Abstract

OBJECTIVE Most of the previous studies of drone transport of blood samples examined normal blood samples transported under tranquil air conditions. We studied the effects of 1- and 2-hour drone flights using random vibration and turbulence simulation (10-30 g-force) on blood samples from 16 healthy volunteers and 74 patients with varying diseased. METHODS Thirty-two of the most common analytes were tested. For biochemical analytes, we used plasma collected in lithium heparin tubes with and without separator gel. Gel samples were analyzed for the effect of separation by centrifugation before or after turbulence. Turbulence was simulated in an LDS V8900 high-force shaker using random vibration (range, 5-200 Hz), with samples randomly allocated to 1- or 2-hour flights with 25 or 50 episodes of turbulence from 10 to 30 G. RESULTS For all hematologic and most biochemical analytes, test results before and after turbulence exposure were similar (bias < 12%, intercepts < 10%). However, aspartate aminotransferase, folate, lactate dehydrogenase and lipid index increased significantly in samples separated by gel and centrifugation prior to vibration and turbulence test. These changes increased form 10 G to 30 G, but were not observed when the samples were separated after vibration and turbulence. CONCLUSIONS Whole blood showed little vulnerability to turbulence, whereas plasma samples separated from blood cells by gel may be significantly influenced by turbulence when separated by spinning before the exposure. Centrifugation of plasma samples collected in tubes with separator gel should be avoided before drone flights that could be subject to turbulence.

Abstract

BACKGROUND Source plasma is essential to support the growing demand for plasma-derived medicinal products. Supply is short, with donor availability further limited by the COVID-19 pandemic. This study examined whether a novel, personalized, technology-based nomogram was non-inferior with regard to significant hypotensive adverse events (AEs) in healthy donors. STUDY DESIGN AND METHODS IMPACT (IMproving PlasmA CollecTion) was a prospective, multi-center, double-blinded, randomized, controlled trial carried out between January 6 and March 26, 2020 in three U.S. plasma collection centers. Donors were randomized to the current simplified 1992 nomogram (control) or a novel Percent Plasma Nomogram (PPN) with personalized target volume calculation (experimental). Primary endpoint was the rate of significant hypotensive AEs. Non-inferiority (NI) was tested with a margin of 0.15%. Collected plasma volume was a secondary endpoint. RESULTS 3,443 donors (Mean [SD] BMI: 32 (7.74) kg/m(2) ; 65% male) underwent 23,137 donations (Median [range]: 6 [1-22] per subject). Ten significant hypotensive AEs were observed (6 control; 4 experimental), with model-based AE incidence rate estimates (95% CI) of 0.051% (0.020%, 0.114%) and 0.035% (0.010%, 0.094%), respectively (p=0.58). NI was met at an upper limit of 0.043% versus the predefined margin of 0.15%. There was no statistical difference between total AE (all AE types: p=0.32). Mean plasma volume collected was 777.8 mL (control) versus 841.7 mL (experimental); an increase of 63.9 mL per donation (8.2%; p<0.0001). CONCLUSION This trial showed that a novel personalized nomogram approach in healthy donors allowed approximately 8% more plasma per donation to be collected without impairing donor safety. This article is protected by copyright. All rights reserved.

Abstract

BACKGROUND Plateletpheresis is generally safe but may have adverse reactions. Adverse reactions can negatively influence donor recruitment and retention. Valsalva is a proven method of attenuating pain caused by venipuncture. AIMS The aim was to evaluate the efficacy of the Valsalva maneuver on the attenuation of needle pain and donor anxiety. SETTINGS AND DESIGN This prospective randomized controlled trial was conducted between November 2015 and April 2016 at the Department of Transfusion Medicine. SUBJECTS AND METHODS One-hundred and sixty consecutive donors were grouped into control group (C) and Valsalva group (V) each of sample size 80. The Valsalva group performed a Valsalva maneuver and control did nothing before the venipuncture. Anxiety and pain were scored using a 10 cm visual analog scale (VAS). Severity was graded as VAS = 0 defines no pain and anxiety, VAS = 1-3 as mild pain and anxiety, VAS = 4-6 as moderate pain and anxiety, VAS = 7-9 as severe pain and anxiety, whereas VAS = 10 denotes extreme pain and anxiety. STATISTICAL ANALYSIS Statistical Package for Social Sciences, version 23 was used for analysis. Independent samples t-test/Mann-Whitney U-test was used to compare between treatment and control group, whereas the Wilcoxon signed-rank test was used to test the difference between pre- and postobservations. RESULTS In the Valsalva group, post-Valsalva anxiety levels were significantly reduced to (1 [0-2]) from their pre-Valsalva values of (2 [0-3]); (P < 0.001). Pain was significantly lower (2[1-2]) in Valsalva group compared to control (4[2-5]); (P < 0.001). CONCLUSIONS Valsalva reduced both severity of venipuncture pain and anxiety. Valsalva can be performed by donors as it is an easy, painless, and nonpharmacological method of pain and anxiety attenuation.

