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Current advances in transfusion medicine 2020: A critical review of selected topics by the AABB Clinical Transfusion Medicine Committee
Elizabeth s. allen.
1 Department of Pathology, University of California San Diego, La Jolla, California, USA
Claudia S. Cohn
2 Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA
Sara Bakhtary
3 Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA
Nancy M. Dunbar
4 Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
Thomas Gniadek
5 Department of Pathology, NorthShore University Health System, Chicago, Illinois, USA
Courtney K. Hopkins
6 Vitalant, Scottsdale, Arizona, USA
Jessica Jacobson
7 Department of Pathology, New York University Grossman School of Medicine, New York, New York, USA
Parvez M. Lokhandwala
8 American Red Cross, Biomedical Services, Baltimore, Maryland, USA
9 Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Ryan A. Metcalf
10 Clinical Pathology Division, Department of Pathology, University of Utah, Salt Lake City, Utah, USA
Colin Murphy
11 Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA
Micah T. Prochaska
12 Department of Medicine, University of Chicago, Chicago, Illinois, USA
Jay S. Raval
13 Department of Pathology, University of New Mexico, Albuquerque, New Mexico, USA
14 Department of Pathology, Stanford University, Stanford, California, USA
Emily K. Storch
15 Office of Blood Research and Review, Food and Drug Administration, Silver Spring, Maryland, USA
Monica B. Pagano
16 Transfusion Medicine Division, Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA
Background:
The AABB Clinical Transfusion Medicine Committee (CTMC) compiles an annual synopsis of the published literature covering important developments in the field of transfusion medicine (TM), which has been made available as a manuscript published in Transfusion since 2018.
CTMC committee members reviewed original manuscripts including TM-related topics published electronically (ahead) or in print from December 2019 to December 2020. The selection of topics and manuscripts was discussed at committee meetings and chosen based on relevance and originality. Next, committee members worked in pairs to create a synopsis of each topic, which was then reviewed by two additional committee members. The first and senior authors of this manuscript assembled the final manuscript. Although this synopsis is extensive, it is not exhaustive, and some papers may have been excluded or missed.
The following topics are included: COVID-19 effects on the blood supply and regulatory landscape, COVID convalescent plasma, adult transfusion practices, whole blood, molecular immunohematology, pediatric TM, cellular therapy, and apheresis medicine.
Conclusions:
This synopsis provides easy access to relevant topics and may be useful as an educational tool.
1 |. INTRODUCTION
The Clinical Transfusion Medicine Committee (CTMC) of the AABB was charged by its Board of Directors to write an annual review of significant developments in transfusion medicine (TM). The committee chose topics based on new developments in the field and/or recent interest within the transfusion community; however, not all topics could be covered. Medical literature for the year 2020 was dominated by the pandemic caused by the novel coronavirus SARS-CoV-2 (COVID-19), and although the majority of publications this year focused on COVID-19, other important developments occurred in areas such as adult and pediatric transfusion practices, molecular immunohematology, cellular therapy, and therapeutic apheresis.
2 |. MATERIALS AND METHODS
CTMC members chose topics that were of significant interest and/or had high-impact developments. For each topic, an attempt was made to cover all literature published in English, scour news bulletins, and in some cases, solicit expert input to select manuscripts that the committee members considered notable in the field; however, this was not a systematic review of the literature, and the risk of bias and strength of the evidence were not addressed. After committee consensus regarding which manuscripts to include, committee members with expertise in that field wrote a synopsis of the literature. These synopses were reviewed by two to three other committee members, and the final manuscript content is reviewed and assembled by the first and last authors of this manuscript.
3 |. COVID-19: EFFECTS ON THE BLOOD SUPPLY AND REGULATORY LANDSCAPE
- The 2020 pandemic impacted the supply and demand for blood components and led to temporary and permanent changes by the U.S. Food & Drug Administration (FDA) in blood donor eligibility criteria.
When the World Health Organization declared the pandemic a national emergency, there was an initial reduction in blood collections of approximately 30% due to canceled blood drives. 1 , 2 This decreased supply was matched by a decreased demand as surgeries were canceled. 2 Since the initial decline, there have been sporadic, geographical shortages in the blood supply secondary to an increase in COVID cases along with weather events.
In response to the pandemic, the FDA provided guidance that included revising the donor eligibility criteria. 3 , 4 In April 2020, the FDA released the guidance “Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency” to address the urgent need for blood during the public health emergency. 4 The FDA also released guidance on reduced deferral periods and policies relating to human immunodeficiency virus (HIV) risk (August 2020), transfusion-transmitted malaria (April 2020), and revised recommendations regarding Creutzfeldt–Jakob Disease and Variant Creutzfeldt–Jakob Disease (August 2020) ( Table 1 ). 5 – 7
Select changes by the US Food & Drug Administration in donor deferral criteria designed to reduce the risk of transmission of infectious diseases
Infectious disease | Donor category | Previous deferral | Current deferral |
---|---|---|---|
HIV | Has exchanged sex for money or drugs | Indefinite | 3 months |
Non-prescription injection drug use | Indefinite | 3 months | |
History of receiving allogeneic transfusion | 12 months | 3 months | |
Nonsterile skin penetration with equipment contaminated with allogeneic blood or body fluids (e.g. needlestick) | 12 months | 3 months | |
Men who have had sex with men | 12 months | 3 months | |
Sexual contact with a person who has tested positive for HIV, or is at high risk of HIV infection (MSM, individuals who have exchanged money/drugs for sex, individuals who used non-prescription injection drugs) | 12 months | 3 months | |
Malaria | Travel to a malaria-endemic area | 12 months | 3 months |
CJD and variant CJD | Has a blood relative diagnosed with familial CJD | Indefinite | Permanent |
Abbreviations: CJD, Creutzfeldt–Jakob Disease; HIV, human immunodeficiency virus; MSM, men who have sex with men.
SARS-CoV-2 has been investigated for transmissibility by blood transfusion, and studies have demonstrated that the risk of transfusion-transmission is negligible. 8 , 9 The REDS Epidemiology, Surveillance, and Preparedness of the Novel SARS-CoV-2 Epidemic (RESPONSE) study is evaluating the incidence of SARS-CoV-2 RNA in asymptomatic blood donors and seroincidence of SARS-CoV-2 in blood donors to assist in epidemiologic and longitudinal studies of SARS-CoV-2. 10
4 |. COVID CONVALESCENT PLASMA
- Blood centers manufactured and distributed COVID-19 convalescent plasma (CCP) under investigation of new drug (IND) applications, expanded access programs (EAP), and emergency use authorization (EUA) for use in COVID-19 patients and also performed SARS-2-CoV IgG antibody testing on blood donors for seroprevalance studies and to qualify donors for CCP collection.
- Despite widespread CCP use, its efficacy remains controversial, with possible benefit shown for high titer CCP used early in course of disease.
