:IntroductionPlasmapheresis donation is considered safe and well tolerated, although long-term effects need to be clarified. The volumes of anticoagulant (ACD-A) used are variable and depend primarily on hematocrit (HCT), total blood processed, amount of plasma collected, and donor characteristics. To elucidate the effect of the plasma unit weight setting on plasmapheresis efficiency and ACD-A distribution, we enrolled male donors undergoing a controlled apheresis process donating 700 g and 720 g in two different sessions. In parallel, we investigated a possible effect of sex, recruiting women donating 700 g of plasma.MethodsThe study was conducted on men donating 720 g and (12 months later) 700 g of plasma, and on women donating 700 g of plasma. The main outcomes were pre-/post-donation delta (Δ) citrate concentration in donor plasma and ACD-A reinfused to the donor. Information concerning the annual check-up and the procedure was also collected. Intergroup comparisons (men donating 720 g vs. men donating 700 g and men vs. women both donating 700 g) and intragroup associations with donor and procedural characteristics were reported.ResultsWith the procedure set at 720 g, the machine processed around 44 mL more whole blood to collect 20 g more plasma, and 720 g donors received around 12 mL more anticoagulant than 700 g donors. Accordingly, Δ citrate concentration was 1.5 times higher (12 μm), with a greater variability observed for 720 g donations. Citrate concentration in the plasma unit was lower in the 720 g group, although not significantly. Comparing outcomes between women and men donating 700 g, we observed higher (and highly variable) Δ citrate and reinfused ACD-A in women, accompanied by lower anticoagulant levels in the unit. Increased Δ citrate is inversely associated with HCT and age in men and with HCT and triglycerides in women. Reinfused ACD-A correlates with HCT in women but not in men.ConclusionUnit weight setting and sex influence an ACD-A shift from the estimated values toward an increased reinfusion to donor. In parallel, we observed an impact of age and sex on post-donation citrate metabolism. Altogether, these elements should be taken into account for the development of tailored approaches aimed at maintaining similar safety profiles for all donors using different plasmapheresis settings.
| S-EPMC10712964 | biostudies-literature
Project description:Background and objectivesHomophily represents the extent to which people feel others are like them and encourages the uptake of activities they feel people like them do. Currently, there are no data on blood donor homophily with respect to (i) people's representation of the average prototypical UK blood donor and (ii) the degree of homophily with this prototype for current donors, non-donors, groups blood services wish to encourage (ethnic minorities), those who are now eligible following policy changes (e.g., men-who-have-sex-with-men: MSM) and recipients. We aim to fill these gaps in knowledge.Materials and methodsWe surveyed the UK general population MSM, long-term blood recipients, current donors, non-donors and ethnic minorities (n = 785) to assess perceptions of the prototypical donor in terms of ethnicity, age, gender, social class, educational level and political ideology. Homophily was indexed with respect to age, gender and ethnicity.ResultsThe prototypical UK blood donor is perceived as White, middle-aged, middle-class, college-level educated and left-wing. Current donors and MSM are more homophilous with this prototype, whereas recipients and ethnic minorities have the lowest homophily. Higher levels of homophily are associated with an increased likelihood of committing to donate.ConclusionThe prototype of the UK donor defined this as a White activity. This, in part, may explain why ethnic minorities are less likely to be donors. As well as traditional recruitment strategies, blood services need to consider broader structural changes such as the ethnic diversity of staff and co-designing donor spaces with local communities.
| S-EPMC11634441 | biostudies-literature
Project description:BackgroundThe loss of iron stores and resulting iron deficiency is well documented in whole blood or red blood cell donors. We hypothesized that relative iron deficiency also occurs as a result of more frequent platelet- and plasma-pheresis (apheresis) donation.Materials and methodsTo test this hypothesis, we proposed a pilot cross-sectional study to analyze erythropoiesis- and iron-related parameters in white male apheresis donors: (1) relative to controls, (2) in correlation with apheresis donation frequency, and (3) in correlation with pre-donation platelet count.ResultsFifty eligible apheresis donors and eight controls were enrolled in the study. Apheresis donors were found to have a lower serum ferritin and serum hepcidin and exhibited evidence of iron restricted erythropoiesis relative to controls. Furthermore, among donors, lower MCV, CHr , hepcidin concentration, and serum ferritin were observed in more frequent apheresis donors. Correlations between donation frequency and hepcidin and ferritin were noted in apheresis donors.ConclusionsThis pilot study demonstrates that apheresis donors are relatively iron deficient compared to controls and supports the premise that frequent apheresis donation correlates with relatively iron restricted erythropoiesis. An analysis of iron- and erythropoiesis-related parameters in a broader population of frequent apheresis donors (i.e., female and non-white donors) may demonstrate larger deficits and an even greater potential benefit of iron replacement. J. Clin. Apheresis 31:551-558, 2016. © 2015 Wiley Periodicals, Inc.
