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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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2.
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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3.
Higher Risk of HEV Transmission and Exposure among Blood Donors in Europe and Asia in Comparison to North America: A Meta-Analysis
Wolski A, Pischke S, Ozga AK, Addo MM, Horvatits T
Pathogens (Basel, Switzerland). 2023;12(3)
Abstract
BACKGROUND AND AIMS The increasing number of diagnosed hepatitis E virus (HEV) infections in Europe has led to the implementation of the testing of blood products in various countries. Many nations have not yet implemented such screening. To assess the need for HEV screening in blood products worldwide, we conducted a systematic review and meta-analysis assessing HEV RNA positivity and anti-HEV seroprevalence in blood donors. METHODS Studies reporting anti-HEV IgG/IgM or HEV RNA positivity rates among blood donors worldwide were identified via predefined search terms in PubMed and Scopus. Estimates were calculated by pooling study data with multivariable linear mixed-effects metaregression analysis. RESULTS A total of 157 (14%) of 1144 studies were included in the final analysis. The estimated HEV PCR positivity rate ranged from 0.01 to 0.14% worldwide, with strikingly higher rates in Asia (0.14%) and Europe (0.10%) in comparison to North America (0.01%). In line with this, anti-HEV IgG seroprevalence in North America (13%) was lower than that in Europe (19%). CONCLUSIONS Our data demonstrate large regional differences regarding the risk of HEV exposure and blood-borne HEV transmission. Considering the cost-benefit ratio, this supports blood product screening in high endemic areas, such as Europe and Asia, in contrast to low endemic regions, such as the U.S.
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Knowledge and Barriers About Blood Donation and Associated Factors in Saudi Arabia: A Systematic Review
Alanazi, A. E., Almulla, B. R. F., Alanazi, S. M. S., Alshammari, S. K. M., Aldossary, A. A. A., Alanazi, S. G. M., Alenezi, R. A. S., Alanazi, T. M. B.
Cureus. 2023;15(11):e48506
Abstract
Transfusions and blood donations are relatively risk-free medical procedures. However, attitudes, beliefs, and knowledge levels about blood donation and transfusion may influence such operations. This systematic review aims to comprehensively investigate the level of knowledge and attitudes towards blood donation in Saudi Arabia. PubMed, Scopus, Web of Science, and ScienceDirect were systematically searched for relevant literature. Rayyan (Qatar Computing Research Institute, Ar-Rayyan, Qatar) was employed throughout this comprehensive process. This review included 17 studies with a total of 9,212 patients, and 4,806 (52.2%) were males. The majority of Saudis lacked awareness about blood donation and had unfavorable opinions towards it. In addition to various fears, mistrust, a lack of information, and not being approached by anyone to donate blood, participants reported that the distance to the donation site, the difficulty with transportation, the time commitment, getting a quick break from work or the office, or taking time off from home were also contributing to the negative attitudes towards blood donation. While youthful participants were more likely to contribute, Saudi university students in this study had inadequate information but positive attitudes about blood donation. Ineligibility, fear of giving blood, and inaccurate information regarding blood donation are the main deterrents to blood donation.
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Cost Effectiveness of Different Platelet Preparation, Storage, Selection and Dosing Methods in Platelet Transfusion: A Systematic Review
Laermans, J., Van Remoortel, H., Scheers, H., Avau, B., Georgsen, J., Nahirniak, S., Shehata, N., Stanworth, S. J., De Buck, E., Compernolle, V., et al
PharmacoEconomics - open. 2023
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Free full text
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Editor's Choice
Abstract
BACKGROUND AND OBJECTIVE Evidence-based guidelines on platelet transfusion therapy assist clinicians to optimize patient care, but currently do not take into account costs associated with different methods used during the preparation, storage, selection and dosing of platelets for transfusion. This systematic review aimed to summarize the available literature regarding the cost effectiveness (CE) of these methods. METHODS Eight databases and registries, as well as 58 grey literature sources, were searched up to 29 October 2021 for full economic evaluations comparing the CE of methods for preparation, storage, selection and dosing of allogeneic platelets intended for transfusion in adults. Incremental CE ratios, expressed as standardized cost (in 2022 EUR) per quality-adjusted life-year (QALY) or per health outcome, were synthesized narratively. Studies were critically appraised using the Philips checklist. RESULTS Fifteen full economic evaluations were identified. Eight investigated the costs and health consequences (transfusion-related events, bacterial and viral infections or illnesses) of pathogen reduction. The estimated incremental cost per QALY varied widely from EUR 259,614 to EUR 36,688,323. For other methods, such as pathogen testing/culturing, use of apheresis instead of whole blood-derived platelets, and storage in platelet additive solution, evidence was sparse. Overall, the quality and applicability of the included studies was limited. CONCLUSIONS Our findings are of interest to decision makers who consider implementing pathogen reduction. For other preparation, storage, selection and dosing methods in platelet transfusion, CE remains unclear due to insufficient and outdated evaluations. Future high-quality research is needed to expand the evidence base and increase our confidence in the findings.
PICO Summary
Population
Platelet transfusion recipients (15 full economic evaluations).
