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Prevention strategies for vasovagal reaction in whole blood donors: A quadri-armed randomised control trial
Meher, R., Patidar, G. K., Chaurasia, R., Pandey, H. C., Hazarika, A.
Transfusion medicine (Oxford, England). 2024
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Editor's Choice
Abstract
INTRODUCTION Vasovagal reaction (VVR) is a frequently encountered generalised donor adverse reaction, associated with donor deterrence towards future donation. Several mitigation strategies for prevention of VVR were tried but still not standardised. This quadri-armed randomised study evaluated the utility of water ingestion, applied muscle tension (AMT) and combination of both in preventing the VVR among blood donors. METHODS A quadri-armed randomised controlled trial was performed on 4320 whole blood donors. Blood donors of 18-65 years of age were randomised into four groups based on the interventions performed i.e., control with no intervention (Group 1, n = 1081), water ingestion (Group 2, n = 1082), AMT (Group 3, n = 1070) and combined intervention (Group 4, n = 1087). VVR during and immediately after blood donation were observed along with assessment of risk factors in blood donors and the effectiveness of interventions were analysed. RESULTS The incidence of VVR observed 1.6% in our study, with the highest occurrence in the control group (2.5%) and the lowest in the combined intervention group (0.9%). Multivariable logistic regression revealed that the control group donors faced a 1.38-fold greater risk of VVR compared to those receiving interventions (OR: 1.38, 95% CI: 1.10-1.75). Other risk factors included younger age (OR: 1.5, 95% CI: 1.05-2.17), first-time donation (OR: 5.7, 95% CI: 1.66-5.74), prior history of VVR (OR: 2.5, 95% CI: 10.4-101.52). DISCUSSION/CONCLUSION The combined approach of water ingestion and AMT proved significantly more effective in VVR prevention compared to individual interventions.
PICO Summary
Population
Whole blood donors (n= 4,320).
Intervention
Water ingestion (n= 1,082). Applied muscle tension (AMT), (n= 1,070). Combination of water ingestion and AMT (combined intervention group, n= 1,087).
Comparison
No intervention (control group, n= 1,081).
Outcome
The incidence of vasovagal reaction (VVR) was 1.6%, with the highest occurrence in the control group (2.5%) and the lowest in the combined intervention group (0.9%). Multivariable logistic regression revealed that the control group donors faced a 1.38-fold greater risk of VVR compared to those receiving interventions (OR 1.38; 95% CI [1.10, 1.75]). Other risk factors included younger age (OR 1.5; 95% CI [1.05, 2.17]), first-time donation (OR 5.7; 95% CI [1.66, 5.74]), and prior history of VVR (OR 2.5; 95% CI [10.4, 101.52]).
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Effects of plasmapheresis frequency on health status and exercise performance in men: A randomized controlled trial
Mortier, A., Khoudary, J., van Dooslaer de Ten Ryen, S., Lannoy, C., Benoit, N., Antoine, N., Copine, S., Van Remoortel, H., Vandekerckhove, P., Compernolle, V., et al
Vox sanguinis. 2023
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Editor's Choice
Abstract
BACKGROUND AND OBJECTIVES Most research studies on the effects of repeated plasma donation are observational with different study limitations, resulting in high uncertainty on the link between repeated plasma donation and health consequences. Here, we prospectively investigated the safety of intensive or less intensive plasma donation protocols. MATERIALS AND METHODS Sixty-three male subjects participated in this randomized controlled trial and were divided into low-frequency (LF, once/month, n = 16), high-frequency (HF, three times/month, n = 16), very high-frequency (VHF, two times/week, n = 16) and a placebo (P, once/month, n = 15) groups. Biochemical, haematological, clinical, physiological and exercise-related data were collected before (D0), after 1½ months (D42) and after 3 months (D84) of donation. RESULTS In VHF, red blood cells, haemoglobin and haematocrit levels decreased while reticulocyte levels increased from D0 to D84. In both HF and VHF, plasma ferritin levels were lower at D42 and D84 compared to D0. In VHF, plasma levels of albumin, immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM) dropped from D0 to D42 and remained lower at D84 than at D0. In HF, plasma IgG, IgA and IgM were lower at D42, and IgG and IgM were lower at D84, compared to D0. Few adverse events were reported in HF and VHF. Repeated plasma donation had no effect on blood pressure, body composition or exercise performance. CONCLUSION VHF plasmapheresis may result in a large reduction in ferritin and IgG levels. HF and VHF plasmapheresis may result in little to no difference in other biochemical, haematological, clinical, physiological and exercise-related parameters.