| S-EPMC7733305 | biostudies-literature
Project description:BackgroundSince early 2020, convalescent plasma has been widely used for treating coronavirus disease 2019 (COVID-19). There is limited information regarding donor tolerability of convalescent plasma donation. In this study, we evaluated the short-term donor tolerability of convalescent plasma donation.MethodsA prospective study of 309 convalescent plasma donation related adverse events were conducted at Wuhan Blood Center of China, from February 12 to April 1, 2020. Additionally, up to 28-day post-donation follow-ups were performed on the donors.ResultsSixteen (5.2%) adverse events were reported in 309 donations. All of these were mild vasovagal without loss of consciousness. The frequency of adverse reactions was higher in donors with a per donation volume of >8 mL/kg body weight or ≥ 600 mL, <100 mm Hg in pre-donation systolic blood pressure, or less than 28 days from the onset of COVID-19 symptoms. There was no correlation to donation history, weight, sex, ABO blood type, pre-donation diastolic blood pressure, pulse, or hemoglobin.ConclusionThe donation of convalescent plasma is generally safe. Mitigation of risk factors associated with adverse events can further enhance donor tolerability of convalescent plasma donation.
| S-EPMC8013347 | biostudies-literature
Project description:ImportanceBlood donation is critical for health care systems, but donor retention remains challenging. Understanding donors' preferences can inform incentive design and improve retention rates.ObjectiveTo identify donor preferences for incentive attributes and their relative importance in promoting blood donation among Chinese donors in Shandong.Design, setting, and participantsThis survey study fielded a discrete choice experiment (DCE) with a dual response design among blood donors, analyzing the responses under forced and unforced choice settings. The study took place from January 1 to April 30, 2022, in 3 cities (Yantai, Jinan, and Heze) representing diverse socioeconomic strata in Shandong, China. Eligible participants were blood donors aged 18 to 60 years who had donated within the preceding 12 months. Participants were recruited using convenience sampling. Data were analyzed from May to June 2022.ExposureRespondents were presented with different blood donation incentive profiles, varying in health examination, blood recipient, honor recognition, travel time, and gift value.Main outcome and measureRespondent preferences for nonmonetary incentive attributes, attribute relative importance, willingness-to-discard values for attribute improvement, and estimated uptake of new incentive profiles.ResultsA total of 650 donors were invited, of which 477 were included for analysis. The respondents were predominately male (308 respondents [64.6%]), aged 18 to 34 years (291 respondents [61.0%]), and had undergraduate degrees or higher (286 respondents [59.9%]). Among the 477 valid respondents, the mean (SD) age was 31.9 (11.2) years. Respondents preferred comprehensive health examination, family members as recipients, central government recognition, 30-minute travel time, and a gift valued at 60 Renminbi (RMB). No significant differences were found between the model results of forced and unforced choice setting. Blood recipient was the most important attribute, followed by health examination and gifts, and then honor and travel time. Respondents were willing to discard RMB 32 (95% CI, 18-46) for an improved health examination and RMB 69 (95% CI, 47-92) for changing the recipient from themselves to family members. Scenario analysis estimated 80.3% (SE, 0.024) of donors would endorse the new incentive profile if the recipient was changed from themselves to family members.Conclusions and relevanceIn this survey study, blood recipient, health examination, and gift value were perceived more important as nonmonetary incentives than travel time and honor recognition. Tailoring incentives according to these preferences may improve donor retention. Further research could help refine and optimize incentive schemes for blood donation promotion.