Intervention
Systematic review summarising the available literature regarding the cost effectiveness of different platelet preparation, storage, selection and dosing methods in platelet transfusion.
Comparison
Outcome
Eight studies investigated the costs and health consequences (transfusion-related events, bacterial and viral infections or illnesses) of pathogen reduction. The estimated incremental cost per quality-adjusted life-year varied widely from EUR 259,614 to EUR 36,688,323. For other methods, such as pathogen testing/culturing, use of apheresis instead of whole blood-derived platelets, and storage in platelet additive solution, evidence was sparse. Overall, the quality and applicability of the included studies was limited.
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Pathogen inactivation methods to prevent transfusion-transmissible arboviruses
Giménez-Richarte Á, Ortiz de Salazar MI, Giménez-Richarte MP, Larrea L, Arbona C, Marco P, Ramos-Rincón JM
Tropical medicine & international health : TM & IH. 2023
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Editor's Choice
Abstract
OBJECTIVE Arboviruses are emerging as a relevant threat to transfusion safety. Pathogen inactivation methods may reduce the risk of transmission through transfusion, as long as they meet minimum standards for effectiveness. This study aims to assess the log reduction of viral load achieved with different pathogen inactivation methods, according to the blood product they are used on and the arbovirus targeted. METHODS Systematic literature review and meta-analysis. Searches were conducted in MEDLINE and Embase. The study protocol was registered in PROSPERO CRD42022312061. We selected records reporting the log reduction of viral load achieved with the main pathogen inactivation methods (amotosalen + UVA light [INTERCEPT], riboflavin + UV light [Mirasol], methylene blue + visible light/UVC light [THERAFLEX], solvent detergent, amustaline [INTERCEPT] and PEN110 [Inactine]), applied to any blood product (plasma, platelets, red blood cells or whole blood) and for any arbovirus. The log reduction of viral loads was assessed by obtaining the mean log reduction factor (LRF). We compared and classified the LRF of different techniques using statistical methods. RESULTS We included 59 publications reporting LRF results in 17 arboviruses. For 13 arboviruses, including Chikungunya virus, Dengue virus, West Nile virus, and Zika virus, at least one of the methods achieves adequate or optimal log reduction of viral load - mean LRF ≥4. The LRF achieved with riboflavin + UV light is inferior to the rest of the techniques, both overall and specifically for plasma, platelets preserved in platelet additive solution (PAS)/plasma, and red blood cells/whole blood. The LRF achieved using Mirasol is also lower for inactivating chikungunya virus, dengue virus, and Zika virus. For West Nile virus, we found no significant differences. In plasma, the method that achieves the highest LRF is solvent/detergent; in platelets, THERAFLEX and INTERCEPT; and in red blood cells/whole blood, PEN110 (Inactine). CONCLUSION Not all pathogen inactivation methods achieve the same LRF, nor is this equivalent between the different arboviruses or blood products. Overall, the LRFs achieved using riboflavin + UV light (Mirasol) are inferior to those achieved with the rest of the pathogen inactivation methods. Regarding the others, LRFs vary by arbovirus and blood product. In light of the threat of different arboviruses, blood establishments should have already validated pathogen inactivation methods and be logistically prepared to implement these techniques quickly.
PICO Summary
Population
Whole blood or human blood products from blood donors (59 studies).
Intervention
Systematic literature review and meta-analysis assessing the log reduction of viral load achieved with different pathogen inactivation methods, according to the blood product they were used on and the arbovirus targeted.
Comparison
Outcome
The included studies reported log reduction factor (LRF) results in 17 arboviruses. For 13 arboviruses, including Chikungunya virus, Dengue virus, West Nile virus, and Zika virus, at least one of the methods achieved adequate or optimal log reduction of viral load - mean LRF ≥4. The LRF achieved with riboflavin + UV light was inferior to the rest of the techniques, both overall and specifically for plasma, platelets preserved in platelet additive solution (PAS)/plasma, and red blood cells/whole blood. The LRF achieved using Mirasol was also lower for inactivating Chikungunya virus, Dengue virus, and Zika virus. For West Nile virus, no significant differences were found. In plasma, the method that achieved the highest LRF was solvent/detergent; in platelets, THERAFLEX and INTERCEPT; and in red blood cells/whole blood, PEN110 (Inactine).