PICO Summary
Population
Plasmapheresis donors (n= 63).
Intervention
One plasma donation per month (low-frequency (LF) n= 16).
Comparison
Three plasma donations per month (high-frequency (HF) n= 16). Two plasma donations per week (very high-frequency (VHF) n= 16). Placebo (n= 15).
Outcome
Biochemical, haematological, clinical, physiological and exercise-related data were collected before (D0), after one and a half months (D42) and after 3 months (D84) of donation. In VHF, red blood cells, haemoglobin and haematocrit levels decreased while reticulocyte levels increased from D0 to D84. In both HF and VHF, plasma ferritin levels were lower at D42 and D84 compared to D0. In VHF, plasma levels of albumin, immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM) dropped from D0 to D42 and remained lower at D84 than at D0. In HF, plasma IgG, IgA and IgM were lower at D42, and IgG and IgM were lower at D84, compared to D0. Few adverse events were reported in HF and VHF. Repeated plasma donation had no effect on blood pressure, body composition or exercise performance.
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Evaluation of interventions to prevent vasovagal reactions among whole blood donors: rationale and design of a large cluster randomised trial
McMahon, A., Kaptoge, S., Walker, M., Mehenny, S., Gilchrist, P. T., Sambrook, J., Akhtar, N., Sweeting, M., Wood, A. M., Stirrups, K., et al
Trials. 2023;24(1):512
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Editor's Choice
Abstract
BACKGROUND Vasovagal reactions (VVRs) are the most common acute complications of blood donation. Responsible for substantial morbidity, they also reduce the likelihood of repeated donations and are disruptive and costly for blood services. Although blood establishments worldwide have adopted different strategies to prevent VVRs (including water loading and applied muscle tension [AMT]), robust evidence is limited. The Strategies to Improve Donor Experiences (STRIDES) trial aims to reliably assess the impact of four different interventions to prevent VVRs among blood donors. METHODS STRIDES is a cluster-randomised cross-over/stepped-wedge factorial trial of four interventions to reduce VVRs involving about 1.4 million whole blood donors enrolled from all 73 blood donation sites (mobile teams and donor centres) of National Health Service Blood and Transplant (NHSBT) in England. Each site ("cluster") has been randomly allocated to receive one or more interventions during a 36-month period, using principles of cross-over, stepped-wedge and factorial trial design to assign the sequence of interventions. Each of the four interventions is compared to NHSBT's current practices: (i) 500-ml isotonic drink before donation (vs current 500-ml plain water); (ii) 3-min rest on donation chair after donation (vs current 2 min); (iii) new modified AMT (vs current practice of AMT); and (iv) psychosocial intervention using preparatory materials (vs current practice of nothing). The primary outcome is the number of in-session VVRs with loss of consciousness (i.e. episodes involving loss of consciousness of any duration, with or without additional complications). Secondary outcomes include all in-session VVRs (i.e. with and without loss of consciousness), all delayed VVRs (i.e. those occurring after leaving the venue) and any in-session non-VVR adverse events or reactions. DISCUSSION The STRIDES trial should yield novel information about interventions, singly and in combination, for the prevention of VVRs, with the aim of generating policy-shaping evidence to help inform blood services to improve donor health, donor experience, and service efficiency. TRIAL REGISTRATION ISRCTN 10412338. Registration date: October 24, 2019.