- A major limitation to evaluating CCP efficacy has been widespread use outside of randomized control trials in the US.
- Heterogeneity in CCP antibody measurement and recipient selection remains challenges.
4.1 |. Access and regulatory guidance
As convalescent plasma for the treatment of COVID-19 has not yet been approved for use in the U.S., FDA guidance 11 confirmed that it is regulated as an investigational product and administered under IND or EUA; the latter continues to be updated as evidence emerges. 11 During spring 2020, the Mayo Clinic-led National Expanded Access Program (EAP) provided a mechanism for U.S. clinicians to administer CCP as an IND to hospitalized adult patients with moderate to severe COVID-19 disease. Without a control arm or centralized data collection on COVID patients who did not receive CCP, the analysis of EAP data was limited to comparison with previously published rates of COVID-19 mortality as well as transfusion-related adverse events. Reports indicated no unexpected increase in adverse events. 12 , 13 The EAP ended in late August 2020 with the announcement of EUA by the FDA for hospitalized patients with COVID-19.
Numerous blood donor centers in the US implemented SARS-CoV-2 IgG antibody testing of blood donors in spring/summer 2020 to assist in the recruitment and collection of CCP. 11 , 14 – 20 The FDA requires CCP to contain anti-SARS-CoV-2 antibodies; to ensure that the donors have sufficient antibodies, they must have had symptoms of COVID-19 and a positive test for COVID-19 or a reactive (positive) result in two different tests approved, cleared, or authorized by the FDA to detect SARS-CoV-2 antibodies. There is an additional recommendation to measure neutralizing antibody (nAb) titers if possible. 21 Published data report that 82%–93.5% of donors with prior SARS-CoV-2 infection have demonstrable IgG antibodies with a positive correlation detected between the level of SARS-CoV-2 IgG antibodies and nAb titers. 14 – 20 A time-dependent decline has been shown in both nAb titers and detectable IgG in CCP donors and the general population post-infection. This may impact the maximum time a recovered person may donate CCP and also has important implications for durability of immunity. 20
4.2 |. Retrospective STUDIES
Retrospective case–control studies with or without propensity matching have suggested potential efficacy for CCP. 22 , 23 Although these studies were limited by selection bias, some showed improved survival (adjusted hazard ratio in plasma recipients 0.13–0.89, p = .027). 22 Finally, a retrospective subgroup analysis of patients in the Mayo EAP showed a dose-dependent correlation between 30 days survival and anti-spike IgG antibody levels in administered CCP, but only among patients not receiving mechanical ventilation (relative risk 0.48–0.91 between high titer and low titer CCP recipients). 24
4.3 |. Randomized controlled trials
A limited number of randomized controlled trials (RCT) have been reported investigating the safety and efficacy of CCP in COVID-19 ( Table 2 ). 25 – 29 The only trial to date that has shown positive effect after CCP administration enrolled patients early in the course of disease, prior to hospitalization or moderate/severe respiratory compromise. 29 Conversely, no improvement in symptoms or survival benefit has been proven for CCP in hospitalized patients with moderate to severe COVID-19 prior to CCP administration. In the largest RCT to date, the RECOVERY trial in the United Kingdom found no mortality benefit to high-titer CCP versus usual care, both in the full study population and in the subgroup of those not receiving invasive mechanical ventilation at randomization. 28
Select randomized controlled trials of COVID-19 convalescent plasma
Antibody titer threshold | Conclusion | |
---|---|---|
Adults hospitalized with severe COVID-19 pneumonia | ||
Li et al. | 1:640 or greater anti-RBD | No effect on clinical improvement within 28 days |
Simonovich et al. | >1:400 anti-spike | No effect on 30 day mortality |
Agarwal et al. | None | No effect on progression or mortality at 28 days |
RECOVERY group | ≥1:100 neutralizing | No effect on 28 day mortality |
Adults with early COVID-19 disease | ||
Libster et al. | >1:1000 anti-spike | 0.20–0.81 relative risk reduction for severe respiratory disease |
Abbreviations: ELISA, enzyme-linked immunosorbed assay; RBD, receptor binding domain.
One significant limitation of these trials is lack of standardization for evaluation of anti-SARS-CoV-2 antibody potency. Most studies used binding anti-spike protein antibody assays, which are correlated, to a degree, with nAb titer. However, due to lack of standardized calibrators, comparing titer results from one assay to another is problematic.
4.4 |. Known and potential risks of CCP
The correlation between high burden of disease with COVID-19 and high titer binding anti-spike antibodies raises the question of whether antibody-dependent enhancement (ADE) may play a role in disease progression in a subset of patients. 30 Similarly, it is unclear if a subset of CCP donors may induce ADE in a subset of recipients. Furthermore, anti-interferon-1 autoantibodies have been associated with severe COVID-19 disease and it remains unclear whether transfused anti-INF-1 autoantibodies (or others) within CCP represent a risk to recipients. 31
5 |. ADULT TRANSFUSION PRACTICE
- The TRIST trial evaluated a restrictive (7 g/dl) versus liberal (9 g/dl) red blood cell (RBC) transfusion strategy for hematopoietic stem cell transplant (HSCT) patients. The restrictive strategy was noninferior based on the primary outcome, health-related quality of life (HRQOL) at day 100, supporting a restrictive approach to transfusion in this population.
- The Haemorrhage Alleviation with Tranexamic Acid-Intestinal System (HALT-IT) trial was an international, randomized, placebo-controlled trial evaluating the efficacy of tranexamic acid (TXA) in patients with gastrointestinal (GI) bleeding. The primary endpoint, death from bleeding within 5 days of randomization, was not different between the TXA and placebo groups. However, thromboembolic events were greater in the TXA group, suggesting that TXA should not be routinely used to treat GI bleeding outside of a clinical trial.
5.1 |. Trist trial
The Liberal Versus Restrictive Red Cell Transfusion Thresholds in Hematopoietic Cell Transplantation (TRIST) RCT evaluated a restrictive transfusion approach in a multicenter, chronic transfusion-dependent patient population. 32 Investigators used a non-inferiority design and randomized 300 HSCT patients to receive RBC transfusion for hemoglobin levels below either 9 or 7 g/dl. TRIST used HRQOL at day 100 measured by the Functional Assessment of Cancer Therapy—Bone Marrow Transplantation (FACT-BMT) instrument. The restrictive transfusion strategy was noninferior to the liberal strategy with respect to patients' FACT-BMT scores at day 100. The restrictive group also received fewer RBC transfusions (mean 2.73 vs. 5.02). There was no difference in other secondary outcomes, including transplant-related mortality and bleeding.