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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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Free full text
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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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Effect of large volume red blood cell apheresis on cardiovascular functions in healthy donors
Chen, Q., Chen, G. Y., Chen, J. M., Yang, F. F., Han, Y., Wang, L. H., Wu, J. H., Ji, D. D., Yuan, S. Q., Zhang, M. Q., et al
European journal of clinical investigation. 2023;:e14047
Abstract
BACKGROUND Requirements of blood transfusions rise rapidly in China. Improving the efficiency of blood donation could help maintaining sufficient blood supplement. We conducted a pilot research to investigate the reliability and safety of collecting more units of red blood cell by apheresis. METHODS Thirty-two healthy male volunteers were randomized into two groups: red blood cell apheresis (RA) (n = 16) and whole blood (WB) donation (n = 16). RA group donated individualized RBC volumes by apheresis according to the volunteers' basal total blood volumes and haematocrit levels, WB group donated 400 mL whole blood. All volunteers were scheduled seven visit times in 8 weeks' study period. The cardiovascular functions were assessed by laboratory examinations, echocardiography and cardiopulmonary functional tests. All results were compared between groups at the same visit time and compared between visit 1(before donation) and other visit times within the same group. RESULTS The average donated RBC volume in RA group and in WB group was 627.25 ± 109.74 mL and 175.28 ± 8.85 mL, respectively(p < 0.05); the RBC, haemoglobin and haematocrit levels changed significantly between times and between groups (p < 0.05). Cardiac biomarker levels such as NT-proBNP, hs-TnT and CK-MB did not change significantly between times or between groups (p > 0.05). The echocardiographic and cardiopulmonary results did not change significantly between times or between groups during the whole study period(p > 0.05). CONCLUSIONS We provided an efficient and secure method for RBC apheresis. By harvesting more RBC volumes at one single-time, the cardiovascular functions did not change significantly compared with traditional whole blood donation.
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A randomized controlled trial of post-donation communication materials to increase donor return following a vasovagal reaction
Thijsen, A., Gemelli, C. N., Davison, T. E., Masser, B.
Transfusion. 2023
Abstract
BACKGROUND Vasovagal reactions (VVRs) are one of the primary reasons for people to stop donating blood. The aim of this study was to evaluate the impact of newly developed online communications on the rate of return of whole-blood (WB) and plasma donors who experienced a VVR. STUDY DESIGN AND METHODS First-time and experienced WB and plasma donors who had a VVR without a loss of consciousness in the previous 3 days were randomly allocated to receive (a) an SMS sent 1-4 days post-VVR (n = 2303), (b) an email sent 6-10 days post-VVR (n = 2360), (c) both the SMS and the email (n = 2248), or (d) business-as-usual donor retention communications (control; n = 2557). Donation data were extracted to determine subsequent donation attempts. RESULTS For return within 3 months, WB donors in the Email Only condition had significantly increased odds of returning (OR: 1.26, 95%CI: 1.01-1.56). Subgroup analysis within WB donors showed increased odds of return for women sent the SMS and Email (OR: 1.50, 95%CI: 1.14-1.96) or the Email Only (OR: 1.44, 95%CI: 1.10-1.89), and for first-time donors sent the Email Only (OR: 1.48, 95%CI: 1.07-2.05). At 6 months, only first-time WB donors in the Email Only condition had significantly increased odds of returning (OR: 1.30, 95%CI: 1.01-1.69). No significant effects of the intervention were found for immediate or intermediate return for plasma donors. DISCUSSION Sending an email addressing common donor concerns regarding VVRs increases WB donor retention, but additional strategies are needed for the effects to last and to retain plasma donors.
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Systematic review of prevalence and risk factors of transfusion transmissible infections among blood donors, and blood safety improvements in Southern Africa
Puerto-Meredith, S., Singogo, E., Chagomerana, M., Nthani, T., Likaka, A., Gondwe, A., M'Baya, B., Hosseinipour, M. C.
Transfusion medicine (Oxford, England). 2023
Abstract
Blood and blood products are listed as one of the essential medicines by the World Health Organization (WHO). In addition to inadequate supply, most sub-Saharan Africa (SSA) nations fail to meet their blood needs because many donated blood units are discarded because they are contaminated with transfusion-transmitted infections (TTIs). We sought to estimate the prevalence of TTIs, identify the risk factors for TTIs among blood donors, and identify the efforts and interventions that have been made to improve blood safety in Southern African nations, particularly the nations of the South African Development Community (SADC). We investigated the prevalence and risk factors for TTIs, blood safety interventions, and blood quality improvement in the SADC region from major PubMed/MEDLINE, Cochrane Library, and HINARI databases from 1 January 2011 to 31 April 2021. All investigations followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). In meta-analysis, we estimated the pooled TTIs prevalence and summarised the same using forest plots. A total of 180 articles published from the SSA region were identified covering our three targeted themes: TTI prevalence, risk factors for TTIs, and blood safety improvements. Of these 180 articles, only 27 (15%) focused on the SADC region. The overall pooled TTI prevalence estimate was 2.0% (95% CI: 1.0-3.0) and hepatitis B was the most prevalent TTI in the region (prevalence = 3.0; 95% CI: 2.0-5.0). The prevalence of HIV, HCV, and syphilis was 2.0% (95% CI: 1.0-4.0), 1.0% (95% CI: 0.0-2.0), and 2.0% (95% CI: 0.0-8.0), respectively. In general, replacement donors and first-time donors were more likely to be infected with TTIs than repeat donors. Twelve articles explored blood safety research in the region; however, they vary greatly highlighting the need for consistent and more comprehensive research. Few publications were identified that were from the SADC region, indicating lack of research or resources towards improving both quantity and quality of blood donation. TTI prevalence remains one of the highest in the world and blood safety recommendations vary across the region. More effort should be directed towards developing a cohesive regional blood transfusion policy and effective blood monitoring and evaluation strategies.