PICO Summary
Population
Whole blood donors enrolled in the Strategies to Improve Donor Experiences (STRIDES) trial from all 73 blood donation sites of National Health Service Blood and Transplant (NHSBT) in England (n= 1.4 million).
Intervention
(i) 500ml isotonic drink before donation; (ii) 3-min rest on donation chair after donation; (iii) New modified applied muscle tension (AMT); (iv) Psychosocial intervention using preparatory materials upon arrival and registration.
Comparison
NHSBT’s current practices: (i) 500ml plain water before donation. (ii) 2-min rest on donation chair after donation; (iii) Current practice of AMT; (iv) No psychosocial intervention.
Outcome
The primary outcome is the number of in-session vasovagal reactions (VVRs) with loss of consciousness. Secondary outcomes include all in-session VVRs, all delayed VVRs and any in-session non-VVR adverse events or reactions. Each site ("cluster") has been randomly allocated to receive one or more interventions during a 36-month period, using principles of cross-over, stepped-wedge and factorial trial design to assign the sequence of interventions. Researchers will test the hypothesis that that the implementation of one or more interventions, singly or in combination, will reduce VVRs when compared to current practice in NHSBT.
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Hepatitis C virus screening reactive among blood donors in mainland China: A systematic review and meta-analysis
Zhou Q, Liu A, Wang S, Li J, He M, Chen L
Transfusion medicine (Oxford, England). 2022
Abstract
BACKGROUND Hepatitis C virus (HCV) can be transmitted by blood transfusion. The aim of this meta-analysis is to estimate the anti-HCV reactive rate and to define the demographic characteristics of blood donors who have potential threats to blood safety in mainland China for nearly 30 years, in order to provide a safe reference for blood transfusion and corresponding guidance for policymakers to increase blood safety. MATERIALS AND METHODS Literature reporting the anti-HCV screening reactive rate in Chinese blood donors was identified by systematic searching of four electronic databases from 1991 to 2017. The Preferred Reporting of Items for Systematic Reviews and Meta-Analyses guidelines were strictly followed, and data manipulation and statistical analysis were performed by Stata 15.0. RESULTS Our results showed that the post-donation anti-HCV reactive rate was 0.53% (95% confidence interval [CI], 0.51%-0.55%) with a significant variation from 1.58% (95% CI, 1.13%-2.03%) before 1998 to 0.51% (95% CI, 0.48%-0.53%) after 1998 when the Blood Donation Law was implemented in China. In addition, anti-HCV screening reactive rate for family or replacement donors was significantly higher than that in individual voluntary blood donors. CONCLUSION Our results indicated that blood centres in China should convert more eligible first-time donors into repeat donors and turn the 'real family or replacement donors' into individual voluntary blood donors to reduce the risk of transfusion-transmitted HCV. In the meantime, large surveys should be carried out among volunteer donors from high-risk populations.
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Prevention of Blood Donation-related Vasovagal Response by Applied Muscle Tension: a Meta-analysis
Wang, C., Chen, L., Sun, C., Zhang, Y., Cao, C., Ma, Y., Shi, W.
The Journal of International Medical Research. 2022;50(9):3000605221121958
Abstract
OBJECTIVE Vasovagal reaction (VVR) is an adverse reaction to blood donation. Applied muscle tension (AMT) has been reported to reduce the probability of VVR during blood donation; however, the results have been controversial. We therefore conducted a meta-analysis to systematically evaluate the effect of AMT in reducing VVR. METHODS We searched six major databases using "applied muscle tension" and "blood donation-related vasovagal response" as keywords. Relevant articles published in English or Chinese between 1 January 2000 and 30 June 2021 were included in the analysis. The quality of the included articles was evaluated and publication bias was assessed by forest and funnel plots and by Egger's test. RESULTS Fifty-one articles were identified, of which six were included according to the pre-defined inclusion and exclusion criteria. A fixed-effects model was adopted for effect size combination and revealed a relative risk of 0.52 (95% confidence interval 0.40 to 0.67). The AMT group was superior to the control in terms of VVR prevention. A funnel plot and Egger's test suggested that the findings were accurate and reliable with low publication bias. CONCLUSION AMT could effectively reduce VVR during blood donation. Further multicenter studies with large sample sizes are needed to confirm these results.