Most of the large RCTs evaluating RBC transfusion thresholds include mortality as the primary outcome. This crude outcome measure, while important, requires a large sample size because death is infrequent over a short follow-up period and transfusion is one of many interventions and aspects of patient care in this complex patient population. The TRIST trial's sample size of 300 is smaller than many of the well-known RBC transfusion threshold trials, since detecting a clinically significant change in HRQOL in response to transfusion did not necessitate such a large sample size. Importantly, however, by using HRQOL as the primary outcome, TRIST has begun to address a critical question about the effect of transfusion on patient-centered outcomes. The study design involved two-unit transfusions rather than the single-unit transfusion approach that is now standard for hemodynamically stable inpatients. Despite this limitation, the TRIST trial provides much needed evidence in a key patient population and ultimately does not support the need for a liberal transfusion strategy.
5.2 |. Halt-It trial
Antifibrinolytic agents, such as TXA, are commonly used to reduce bleeding in the setting of trauma, cardiac surgery, orthopedic surgery, and obstetric hemorrhage. Additionally, several small clinical trials have shown TXA reduces mortality in patients with upper GI bleeding, but were too small to assess the impact of TXA on thromboembolic adverse events. The HALT-IT trial was a large international RCT evaluating the effect of TXA on patients with GI bleeding. 33 Investigators enrolled over 12,000 patients in 15 different countries to receive TXA or placebo. The primary outcome was death from bleeding within 5 days of randomization, which was not different between the control or intervention groups (risk ratio 0.99, 95% confidence interval [CI] 0.82–1.18). Importantly, the TXA group had a higher rate of thromboembolic events compared with the placebo group. Overall, the findings from this study support the author's conclusion that TXA should not be used for treatment of GI bleeding outside of an RCT.
It is worth noting that the primary outcome of HALT-IT was changed during the trial from all-cause mortality to death due to bleeding within 5 days. The authors stated the change was due to a greater proportion of deaths occurring due to reasons other than bleeding than expected and because it was realized that TXA would not be expected to prevent re-bleeding after several days based on its short two-hour half-life.
6 |. WHOLE BLOOD FOR TRAUMA RESUSCITATION
- Low-titer group O whole blood (LTOWB) was adopted by more institutions, and studies continued to support its safety, with no detectable signal of deleterious effects.
- Multiple prospective and retrospective observational studies suggested that LTOWB may decrease mortality compared with component therapy in adult and pediatric trauma patients and those receiving massive transfusion; most studies were small and will require confirmation in RCTs.
There has been resurgence in the use of whole blood (WB) for trauma and massive transfusions. Advocates state that compared with component therapy, WB contains less anticoagulant, has less dilution of coagulation factors, and is logistically easier to manage. 34 Opponents have been concerned that even with LTOWB, ABO isohemagglutinins could have adverse effects on non-group-O recipients, and that platelets could be lost or become dysfunctional during leukoreduction or storage. 34 Over time, proponents of WB have countered these arguments by developing platelet-sparing leukoreduction filters, 34 showing equivalent safety of WB compared with components, 35 , 36 and with emerging evidence regarding its efficacy. Overall, WB continues to be validated as safe for adult and pediatric trauma. Recent observational data provides a rationale for current limited use with a trend toward superior outcomes.
6.1 |. Safety data
Harrold et al retrospectively examined 77 trauma patients (23 group O, 54 non-group O) at two hospitals who received at least 4 units of LTOWB. 37 Laboratory markers of hemolysis were measured, and there were no statistically significant differences between the group O and non-group O recipients.
The authors cautioned that right-censoring from patients who died within 24 h of transfusion and were excluded could have biased the results. They used ABO antibody titer cutoff of 50, but noted that it would be interesting to see similar data from hospitals that use higher titers for their cutoff and allow unlimited numbers of units of LTOWB for non-group O recipients.
6.2 |. Efficacy in adult civilian trauma
Retrospective and prospective observational studies in 2019–2020 have sought to associate WB use with improved outcomes in trauma patients when compared with component therapy. Data drawn from the Trauma Quality Improvement Database showed that trauma patients receiving WB had significantly decreased 24-hour and in-hospital mortality in both unadjusted and adjusted analyses. 38 In another study of 350 patients receiving prehospital or emergency department transfusions, 198 patients received WB and had significantly decreased risk of adjusted 30-day mortality. 39 A third study of 44 patients receiving WB in a massive transfusion setting showed a decrease in adjusted mortality at 24 hours and 28 days. 40
These three studies are limited by the nature of retrospective or observational design. While all three attempted some degree of adjustment for physiology, low incidence of the outcome of interest limits the generalizability of their adjusted models. Nevertheless, it is compelling that all three studies point in the same direction toward a probable benefit for WB in trauma.
6.3 |. Efficacy in pediatric trauma
Leeper et al. performed a propensity-matched analysis of injured pediatric patients who received component therapy (2013–2016, n = 28) versus LTOWB (2016–2019, n = 28). 41 The groups demonstrated no differences in in-hospital mortality, functional disability, hospital length-of-stay, or intensive care unit length-of-stay. However, the WB group had faster time to resolution of base deficit, lower post-transfusion INR, and lower amounts of RBCs, plasma, and platelets administered after adjusting for body weight.
No mortality benefit was seen in this study, which could be due to the fact that traumatic brain injury rather than hemorrhage was the predominant cause of death, and the relatively small amounts of WB used (median 15 ml/kg) could have been insufficient to yield significant benefit.
7 |. MOLECULAR IMMUNOHEMATOLOGY
- An array-based test for determining RBC, HLA, and HPA antigens was developed and validated using DNA samples from 7477 European blood donors and demonstrated 99.82% concordance with antigen types using other established methods.
- The genetic bases of several blood group systems were established: CTL2, PEL, and MAM. These systems were provisionally assigned the designations of IBST 039–041.
7.1 |. Large-scale genotyping
RBC genotyping is possible by various test platforms, 42 , 43 and mass genotyping of patients and donors holds the potential for multiple improvements in clinical TM. 44 However, for genotyping platforms to be universally adopted, a test has to be comprehensive, scalable, cost-effective, and paired with a software that can provide automated interpretation.
An international Blood Transfusion Genomics Consortium employed an array-based technology to develop and validate an inexpensive and nearly comprehensive genotyping approach. The UK BioBank version 2 Axiom Array (UKBBv2 array) tests genetic variants known to predict most RBC antigens, human platelet antigens (HPA), and human leukocyte antigens (HLA), reportedly at a cost of about $40 per sample. 45 They tested DNA samples from 7477 blood donors in England and the Netherlands, and analyzed the data using versions of the published bloodTyper algorithm 46 , 47 and freely available Applied Biosystems HLA Analysis tool. Array-based typing was then compared with the known “clinical” antigen types, which were established by both serological and DNA-based testing methods. The investigators found an overall 99.82% concordance in 103,326 comparisons across 28 RBC antigens, 10 HPA, and 6 HLA loci. Among the RBC antigen types, only 72 of 89,371 comparisons (0.08%) were discordant, and 33 of those (46%) were ultimately explained by erroneous serologic typing. The authors also attribute six discrepancies to newly identified alleles that they predict alter the expression of the antigens. Additionally, a total of seven ABO-related discrepancies were noted. Given the clinical significance of ABO-misinterpretation, the authors recommend typing for ABO using antibody-based methods.