| S-EPMC10267764 | biostudies-literature
Project description:BackgroundLimits on the frequency of whole blood donation exist primarily to safeguard donor health. However, there is substantial variation across blood services in the maximum frequency of donations allowed. We compared standard practice in the UK with shorter inter-donation intervals used in other countries.MethodsIn this parallel group, pragmatic, randomised trial, we recruited whole blood donors aged 18 years or older from 25 centres across England, UK. By use of a computer-based algorithm, men were randomly assigned (1:1:1) to 12-week (standard) versus 10-week versus 8-week inter-donation intervals, and women were randomly assigned (1:1:1) to 16-week (standard) versus 14-week versus 12-week intervals. Participants were not masked to their allocated intervention group. The primary outcome was the number of donations over 2 years. Secondary outcomes related to safety were quality of life, symptoms potentially related to donation, physical activity, cognitive function, haemoglobin and ferritin concentrations, and deferrals because of low haemoglobin. This trial is registered with ISRCTN, number ISRCTN24760606, and is ongoing but no longer recruiting participants.Findings45 263 whole blood donors (22 466 men, 22 797 women) were recruited between June 11, 2012, and June 15, 2014. Data were analysed for 45 042 (99·5%) participants. Men were randomly assigned to the 12-week (n=7452) versus 10-week (n=7449) versus 8-week (n=7456) groups; and women to the 16-week (n=7550) versus 14-week (n=7567) versus 12-week (n=7568) groups. In men, compared with the 12-week group, the mean amount of blood collected per donor over 2 years increased by 1·69 units (95% CI 1·59-1·80; approximately 795 mL) in the 8-week group and by 0·79 units (0·69-0·88; approximately 370 mL) in the 10-week group (p<0·0001 for both). In women, compared with the 16-week group, it increased by 0·84 units (95% CI 0·76-0·91; approximately 395 mL) in the 12-week group and by 0·46 units (0·39-0·53; approximately 215 mL) in the 14-week group (p<0·0001 for both). No significant differences were observed in quality of life, physical activity, or cognitive function across randomised groups. However, more frequent donation resulted in more donation-related symptoms (eg, tiredness, breathlessness, feeling faint, dizziness, and restless legs, especially among men [for all listed symptoms]), lower mean haemoglobin and ferritin concentrations, and more deferrals for low haemoglobin (p<0·0001 for each) than those observed in the standard frequency groups.InterpretationOver 2 years, more frequent donation than is standard practice in the UK collected substantially more blood without having a major effect on donors' quality of life, physical activity, or cognitive function, but resulted in more donation-related symptoms, deferrals, and iron deficiency.FundingNHS Blood and Transplant, National Institute for Health Research, UK Medical Research Council, and British Heart Foundation.
| S-EPMC5714430 | biostudies-literature
Project description:BackgroundFrequent whole blood donors have an increased risk of developing iron deficiency. Iron deficiency can have detrimental health effects when left untreated. Donation intervals are commonly too short to replenish iron stores and extending these reduces donor availability. Oral iron supplementation is known to shorten iron store recovery time but may also induce gastrointestinal complaints. We aim to optimise the effectiveness of iron supplements while minimising the risks of side effects. Therefore, we will evaluate the impact of different iron supplementation protocols in terms of dosage and frequency on ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return compared with placebo supplementation.MethodsTwelve hundred whole blood donors with ferritin levels ≤30 µg/L are included into a double-blind, randomised controlled trial. Participants are randomly allocated to one of six arms, administering capsules containing 0 mg, 30 mg or 60 mg of iron, either on alternate days or daily for 56 days. At baseline and 56, 122 and 182 days of follow-up, ferritin and haemoglobin levels are measured, and compliance, donor return, dietary iron intake, gastrointestinal, iron deficiency-related symptoms and general health are assessed by questionnaire.Ethics and disseminationThis study will provide a comprehensive overview of the effects of different frequencies and dosages of administration of iron supplements on iron status and health effects, thereby considering individual differences in treatment adherence and lifestyle. The outcome will provide scientific evidence to guide the debate if and how oral iron supplements may support the recovery of whole blood donors with low ferritin levels.Trial registration numberNL8590; The Dutch trial registry.
| S-EPMC8915278 | biostudies-literature
Project description:BackgroundAs a group of more than 3.67 million people, the bone health of Chinese plasmapheresis donors, which the main population is also a risk group of osteoporosis (OP), has raised concerns. Therefore, this article investigates the relationship between bone mineral density (BMD), bone metabolism indicators, and plasmapheresis donation behavior among some high-risk plasmapheresis donors for OP in China, and further explores the mediating factors through reasonable statistical methods.MethodsRecruiting long-term and highly active plasmapheresis donors and new donors to measure the total calcium, albumin (ALB), 25-hydroxy vitamin D (25OHD), parathyroid hormone (PTH), type I procollagen amino-terminal peptide (P1NP), and type I collagen carboxy-terminal peptide (β-CTX) and serum ferritin (SF). Then, multiple linear regression was used to adjust confounding factors. Using restrictive cubic splines to explore the nonlinear relationship. Using the Bootstrap method, investigate whether SF has a mediating effect between plasmapheresis donation behavior and bone metabolism biomakers. Finally, analyze the differences in BMD between the two.ResultsCompared to new donors, repeat donors have a lower 25OHD, β-CTX and SF levels, while P1NP and PTH levels are high, with statistical differences. The Bootstrap analysis results show that SF level is a partial mediating factor between plasmapheresis donation behavior and bone metabolism biomakers, with a mediating effect ratio of 21.8%. There was no significant difference in the BMD between the two.ConclusionLong-term and frequently plasmapheresis donation does not affect the bone mass of even elderly donors at high risk for osteoporosis under the existing collection standards and anticoagulant use in China. However, as a self-regulation way, it does increase the osteogenic activity of the body.