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Global epidemiology of occult hepatitis B virus infections in blood donors, a systematic review and meta-analysis
Takuissu, G. R., Kenmoe, S., Amougou Atsama, M., Atenguena Okobalemba, E., Mbaga, D. S., Ebogo-Belobo, J. T., Bowo-Ngandji, A., Oyono, M. G., Magoudjou-Pekam, J. N., Kame-Ngasse, G. I., et al
PloS one. 2022;17(8):e0272920
Abstract
This study aimed to assess the global prevalence of occult hepatitis B in blood donors. We searched PubMed, Web of Science, Global Index Medicus, and Excerpta Medica Database. Study selection and data extraction were performed by at least two independent investigators. Heterogeneity (I2) was assessed using the χ2 test on the Cochran Q statistic and H parameters. Sources of heterogeneity were explored by subgroup analyses. This study is registered with PROSPERO, number CRD42021252787. We included 82 studies in this meta-analysis. The overall prevalence of OBI was 6.2% (95% CI: 5.4-7.1) in HBsAg negative and anti-HBc positive blood donors. Only sporadic cases of OBI were reported in HBsAg negative and anti-HBc negative blood donors. The overall prevalence of OBI was 0.2% (95% CI: 0.1-0.4) in HBsAg negative blood donors. The prevalence of OBI was generally higher in countries with low-income economic status. The results of this study show that despite routine screening of blood donors for hepatitis B, the transmission of HBV by blood remains possible via OBI and/or a seronegative window period; hence there is a need for active surveillance and foremost easier access to molecular tests for the screening of blood donors before transfusion.
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Cardiovascular Benefits for Blood Donors? A Systematic Review
Quee FA, Peffer K, Ter Braake AD, Van den Hurk K
Transfusion medicine reviews. 2022
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Editor's Choice
Abstract
It has been proposed that blood donation could be protective against cardiovascular disease. The aim of this study is to systematically summarize and evaluate existing observational and experimental studies on effects of blood donation on cardiovascular risk and disease in donor and general populations. The electronic databases PubMed and EMBASE were searched until March 2019 for experimental and observational studies on blood donation and cardiovascular risk or disease. Excluded were studies performed in patient populations or with controls compared to a patient population, and studies performed in individuals aged <18 or >70. All identified studies were independently screened for eligibility and quality using validated scoring systems by 2 reviewers. A total of 44 studies met all criteria. We included 41 observational studies and 3 experimental studies. 14 studies had a quality assessment score of 7 or higher. Of those, a majority of 9 studies reported a protective effect of blood donation, while 5 studies found no effects on cardiovascular risk factors. Results on other various outcomes were inconsistent and study quality was generally poor. Whether or not blood donation protects against cardiovascular disease remains unclear. Studies showing beneficial effects may have inadequately dealt with the healthy donor effect. High quality studies are lacking and therefore definite conclusions cannot be drawn. Large RCTs or cohort studies of high quality with sufficient follow-up should be conducted to provide evidence on the possible association between blood donation and cardiovascular disease.
PICO Summary
Population
Blood donors (41 observational studies and 3 experimental studies).
Intervention
Systematic review to summarize and evaluate existing observational and experimental studies on effects of blood donation on cardiovascular risk and disease in donor and general populations.
Comparison
Outcome
From the 44 included studies, 14 had a quality assessment score of 7 or higher. Of those, a majority of 9 studies reported a protective effect of blood donation, while 5 studies found no effects on cardiovascular risk factors. Results on other outcomes were inconsistent and study quality was generally poor. It was unclear whether blood donation protected against cardiovascular disease. High quality studies were lacking.