To examine the clinical impact of the array-based genotyping, investigators retrospectively evaluated 3146 complex immunohematology cases (at least 3 RBC alloantibodies) and searched their pool of array-typed donors for matches. Compared with clinical typing alone, array-based typing yielded a 2.6-fold greater probability of identifying compatible donors. The benefit was greater for patients with rare combinations of antibodies, whereas for common antibody profiles, array-typed and clinically typed approaches were equivalent.
7.2 |. New blood group systems
For a blood group antigen to be designated as a new blood group system, International Society of Blood Transfusion (ISBT) requires that the gene encoding the antigen must be identified and sequenced. In 2019, Omae et al. showed that mutations in prion protein (PrP, CD230) are responsible for the KANNO-negative phenotype. 48 Stenfelt et al. and Veldhuisen et al. identified mutations on B4GALNT2-encoded galactosyl transferase as the genetic basis of the Sd(a)-negative phenotype. 49 , 50 ISBT thus assigned KANNO and SID as ISBT 037 and ISBT 038 blood group systems, respectively.
In 2020, the genetic basis of three additional blood group systems was discovered. Vrignaud et al performed whole exome sequencing on seven serologically compatible individuals to identify mutations in SLC44A2 gene. 51 Individuals from Moroccan ethnicity had a missense mutation in exon 14 of the gene, while the proband of European ancestry exhibited a large deletion of the gene. Using flow cytometric and western blot analysis, authors demonstrated that the antibody reactivity in the probands was targeted against the SLC44A2 (also known as CTL2) protein. The SLC44A2/CTL2 protein is highly expressed on human neutrophils and bears the human neutrophil antigen 3. ISBT has provisionally assigned the designation of ISBT 039 to the CTL2 blood group system.
Azouzi et al. established the genetic basis for the PEL-negative phenotype. 52 Using a combination of whole exome sequencing on four unrelated PEL-negative French-Canadian individuals, and a comparative proteomics approach to analyze the differential expression of proteins in RBC membranes from three PEL-negative and three PEL-positive individuals, the authors identified a large deletion of the ABCC4/MRP4 gene as the basis of the PEL-negative phenotype. Using flow-cytometry, CRISPR-Cas9 technology, western blotting, and immunoprecipitation, they demonstrated that mutations in ABCC4 are responsible for the absence of PEL antigen, and the specificity of the alloantibody seen in the PEL-negative individuals is directed against the ABCC4 protein. The PEL-negative individuals demonstrated impaired platelet aggregation in vitro; however, none showed easy bruising or increased bleeding. PEL blood group has provisionally been assigned ISBT 040 designation.
Thornton et al described the molecular basis of the high-prevalence MAM antigen. 53 Anti-MAM has been shown to cause severe hemolytic disease of the fetus and newborn. Whole exome sequencing on 10 MAM-negative individuals identified a variety of inactivating mutations in the EMP3 gene, ranging from whole gene deletion to single exon deletion and nonsense mutation. A combination of approaches including short hairpin RNA, CRISPR-Cas9, and transfected cells demonstrated that the expression of MAM antigen is dependent upon intact EMP3 gene. MAM blood group has provisionally been assigned ISBT 041 designation.
8 |. PEDIATRIC & NEONATAL TRANSFUSION
- The age of RBC products transfused in pediatric intensive care patients did not impact the incidence of new or progressive multiple organ dysfunction syndrome.
- Liberal blood transfusions compared with restrictive RBC transfusions in extremely low-birth-weight infants did not reduce the likelihood of death or disability at 24 months of corrected age.
- A prophylactic platelet transfusion threshold of 25 × 10 9 /Ldid not increase the likelihood of bleeding in preterm neonates over that of 50 × 10 9 /L.
8.1 |. RBC trials
The Age of Blood in Children in Pediatric Intensive Care Unit Trial published by Spinella et al. 54 found that the age of RBCs did not impact the incidence of new or progressive multiple organ dysfunction syndrome including mortality in critically ill children (3 days–16 years). Subjects were followed for up to 28 days or until discharge or death, whichever came first. The primary objective of the trial was to determine whether fresh (≤7 days old) RBCs were superior to standard issue RBCs, and no significant differences were found in 1538 randomized patients. Seven-hundred and twenty-eight subjects who received fresh and 733 who received standard issue RBCs were included in the primary analysis. The median storage duration of RBCs was 5 days (IQR, 4–6 days) in the fresh and 18 days (IQR, 12–25 days) in the standard issue group ( p < .001). New or progressive multiple organ dysfunction was found in 20.2% of the fresh versus 18.2% of the standard issue groups (unadjusted absolute risk difference 2%, 95% CI, 2.0% to 6.1%, p = .33). The prevalence of acute respiratory distress-syndrome was 6.6% in the fresh versus 4.8% of the standard issue group. Intensive care unit mortality was 4.5% in the fresh versus 3.5% in the standard issue group ( p = .34).
The Effects of Transfusion Thresholds on Neurocognitive Outcomes of Extremely Low Birth-Weight Infants Trial published by Franz et al., 55 demonstrated no statistical difference between outcomes based on receiving liberal or restrictive RBC transfusion therapy in extremely low-birth-weight infants (<1000 g at birth). The incidence of transfusion was 81.3% in the liberal versus 60.5% in the restrictive group. The RBC transfusion threshold varied by the weight of the patient. The median volume transfused was 40 ml versus 19 ml. The mean weekly hematocrit was 3% points higher with the liberal threshold. The primary outcome, defined as death or neurodevelopmental impairment by 24 (+/−1) months of corrected age, was not statistically different between the groups ( p = .72), nor were the secondary outcomes of death, cognitive deficit, or cerebral palsy. No differences were observed between those that developed necrotizing enterocolitis requiring surgical intervention, bronchopulmonary dysplasia, or treatment for retinopathy of prematurity. Liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age.
8.2 |. Platelet trial
The Platelets for Neonatal Thrombocytopenia trial previously reported a 7% absolute-risk reduction using a prophylactic transfusion threshold of 25 × 10 9 /L compared with 50 × 10 9 /L for major bleeding and/or mortality in preterm neonates. 56 Fustolo-Gunnink et al. 57 assessed whether the findings were heterogeneous across different subpopulations. Neonates were categorized into 4 risk quartiles based on their baseline risk of major bleeding and/or death ( N = 653). A total of 146 neonates died or developed major bleeding. The 25 × 10 9 /L threshold was associated with an absolute-risk reduction in all risk groups varying from 4.9% in the lowest risk group (those predicted least likely to experience major bleeding and/or death) to 12.3% in the highest risk group. The authors concluded that the 25 × 10 9 /L transfusion threshold should be adopted for all neonates.