| S-EPMC11663400 | biostudies-literature
Project description:BackgroundBecause knowledge of blood donor motivation is crucial in guiding recruitment and retention efforts, the present study aimed at developing and validating a new scale as a multidimensional measure of blood donation motivation from the perspective of the self- determination theory.MethodsThis study was conducted in three phases from September 2022 to May 2023. The first phase involved developing a draft scale based on a literature review. In the second phase, face and content validity were performed. The third phase used a cross-sectional design to assess the construct validity and internal consistency of the initial scale following administration to blood donors with a history of at least one previous whole blood donation who visited the largest blood transfusion center in Iran. Of the 420 subjects who were recruited using a mixed sampling method, 343 who fully completed the initial version of the scale were subjected to an construct validity assessment using exploratory factor analysis with Equamax rotation and internal consistency using McDonald's omega coefficient.Main resultsThe initial version of the scale consisted of 30 survey items with both a content validity ratio and a content validity index of 0.99. Exploratory factor analysis identified 24 items; grouped in six regulation factors (non-regulation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation). The factors demonstrated adequate internal consistency with ω values ranging from 0.60 to 0.79.ConclusionThe present study provides psychometric support for the newly developed questionnaire to evaluate donation motivation among blood donors in Iran or in other countries with similar language, and religious and cultural values.
| S-EPMC11726103 | biostudies-literature
Project description:BackgroundThe INTERVAL trial showed that, over a 2-year period, inter-donation intervals for whole blood donation can be safely reduced to meet blood shortages. We extended the INTERVAL trial for a further 2 years to evaluate the longer-term risks and benefits of varying inter-donation intervals, and to compare routine versus more intensive reminders to help donors keep appointments.MethodsThe INTERVAL trial was a parallel group, pragmatic, randomised trial that recruited blood donors aged 18 years or older from 25 static donor centres of NHS Blood and Transplant across England, UK. Here we report on the prespecified analyses after 4 years of follow-up. Participants were whole blood donors who agreed to continue trial participation on their originally allocated inter-donation intervals (men: 12, 10, and 8 weeks; women: 16, 14, and 12 weeks). They were further block-randomised (1:1) to routine versus more intensive reminders using computer-generated random sequences. The prespecified primary outcome was units of blood collected per year analysed in the intention-to-treat population. Secondary outcomes related to safety were quality of life, self-reported symptoms potentially related to donation, haemoglobin and ferritin concentrations, and deferrals because of low haemoglobin and other factors. This trial is registered with ISRCTN, number ISRCTN24760606, and has completed.FindingsBetween Oct 19, 2014, and May 3, 2016, 20 757 of the 38 035 invited blood donors (10 843 [58%] men, 9914 [51%] women) participated in the extension study. 10 378 (50%) were randomly assigned to routine reminders and 10 379 (50%) were randomly assigned to more intensive reminders. Median follow-up was 1·1 years (IQR 0·7-1·3). Compared with routine reminders, more intensive reminders increased blood collection by a mean of 0·11 units per year (95% CI 0·04-0·17; p=0·0003) in men and 0·06 units per year (0·01-0·11; p=0·0094) in women. During the extension study, each week shorter inter-donation interval increased blood collection by a mean of 0·23 units per year (0·21-0·25) in men and 0·14 units per year (0·12-0·15) in women (both p<0·0001). More frequent donation resulted in more deferrals for low haemoglobin (odds ratio per week shorter inter-donation interval 1·19 [95% CI 1·15-1·22] in men and 1·10 [1·06-1·14] in women), and lower mean haemoglobin (difference per week shorter inter-donation interval -0·84 g/L [95% CI -0·99 to -0·70] in men and -0·45 g/L [-0·59 to -0·31] in women) and ferritin concentrations (percentage difference per week shorter inter-donation interval -6·5% [95% CI -7·6 to -5·5] in men and -5·3% [-6·5 to -4·2] in women; all p<0·0001). No differences were observed in quality of life, serious adverse events, or self-reported symptoms (p>0.0001 for tests of linear trend by inter-donation intervals) other than a higher reported frequency of doctor-diagnosed low iron concentrations and prescription of iron supplements in men (p<0·0001).InterpretationDuring a period of up to 4 years, shorter inter-donation intervals and more intensive reminders resulted in more blood being collected without a detectable effect on donors' mental and physical wellbeing. However, donors had decreased haemoglobin concentrations and more self-reported symptoms compared with the initial 2 years of the trial. Our findings suggest that blood collection services could safely use shorter donation intervals and more intensive reminders to meet shortages, for donors who maintain adequate haemoglobin concentrations and iron stores.FundingNHS Blood and Transplant, UK National Institute for Health Research, UK Medical Research Council, and British Heart Foundation.
| S-EPMC7029279 | biostudies-literature