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Effect of Plasma and Blood Donations on Levels of Perfluoroalkyl and Polyfluoroalkyl Substances in Firefighters in Australia: A Randomized Clinical Trial
Gasiorowski R, Forbes MK, Silver G, Krastev Y, Hamdorf B, Lewis B, Tisbury M, Cole-Sinclair M, Lanphear BP, Klein RA, et al
JAMA network open. 2022;5(4):e226257
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Editor's Choice
Abstract
IMPORTANCE Elevated levels of blood perfluoroalkyl and polyfluoroalkyl substances (PFASs) have been associated with a range of adverse health outcomes. Firefighters have been exposed to PFASs in firefighting foams and have previously been shown to have higher PFAS levels in blood samples than the general population. No interventions have been shown to reduce PFAS levels. OBJECTIVE To examine the effect of blood or plasma donations on PFAS levels in firefighters in Australia. DESIGN, SETTING, AND PARTICIPANTS This 52-week, open-label, randomized clinical trial enrolled participants from May 23 to August 23, 2019. Participants were 285 Fire Rescue Victoria staff or contractors with serum levels of perfluorooctane sulfonate (PFOS) of 5 ng/mL or more who were eligible to donate blood, had not donated blood in the 3 months prior to randomization, and were able to provide written informed consent. Analysis was performed on an intention-to-treat basis from May to July 2021. INTERVENTIONS Firefighters with baseline PFOS levels of 5 ng/mL or more were randomly assigned to donate plasma every 6 weeks for 12 months, donate blood every 12 weeks for 12 months, or be observed only. MAIN OUTCOMES AND MEASURES The primary end points were changes in the serum PFOS and perfluorohexane sulfonic acid (PFHxS) levels after 12 months of plasma or blood donations or after observation only. Secondary end points included changes in serum PFAS levels from week 52 to week 64, changes in other PFASs, and changes in complete blood count, biochemistry, thyroid function, and lipid profile from screening to week 52. RESULTS A total of 285 firefighters (279 men [97.9%]; mean [SD] age, 53.0 [8.4] years) were enrolled; 95 were randomly assigned to donate plasma, 95 were randomly assigned to donate blood, and 95 were randomly assigned to be observed. The mean level of PFOS at 12 months was significantly reduced by plasma donation (-2.9 ng/mL; 95% CI, -3.6 to -2.3 ng/mL; P < .001) and blood donation (-1.1 ng/mL; 95% CI, -1.5 to -0.7 ng/mL; P < .001) but was unchanged in the observation group. The mean level of PFHxS was significantly reduced by plasma donation (-1.1 ng/mL; 95% CI, -1.6 to -0.7 ng/mL; P < .001), but no significant change was observed in the blood donation or observation groups. Analysis between groups indicated that plasma donation had a larger treatment effect than blood donation, but both were significantly more efficacious than observation in reducing PFAS levels. CONCLUSIONS AND RELEVANCE Plasma and blood donations caused greater reductions in serum PFAS levels than observation alone over a 12-month period. Further research is needed to evaluate the clinical implications of these findings. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12619000204145.
PICO Summary
Population
Firefighters with baseline serum levels of perfluorooctane sulfonate (PFOS) of 5 ng/mL or more (n= 285).
Intervention
Assigned to donate plasma every 6 weeks for 12 months (n= 95).
Comparison
Assigned to donate blood every 12 weeks for 12 months (n= 95). Assigned to be observed (n= 95).
Outcome
The primary end points were changes in the serum PFOS and perfluorohexane sulfonic acid (PFHxS) levels after 12 months. The mean level of PFOS at 12 months was significantly reduced by plasma donation (-2.9 ng/mL, 95% CI [-3.6, -2.3 ng/mL]), and blood donation (-1.1 ng/mL, 95% CI [-1.5, -0.7 ng/mL]) but was unchanged in the observation group. The mean level of PFHxS was significantly reduced by plasma donation (-1.1 ng/mL, 95% CI [-1.6, -0.7 ng/mL]), but no significant change was observed in the blood donation or observation groups. Analysis between groups indicated that plasma donation had a larger treatment effect than blood donation, but both were significantly more efficacious than observation in reducing PFAS levels.