9 |. CELLULAR THERAPY
- Allogeneic chimeric antigen receptor (CAR)-NK-cells were successfully used to treat CD19-positive lymphoid tumors without significant toxicity.
- Anti-CD19 CAR-T cells were successful in treating mantle cell lymphoma resistant to Bruton Tyrosine Kinase (BTK) inhibitors.
9.1 |. CAR-NATURAL killer (NK) cells in CD19-POSITIVE lymphoid tumors
Autologous derived T-cells engineered to target CD19-positive cells have emerged as a promising new treatment option for patients with B-cell malignancies. This has led to the FDA approval of two CAR T-cell products . 58 , 59 CAR T-cell therapy, however, has numerous limitations. Typically, it requires a patient with relapsed or refractory disease to forego lymphodepleting chemotherapy for a period in order to undergo autologous collection of mononuclear cells, which then require complex and time-consuming manufacturing.
Liu et al performed a phase-1/2 clinical trial to test the safety and efficacy of engineered NK cells that were derived from an allogeneic source. 60 NK cells from cord blood were transduced with a vector expressing genes that code for anti-CD19 CAR, interleukin-15 to enhance in vivo expansion and persistence, and an inducible caspase 9 to be deployed as a safety switch. Of the 11 patients with relapsed or refractory B-cell malignancies (CLL and non-Hodgkin's lymphoma) who were infused with ex vivo expanded anti-CD19 CAR NK-cells, 8 (73%) patients showed a rapid clinical response with 7 (64%) patients exhibiting a complete remission. No significant toxicities attributable to NK cells were noted in these patients. Durability of response after CAR NK-cell therapy could not be assessed, as the patients underwent post-remission treatment at the discretion of treating physicians.
While patients in this trial received freshly manufactured CAR NK-cells, the successful use of allogenic derived NK cells creates the possibility of these cellular therapy products being stored and readily administered to a patient in need.
9.2 |. CAR-T cells in mantle cell lymphoma
Patients with mantle cell lymphoma resistant to BTK inhibitors have a very poor prognosis. The ZUMA-2 clinical trial was a multicenter, single-arm, phase 2 trial evaluating the safety and efficacy of KTE-X19 in adult patients with refractory or relapsed mantle cell lymphoma who were previously treated with BTK inhibitors. 61 KTE-X19 is an autologous derived in vitro expanded anti-CD19 CAR T-cell therapy. Of the 74 patients enrolled, 68 received KTE-X19 CAR T-cell therapy. Analysis of primary efficacy in 60 patients demonstrated that 93% had an objective response and 67% exhibited complete remission. In an intention-to-treat analysis of all enrolled patients, 85% demonstrated objective response and 59% entered remission. At 12 months, the progression-free and overall survival rates were 61% and 83%, respectively. The authors did report serious adverse events, including grade 3 or higher cytokine release syndrome and neurologic events in 15% and 31% of the patients, respectively. Other serious side effects included cytopenias and infections.
While the trial showed that the majority of patients with relapsed or refractory disease demonstrated a clinical response and went into remission, serious adverse events like those reported with use of CAR T-cell therapies were also noted. The FDA approved KTE-X19 in July 2020. 62
10 |. THERAPEUTIC APHERESIS
- The study examining plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (PEXIVAS) demonstrated that plasma exchange did not reduce the incidence of death or end-stage kidney disease (ESKD) among patients with severe disease. This prompted the Journal of Clinical Apheresis ( JCA ) Special Issue Writing Committee to release an updated fact sheet changing the category recommendation from I to II.
- A multicenter, double-blind, randomized, placebo-controlled trial of Alzheimer's disease management by plasma exchange with albumin replacement and intravenous immunoglobulin dosing (AMBAR) demonstrated that plasma exchange could slow cognitive and functional decline in mild-to-moderate Alzheimer's disease.
10.1 |. PEXIVAS study
The results of the Plasma Exchange and Glucocorticoid Dosing in the Treatment of ANCA-Associated Vasculitis (PEXIVAS) study were recently published. 63 This international RCT enrolled 704 patients with ages 15 years or older from 95 centers in 16 countries. It is the largest study published to date on the role of therapeutic plasma exchange (TPE) in ANCA-associated vasculitis (AAV). The 2 × 2 factorial study design compared TPE versus no TPE and standard versus reduced-dose steroid regimen on the primary composite outcome of ESKD or death in patients with AAV. The study concluded that TPE did not reduce the incidence of ESKD or death and that a reduced-dose regimen of glucocorticoids was non-inferior to a standard dose regimen. The study included 191 patients with pulmonary hemorrhage (61 severe) and did not observe a beneficial treatment effect in this subset of patients.
There are at least two important limitations of this study that may influence the interpretation of the results. 64 First, kidney biopsy was not required for trial participation. In a chronic disease that leads to irreversible kidney scaring, the effect of TPE on the subset of patients with acute disease that may be more responsive to possible short-term improvement in kidney function, as shown in the MEPEX study, 65 remains unknown. Second, the trial was not designed to assess the role of TPE in patients with pulmonary hemorrhage and may have been underpowered to detect a difference in this subset of patients. 66 – 68
Based on the results of this study, the JCA Special Issue Writing Committee released an updated fact sheet in August 2020 incorporating this newly available evidence. 69 The category recommendation for rapidly progressive glomerulonephritis (RPGN) and Cr ≥5.7 mg/dl in the setting of microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), or renal-limited vasculitis (RLV) was changed from category I to II to support use of TPE in select patients with biopsy-proven acute RPGN. Diffuse alveolar hemorrhage (DAH) in the setting of AAV remained a category I indication for TPE due to the life-threatening nature of this complication and the lack of alternative treatments.
10.2 |. AMBAR study
The results of the Alzheimer's Management By Albumin Replacement (AMBAR) study were recently published. 70 This phase 2b/3, double-blind trial randomized 347 Alzheimer's disease (AD) patients from 41 sites in the United States (22) and Spain (19). Subjects between 55 and 85 years of age with a probable diagnosis of mild-to-moderate AD (Mini-Mental State Examination [MMSE] score of 18–26) and receiving stable doses of acetylcholinesterase inhibitors and/or N-methyl-D-aspartate receptor antagonists were assigned to one of three TPE treatment groups with varying doses of albumin and intravenous immune globulin (IVIG) or a placebo group that included sham TPE. The primary endpoint assessed changes from baseline to 14 months in two measures: the AD Cooperative Study-Activities of Daily Living (ADCS-ADL) and the AD Assessment Scale-Cognitive Subscale (ADAS-Cog). The study concluded that the TPE-treated patients had significantly less decline compared with placebo (ADCS-ADL, 52% less decline, p = .03; ADAS-Cog, 66% less decline, p = .06). In subgroup analysis, there were no significant differences between the three TPE treatment groups, nor between those subjects with mild AD (MMSE 22–26) versus the placebo group. While these results are encouraging, future studies should further investigate the mechanism by which AD progression was slowed, the necessity of IVIG, the impacts of various demographic and AD parameters on treatment response, and the durability of treatment response after cessation of therapy. 71
ACKNOWLEDGMENTS
We acknowledge Margaret A. Keller, PhD, of the American Red Cross National Molecular Laboratory for input regarding manuscript selection.