Abstract

Whole blood donation rapidly removes approximately 10% of a donor's blood volume and stimulates substantial changes in iron metabolism and erythropoiesis. We sought to identify donors who benefit from iron supplementation, describe the nature of the benefit, and define the time course for recovery from donation. Blood samples were collected over 24 weeks following whole blood donation from 193 participants, with 96 participants randomized to 37.5 mg daily oral iron. Changes in total body, RBC, and storage iron, hepcidin, erythropoietin, and reticulocyte count were modeled using semiparametric curves in a mixed model and compared among six groups defined by baseline ferritin (<12; 12-50; ≥50 ng/mL) and iron supplementation. The effect of oral iron on storage and RBC iron recovery was minimal in donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12 ng/mL had a "ripple" increase in reticulocytes ~100 days after donation indicating physiological responses occur months following donation. Iron supplements markedly enhance recovery from whole blood donation in donors with ferritin <50 ng/mL. However, full recovery from donation requires over 100 days when taking iron. The findings also highlight the value of the study of blood donors for understanding human hemoglobin and iron metabolism and their usefulness for future studies as additional biomarkers are discovered. This article is protected by copyright. All rights reserved.

Abstract

BACKGROUND Every day, blood banks worldwide face the challenge of ensuring an adequate blood supply. Iron deficiency is by far the most common cause of deferral of blood donors. The aim of the present study was to determine the effect of iron supplementation after repeated blood donation on iron status and physiological performance. MATERIALS AND METHODS Forty-four moderately trained and iron-replete subjects were randomly divided into a whole blood donation (n=36) and a placebo donation (n=8) group. One third of the donation group received no iron supplementation, whereas one third received 20 mg iron and one third received 80 mg iron daily for 28 days. The subjects were intended to make three donations 3 months apart, and recovery of endurance capacity, assessed by an incremental maximal cycling test, and haematological parameters was monitored up to 28 days after each donation. RESULTS Negative effects of repeated blood donation were found for markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers. Iron supplementation did not affect iron storage but did limit, at the highest dose of 80 mg, the effect of blood donations on functional iron and/or iron metabolism regulation, and at both 20 and 80 mg the negative effects on maximal power output and peak oxygen consumption. DISCUSSION Iron supplementation limited the deleterious effects of repeated blood donation on endurance sport performance but not on decline in iron status in iron-replete young men. These results underline the importance of iron supplementation to minimise the deleterious effects of blood donation on physiological functions, and the necessity to optimise the supplementation strategy to preserve iron status.

Abstract

We investigated whether intravenous iron supplementation improves fatigue and general health in non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L). Of 1,487 potentially eligible participants, 203 were randomly assigned to a single intravenous dose of 800 mg iron-carboxymaltose and 202 to placebo; 393 participants completed the trial. At 6 to 8 weeks after intervention, self-rated mean fatigue scores (numeric rating scale from 1-10, primary outcome) were 3.9 ± 1.8 in the iron supplementation group and 4.0 ± 2.2 in the placebo group, showing no group difference (p = 0.819). Pre-specified subgroup analyses of gender, ferritin < 25 µg/L and fatigue ≥ 4 points, as well as exploratory analyses of lower ferritin cut-offs did not reveal any between-group differences. In terms of secondary outcomes, the mean differences were 114.2 µg/L for ferritin (95% CI 103.1-125.3) and 5.7 g/L for hemoglobin (95% CI 4.3-7.2) with significantly higher values in the iron supplementation group. No group differences were observed for different measures of general well-being and other clinical and safety outcomes. Intravenous iron supplementation compared with placebo resulted in increase of ferritin and hemoglobin levels in repeat blood donors with low iron stores, yet had no effect on fatigue and general well-being.

Abstract

There is a growing interest in precision medicine where individual heterogeneity is incorporated into decision-making and treatments are tailored to individuals to provide better healthcare. One important aspect of precision medicine is the estimation of the optimal individualized treatment rule (ITR) that optimizes the expected outcome. Most methods developed for this purpose are restricted to the setting with two treatments, while clinical studies with more than two treatments are common in practice. In this work, we summarize methods to estimate the optimal ITR in the multi-arm setting and compare their performance in large-scale clinical trials via simulation studies. We then illustrate their utilities with a case study using the data from the INTERVAL trial, which randomly assigned over 20,000 male blood donors from England to one of the three inter-donation intervals (12-week, 10-week, and eight-week) over two years. We estimate the optimal individualized donation strategies under three different objectives. Our findings are fairly consistent across five different approaches that are applied: when we target the maximization of the total units of blood collected, almost all donors are assigned to the eight-week inter-donation interval, whereas if we aim at minimizing the low hemoglobin deferral rates, almost all donors are assigned to donate every 12 weeks. However, when the goal is to maximize the utility score that "discounts" the total units of blood collected by the incidences of low hemoglobin deferrals, we observe some heterogeneity in the optimal inter-donation interval across donors and the optimal donor assignment strategy is highly dependent on the trade-off parameter in the utility function.