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A randomized trial of blood donor iron repletion on red cell quality for transfusion and donor cognition and wellbeing
Hod EA, Brittenham GM, Bitan ZC, Feit Y, Gaelen JI, La Carpia F, Sandoval LA, Zhou AT, Soffing M, Mintz A, et al
Blood. 2022
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Editor's Choice
Abstract
Although altruistic regular blood donors are vital for the blood supply, many become iron deficient from donation-induced iron loss. The effects of blood donation-induced iron deficiency on red cell transfusion quality or donor cognition are unknown. In this double-blind, randomized trial, adult iron-deficient blood donors (n=79; ferritin <15 mg/L, and zinc protoporphyrin >60 mMol/mol heme) who met donation qualifications were enrolled. A first standard blood donation was followed by the gold-standard measure for red cell storage quality: a 51-chromium post-transfusion red cell recovery study. Donors were then randomized to intravenous iron repletion (one-gram low molecular weight iron dextran) or placebo. A second donation approximately five months later was followed by another recovery study. Primary outcome was the within-subject change in post-transfusion recovery. The primary outcome measure of an ancillary study reported here was the National Institutes of Health (NIH) Toolbox-derived uncorrected standard Cognition Fluid Composite Score. Overall, 983 donors were screened; 110 were iron-deficient and, of these, 39 were randomized to iron repletion and 40 to placebo. Red cell storage quality was unchanged by iron repletion: mean change in post-transfusion recovery was 1.6% (95% CI -0.5 - 3.8) and -0.4% (-2.0 - 1.2) with and without iron, respectively. Iron repletion did not affect any cognition or wellbeing measures. These data provide evidence that current criteria for blood donation preserve red cell transfusion quality for the recipient and protect adult donors from measurable effects of blood donation-induced iron deficiency on cognition. This trial was registered at www.clinicaltrials.gov as NCT02889133 and NCT02990559.
PICO Summary
Population
Adult iron-deficient blood donors enrolled in the Donor Iron Deficiency Study (DIDS), (n= 79).
Intervention
Intravenous iron repletion (n= 39).
Comparison
Placebo (n= 40).
Outcome
A first standard blood donation was followed by the gold-standard measure for red cell storage quality: a 51-chromium post-transfusion red cell recovery study. Donors were then randomized. A second donation approximately five months later was followed by another recovery study. Primary outcome was the within-subject change in post-transfusion recovery. The primary outcome measure was the National Institutes of Health (NIH) Toolbox-derived uncorrected standard Cognition Fluid Composite Score. Overall, 983 donors were screened; 110 were iron-deficient and, of these, 39 were randomized to iron repletion and 40 to placebo. Red cell storage quality was unchanged by iron repletion: mean change in post-transfusion recovery was 1.6% (95% CI -0.5 - 3.8) and -0.4% (-2.0 - 1.2) with and without iron, respectively. Iron repletion did not affect any cognition or wellbeing measures.
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Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors: A Randomized Controlled Trial
Basak, T., Aciksoz, S., Savasci, U., Yilmaz, S.
Journal of Infusion Nursing : The Official Publication of the Infusion Nurses Society. 2021;44(6):339-345
Abstract
The aim of this single-blinded, randomized controlled study was to determine the effectiveness of vapocoolant spray in reducing pain related to venipuncture in young, healthy male blood donors. The participants were separated into 2 groups by randomization. The donors in the control group (n = 44) were not given any intervention during the blood collection process. Vapocoolant spray was applied to the donors in the vapocoolant spray group (n = 44). The pain score was 1.90 ± 1.47 for the vapocoolant spray group and 3.23 ± 2.21 for the control group, and the difference between the groups was found to be statistically significant (P = .02). The study result showed that the use of vapocoolant spray for pain management is an effective method of reducing pain related to venipuncture during the process of blood donation in young male donors.