Abbreviations:
AAV | ANCA-associated vasculitis |
AD | Alzheimer's disease |
ADE | antibody dependent enhancement |
ANCA | anti-neutrophil cytoplasmic antibody |
BTK | bruton's tyrosine kinase |
CAR | chimeric antigen receptor |
CCP | COVID convalescent plasma |
CTMC | clinical transfusion medicine committee |
DAH | diffuse alveolar hemorrhage |
EAP | expanded access protocol |
ESKD | end-stage kidney disease |
EUA | emergency use authorization |
FDA | food & drug administration |
GI | gastrointestinal |
GPA | granulomatosis with polyangiitis |
HLA | human leukocyte antigens |
HPA | human platelet antigens |
HRQL | health related quality of life |
HSCT | hematopoietic stem cell transplant |
IND | investigational new drug |
INR | international normalized ratio |
ISBT | international society of blood transfusion |
IVIG | intravenous immunoglobulin |
LTOWB | low-titer group O whole blood |
MMSE | mini-mental state examination |
NK | natural killer |
RCT | randomized controlled trial |
RLV | renal-limited vasculitis |
RPGN | rapidly progressive glomerulonephritis |
TM | transfusion medicine |
TPE | therapeutic plasma exchange |
TQIP | trauma quality improvement database |
TXA | tranexamic acid |
CONFLICT OF INTEREST
CSC has disclosed professional relationships with Grifols, Terumo BCT, and Instrumentation Laboratory. NMD has disclosed financial relationship with Verax Biomedical. TG has disclosed professional relationship with Fresenius Kabi. JSR has disclosed financial relationships with Terumo BCT and Sanofi Genzyme. ESA, SB, CKH, JJ, PML, RAM, CM, MTP, HS, EKS, and MBP have disclosed no conflicts of interest.
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Immunohematology and Blood banking
Principles and Practice
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- Pritam Singh Ajmani 0
Ruxmaniben Deepchand Gardi Medical College, Surasa, India
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Transfusion Medicine
Red Blood Cell Transfusion
Modern Blood Banking
- Blood Group
Table of contents (15 chapters)
Front matter, introduction.
Pritam Singh Ajmani
Blood Group and Immunology
Donor blood collection, storage of blood, transfusion of blood & its components, blood component preparation, blood test in immunohematology and blood banking, hemolytic disease of the newborn, history of blood transfusion, massive blood transfusion, autologous blood transfusion, blood management, blood bank protocols, blood bank inventory, transfusion reactions, back matter, authors and affiliations, about the author, bibliographic information.
Book Title : Immunohematology and Blood banking
Book Subtitle : Principles and Practice
Authors : Pritam Singh Ajmani
DOI : https://doi.org/10.1007/978-981-15-8435-0
Publisher : Springer Singapore
eBook Packages : Medicine , Medicine (R0)
Copyright Information : The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2020
Hardcover ISBN : 978-981-15-8434-3 Published: 03 November 2020
Softcover ISBN : 978-981-15-8437-4 Published: 04 November 2021
eBook ISBN : 978-981-15-8435-0 Published: 02 November 2020
Edition Number : 1
Number of Pages : XXIII, 208
Number of Illustrations : 2 b/w illustrations, 6 illustrations in colour
Topics : Pathology
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Basic and Applied Concepts of Blood Banking and Transfusion Practices (3 rd Edn.)
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Roslyn Yomtovian, Basic and Applied Concepts of Blood Banking and Transfusion Practices (3 rd Edn.), Laboratory Medicine , Volume 44, Issue 2, May 2013, Pages e35–e36, https://doi.org/10.1309/LM675IDGQXQRELIF
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Basic and Applied Concepts of Blood Banking and Transfusion Practices is intended for those who require detailed knowledge and an understanding of immunohematology to perform their jobs—namely, medical technologists and technicians working in a blood bank or transfusion-medicine laboratory. The text begins on a strong note with the first chapter, “Immunology: Basic Principles and Applications in the Blood Bank,” which provides an excellent overview of the basic concepts of immunohematology, including the reactivity of antibodies and antigens. One of the characteristics of this text is its ability to be comprehensive yet concise and clear. The text emphasizes the importance of understanding historical terminology while presenting the most up-to-date immunohematology techniques. This is particularly true for the section on Rh, which combines just enough history of the nomenclature while covering the many aspects needed to delineate today’s methodology. The text is organized to provide detailed didactic information, beginning with a chapter outline and followed by learning objectives. Also, essential terms are defined in the margins near their use in the text. Further, each chapter is reinforced with a chapter summary, critical-thinking exercises, and study questions with answers. Each section is replete with tables and figures to further reiterate and illustrate important concepts. A comprehensive glossary is also provided. Although the book is well-stocked with references, many of the references are older and could have been updated to correspond with the 2013 edition of the text.
Nearly all of the technical sections are well written and clear; the section on the ABO, H, and Se blood groups is particularly articulate, practical, and concise. This should make the understanding of the typically difficult topic of blood banking and transfusion accessible to most students of medical technology.
I recommend this text to medical technology students and technologists; however, the text has certain shortcomings. This is particularly evident in the chapter on adverse complications of transfusions. Unlike the previous chapters, which deal with technical issues, this chapter focuses on clinical issues and tries to convey too much information in a short span of pages.
Also, there are notable contradictions in the text. For example, when the text describes blood-group antibodies associated with delayed hemolytic reactions, it mentions, in decreasing order of frequency, antibodies in the Kidd, Duffy, Kell, and MNS systems. Actually, the most common antibodies are those in the Rh system, particularly anti-C and anti-E. Another example is that the text notes that there are no major complications for delayed hemolytic transfusion reactions compared with acute reactions. I argue that the development of severe anemia associated with a delayed reaction could be a clinically significant event. In contrast, regarding an even more minor reaction, the text notes that febrile nonhemolytic transfusion reactions are usually not life-threatening for the recipient—by definition, this type of reaction should never be life-threatening for the recipient because other significant causes of fever have been excluded. Another problem is inconsistent information between the text and tables. For example, under the heading of Transfusion-Related Acute Lung Injury, the text notes this injury as occurring 1 to 2 hours after transfusion. The table immediately adjacent to this portion of the text notes a 6-hour window of occurrence (this is the correct time interval). Several other examples can be cited in the text, such as the statement that transfusion should be completed in 4 to 6 hours—it should take 4 hours—and attribution of instances of platelet bacterial contamination to improper cleansing of the donor’s skin during blood collection. The latter may rarely occur; however, in most cases, proper skin cleansing has been accomplished despite instances of platelet bacterial contamination.