Abstract

BACKGROUND Blood collection centers are charged with creating donor educational materials (DnEM) that are easily understood across all prospective donor populations, while addressing mandates and recommendations from regulatory agencies and professional standard setting organizations. Donors must have sufficient information to understand the donation process with its risks and benefits, time to consider options before deciding, and opportunity to choose whether to proceed with or decline donating. The goal of this multisite randomized controlled trial was to evaluate knowledge acquired using standardized DnEM. America's Blood Centers' Working Group (WG) for Donor Education and Communication was formed to evaluate and suggest modifications of these documents. Based on pilot work, a randomized clinical trial was designed to test donor knowledge across a variety of populations. The WG identified several shortcomings in the current DnEM and proposed new DnEM. The new DnEM were tested against the same, current DnEM being used at all three sites (Blood Donor Educational Material, 2016 version 2.0, published in conjunction with the AABB uniform donor history questionnaire). METHODS AND MATERIALS One-hundred sixty-five first time and returning donors were randomized in a 2x2 model to review either new DnEM or current DnEM. Every participant completed a pre- and post-quiz that tested their understanding of the DnEM. RESULTS Returning donors had greater baseline knowledge compared to new donors, but new donors improved more versus returning donors. Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM. CONCLUSION Comprehension of DnEM can be improved. With this sample size the results suggest that the findings are independent of demographic characteristics, but a larger study would be necessary to confirm this.

Abstract

Background: Besides anemia, iron deficiency may cause more subtle symptoms, including the restless legs syndrome (RLS), the chronic fatigue syndrome (CFS) or sleeping disorders. Objective: The aim of this pre-planned secondary analysis of the IronWoMan randomized controlled trial (RCT) was to compare the frequency and severity of symptoms associated with iron deficiency before and after (intravenous or oral) iron supplementation in iron deficient blood donors. METHODS/DESIGN Prospective, randomized, controlled, single-centre trial. (ClinicalTrials.gov: NCT01787526). SETTING Tertiary care center in Graz, Austria. PARTICIPANTS 176 (138 female and 38 male) whole-blood and platelet apheresis donors aged ≥ 18 and ≤ 65 years with iron deficiency (ferritin ≤ 30ng/mL at the time of blood donation). INTERVENTIONS Intravenous iron (1 g ferric carboxymaltose, n = 86) or oral iron supplementation (10 g iron fumarate, 100 capsules, n = 90). MEASUREMENTS Clinical symptoms were evaluated by a survey before iron therapy (visit 0, V0) and after 8-12 weeks (visit 1, V1), including questions about symptoms of restless legs syndrome (RLS), chronic fatigue syndrome (CFS), sleeping disorders, quality of life and symptoms like headaches, dyspnoea, dizziness, palpitations, pica and trophic changes in fingernails or hair. RESULTS We found a significant improvement in the severity of symptoms for RLS, fatigue and sleep quality (p < 0.001). Furthermore, a significant decrease in headaches, dyspnoea, dizziness and palpitations was reported (p < 0.05). There was no difference between the type of iron supplementation (intravenous versus oral) and clinical outcome data. CONCLUSION Iron supplementation in iron-deficient blood donors may be an effective strategy to improve symptoms related to iron deficiency and the wellbeing of blood donors.

Abstract

BACKGROUND Recruiting of sufficient numbers of donors of blood products is vital worldwide. In this study we assessed the efficacy and cost-effectiveness of telephone calls and SMS reminders for re-recruitment of inactive blood donors. METHODS This single-centre, non-blinded, parallel randomised controlled trial in Guangzhou, China included 11,880 inactive blood donors whose last donation was between January 1 and June 30, 2014. The donors were randomly assigned to one of two intervention groups (telephone call or short message service [SMS] communications) or to a control group without intervention. SMS messages with altruistic appeal were adopted in the SMS group; in addition to altruistic appeal, reasons for deferral of blood donation were also asked in the telephone group. All participants were followed up for 1 year. The primary outcome was re-donation rate, and rates in different groups were compared by intention-to-treat (ITT) analysis and estimation of the average treatment effect on the treated (ATT). Secondary outcomes were the self-reported deterrents. Other outcomes included the re-donation interval, and the incremental cost-effectiveness ratio (ICER) of telephone calls and SMS reminders on re-recruitment. RESULTS ITT analysis revealed no significant differences in the re-donation rate among the three groups. ATT estimations indicated that among compliers, telephone calls significantly increased re-donation compared to both SMS reminders and no intervention. Donor return behaviour was positively associated with receiving reminders successfully, being male, older age, and previous donation history. The SMS reminder prompted donors to return sooner than no reminder within 6 months, and according to ICER calculations, SMS reminders were more cost-effective than telephone calls. Donors reported time constraints as the most main causes of self-deferral in the telephone group, and altruistic appeal had a positive effect on these donors. CONCLUSIONS Interventions to reactivate inactive blood donors can be effective, with telephone calls prompting more donors to return but at a greater cost than SMS messages. SMS reminder with altruistic appeal can urge donors to re-donate sooner within 6 months than no reminder. TRIAL REGISTRATION NCT03366441 (Reactivation of Inactive Blood Donors). Retrospectively registered 4 December 2017.