Thus, for those using this text as an instructional manual, I recommend that the chapter “Adverse Complications of Transfusions” be replaced with more accurate clinical material. Despite this, the technical chapters of this text contain much useful information for the teaching and training of technologists and technicians in blood-bank operations.
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Current advances in transfusion medicine: a 2019 review of selected topics from the AABB Clinical Transfusion Medicine Committee
Affiliations.
- 1 Transfusion Medicine Division, Department of Laboratory Medicine, University of Washington, Seattle, Washington.
- 2 Department of Pathology, University of California San Diego, La Jolla, California.
- 3 Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
- 4 Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
- 5 NorthShore University Health System, Chicago, Illinois.
- 6 Transfusion Medicine Division, Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, Maryland.
- 7 Division of Hematology/Oncology, Simmons Cancer Institute at Southern Illinois University School of Medicine and Mississippi Valley Regional Blood Center, Springfield, Illinois, USA.
- 8 Pathology and Laboratory Medicine, University of Vermont Medical Center, Burlington, Vermont.
- 9 Vitalant, Scottsdale, Arizona.
- 10 Department of Pathology, New York University Grossman School of Medicine, New York, New York.
- 11 Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
- 12 Clinical Pathology Division, Department of Pathology, University of Utah, Salt Lake City, Utah.
- 13 Transfusion Medicine Service, Department of Pathology, University of New Mexico, Albuquerque, New Mexico.
- 14 Transfusion Medicine & Cellular Therapy, Department of Pathology & Cell Biology, Columbia University, New York, New York.
- 15 Department of Pathology, Stanford University, Stanford, California.
- 16 Division of Pediatric Critical Care, Washington University in St Louis, St Louis, Missouri, USA.
- 17 Office of Blood Research and Review, Food and Drug Administration, Silver Spring, Maryland.
- 18 Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.
- PMID: 32472580
- DOI: 10.1111/trf.15848
Background: The AABB Clinical Transfusion Medicine Committee (CTMC) compiles an annual synopsis of the published literature covering important developments in the field of transfusion medicine (TM) for the board of director's review. This synopsis is now made available as a manuscript published in TRANSFUSION.
Study design and methods: CTMC committee members review original manuscripts including TM-related topics published in different journals between late 2018 and 2019. The selection of topics and manuscripts are discussed at committee meetings and are chosen based on relevance and originality. After the topics and manuscripts are selected, committee members work in pairs to create a synopsis of the topics, which is then reviewed by two committee members. The first and senior authors of this manuscript assembled the final manuscript. Although this synopsis is comprehensive, it is not exhaustive, and some papers may have been excluded or missed.
Results: The following topics are included: infectious risks to the blood supply, iron donor studies, pre-transfusion testing interference and genotyping, cold agglutinin disease (CAD), HLA alloimmunization in platelet transfusions, patient blood management, updates to TACO and TRALI definitions, pediatric TM, and advances in apheresis medicine.
Conclusion: This synopsis provides easy access to relevant topics and may be useful as an educational tool.
© 2020 AABB.
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On Medicine
Topics in blood transfusion
Today marks World Blood Donor Day and so we asked Deputy Editor for Journal of Intensive Care , Hiroshi Morisaki, to explain more about the importance of blood transfusion, and how research in this area is progressing.
Hiroshi Morisaki 14 Jun 2016
To date, humans have uncovered a number of natural principles and issues such as the origin and mysteries of the universe, the earth and even life. We have simultaneously developed innumerable non-natural products for human use.
However, we have not yet succeeded in creating a man-made, cost-effective alternative to red blood cells (RBCs) despite the performance of extensive research and numerous clinical trials.
A life-saving intervention
The cellular health of the host requires an oxygen (O 2 ) supply that matches the O 2 requirements of its tissue. An insufficient O 2 supply results in ischemia, subsequently inducing tissue and/or organ injury, frequently observed in critically ill patients.
RBC transfusion, first performed over 300 years ago, remains a fundamental life-saving intervention in medicine.
Hemoglobin, which is enclosed in RBCs as an O 2 carrier, plays the most important role in supplying O 2 to the tissues. Accordingly, RBC transfusion, first performed over 300 years ago, remains a fundamental life-saving intervention in medicine.
Until the early 1980s, RBC transfusion was considered to be practically risk-free and a truly effective intervention in patients with active bleeding or anemia due to a variety of reasons in the intensive care field.
However, the threat of potentially-fatal transfusion-related infections, i.e., human immunodeficiency virus, has led physicians throughout the world to obviate this conventional intervention to the extent that is possible.
Research in the literature
In 1999, Canadian investigators examined the effects of a restrictive RBC transfusion strategy in comparison to a liberal strategy in critically ill patients. They indicated that a restrictive strategy was at least as effective as and possibly superior to a liberal transfusion strategy in critically ill patients with some exceptions.
Although several debates are currently ongoing, most physicians now agree that a restrictive strategy to limit RBC transfusion is a valuable approach in the treatment of stable patients with anemia.
However, we need to be cautious when interpreting the results of the Canadian study as it indicated some exceptions.
Even though we have seen extraordinary advances in medical science and related technology over the last several decades, clinical practices have been determined based on the balance between the benefits and related risks of intervention.
They found that a restrictive transfusion strategy was significantly associated with reduced mortality in younger patients and in those with less severe conditions. In other words, a liberal RBC transfusion strategy might be more effective for older patients and patients with more severe conditions.
RBC transfusion by itself is not an exception. The level of hemoglobin that works in some patients may not work in others. Indeed, a previous cohort study of intensive care unit patients suggests that restrictive RBC transfusion policies may not be uniformly applicable in the clinical setting.
World Blood Donor Day
In 2012, the World Health Organization (WHO) released a document entitled, “ Blood donor selection – Guideline on assessing donor suitability for blood donation ”. In this guideline, the authors noted that a careful process to assess the suitability of donors is essential for protecting the safety and sufficiency of the blood supply, and safeguarding the health of both ‘recipients’ and ‘donors’. We should therefore understand that blood transfusion not only improves the recipients’ conditions but also affects the donors’ health.
Away from the discussion of whether restrictive or liberal RBC transfusion strategies should be applied, natural human blood is needed to save the lives in emergency and long-term treatment settings, even in the 21 st century.
If you believe yourself to be in good health, you should donate your blood to prove it and to save lives at the same time.
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- Research note
- Open access
- Published: 06 November 2019
Blood donors’ knowledge and attitude towards blood donation at North Gondar district blood bank, Northwest Ethiopia: a cross-sectional study
- Bamlaku Enawgaw ORCID: orcid.org/0000-0002-3828-5318 1 na1 ,
- Aregawi Yalew 1 &
- Elias Shiferaw 1 na1
BMC Research Notes volume 12 , Article number: 729 ( 2019 ) Cite this article
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Blood transfusion saves millions of lives. But, the need and the actual number of donations are not balanced in Ethiopia. The actual reason is not clearly assessed; however, level of knowledge and attitude may be the main contributing factors. Thus, the current study aimed to assess blood donors’ knowledge and attitude towards blood donation at North Gondar district blood bank.
Of 401 blood donors, 142 (35.4%) and 379 (94.5%) were had adequate knowledge and positive attitude towards blood donation, respectively. About 343 (85.5%) of study participants had no previous experience of blood donation. Perceptions of fear of pain, medically unfitness to donate and lack of information on when, where and how to donate blood were mentioned as a reason for not donating blood. Educational status and residence were significantly associated with knowledge of blood donors. On the other hand, participants with secondary and higher education were more likely to have good attitude towards blood donation. Thus, blood banks should design strategies for health education about blood donation and transfusion.
Introduction
Blood donation is remained the major source of blood and blood components worldwide. Even though extensive promising research have come up, a true substitute for blood and blood components is not available [ 1 ]. Donated blood is an essential component in the management of many diseases. It is the main lifesaving for an individual with loss of large volumes of blood from accidents, hemorrhages or surgery [ 2 ].
The source for blood to be transfused relies mainly on voluntary non-remunerated blood donors [ 3 ]. Even though over a million of blood units are collected every year, many more millions still need to be collected to meet the global demand, ensure the sufficient and timely provision of blood [ 4 ]. However, the demand and supply are not being balanced; the demand is escalating. This is the reason why in Sub-Saharan Africa replacement and paid donors are common in contrary to voluntary and non-remunerated donors [ 5 ].
Evidences showed that the annual global blood collection is 112.5 million units of blood. Over half of these units of blood are collected in developed countries. The blood donation rate per 1000 people in high income countries is more than fivefold compered to low income countries (33.1 vs 4.6 donations). Voluntary blood donors cover over 90% of donations in developed countries while they account below 50% in developing countries [ 6 ].
Ethiopia is a country with high maternal mortality (676 per 100,000) and high motor accident and with a large nonimmune population for malaria [ 7 ]. There is insufficiency and in-equitability in access to blood. The average annual national requirement for blood in Ethiopia is 100,000 units per year, but only 43% is collected [ 8 ]. From WHO African countries, Ethiopia has the least number of voluntary blood donors (VBD) with 22% which is extremely very low [ 9 ].
The availability and safety of blood still remain inadequate to meet the increased demand of blood and blood components particularly in Sub-Saharan Africa like Ethiopia [ 5 , 10 ]. As a result, these countries try to compensate their blood demand from family replacement or paid donors. But in this type of donors, higher rates of transfusion-transmitted infections have been documented [ 6 ]. It is explained that healthy VBD donate their blood by their own free will without any pressure, whereas family replacement donors donate blood for fear of loos of their relatives without considering their health status [ 11 ].
The actual reason why large proportion of the potentially eligible population do not actively donate blood is not clearly assessed in Ethiopia. The blood donors’ attitude, beliefs, and knowledge may be a factor for not being a blood donor. Thus, the current study was aimed to assess blood donors’ knowledge and attitude towards blood donation at North Gondar blood bank district, Northwest Ethiopia. The findings will be used as a baseline information for the blood banks to plan an effective strategy to increase and maintain safe and adequate blood supply.
Study setting and population
A cross-sectional study was conducted on 401 blood donors at North Gondar blood bank district, Northwest Ethiopia. This blood bank is the only blood bank center located in Gondar for North Gondar, Amhara regional state, at 738 km far from Addis Ababa, capital city of Ethiopia. The blood bank gives serves for the surrounding hospitals in the district.
Sample size determination and sampling technique
To determine the required sample size for study, a single population proportion formula was used as denoted below.
where z α/2 = 1.96 at 95% confidence interval, p = 50% because there is no previous study, d = 5% which is tolerable error between the sample and true population.
Considering 5% non-response rate (384 × 5% = 19), the final sample size becomes 403. The study participants were selected randomly from the blood donors in the blood bank.
Data collection
The study participants were interviewed during blood donation after obtaining written informed consent. We used a structured pretested questionnaire to collect socio-demographic data, knowledge, attitude, previous blood donation history and reasons for not donating blood previously. In addition to pretest, training was given for data collectors about data collection procedures and objectives of the study. Consistency of the collected data was also checked daily.
Knowledge assessment towards blood donation
We used nine questions to assess knowledge of blood donors. For the “correct” and “incorrect” response, “1” and “zero” score were used, respectively. Then the total score was obtained by summing up of the nine knowledge questions score. The scoring ranges from 0 to 9. Those blood donors who answer “five” and more questions correctly from 9 (> 50%) were considered as knowledgeable.
Attitude assessment towards blood donation
In this study, attitude was assessed using eight questions. Similar to knowledge scoring “1” and “zero” were used for favorable and unfavorable attitude, respectively. The total score was calculated up to determine the total attitude score. The score was ranged from 0 to 8. Attitude score of half and more (50%) was considered as favorable attitude.
Data analysis and interpretation
Data were entered with Epi info 3.5.1 and transported to SPSS 20 for analysis. Descriptive results were summarized and presented with tables. The association of the independent variable with the categorical outcome variable was measured by calculating odds ratio with 95% confidence interval using bivariate and multivariate logistic regression. P value < 0.05 was considered as statistically significant.
Sociodemographic characteristics of study participants
In this study a total of 401 (259 male and 142 female) study participants was included. The response rate was 99.5% (401/403). The mean age of study participants was 26.2 ± 8.2 years ranging from 18 to 57 years old. The majority 212 (52.9%) of them was in the age group of 18–23 years. More than half 235 (58.6%) of the donors had been attending higher education. Majority 188 (46.9%) and 281 (70.1%) of the study participants were students and single in marital status, respectively (Table 1 ).
Knowledge of study participants
From the total study participants, 142 (35.4%) had adequate knowledge towards blood donation. The mean knowledge score of the participants was 4.03 ± 1.44. All of the study participants argued that the importance of blood donation is to save life. From the total study participants, 380 (94.8%) of them had information regarding screening of donated blood for infectious disease before transfusion. But only 20 (5.0%) of the study participants knew HIV, hepatitis virus and syphilis are considered as transfusion transmittable infections (Additional file 1 ).
Attitude of the study participants
Nearly all [379 (94.5%)] of the study participants had favorable attitude towards blood donation. The mean attitude score of the participants was 7.48 ± 1.23. Majority 365 (91.0%) of the participants had a plan to donate blood voluntarily in the future and about 360 (89.8%) of the study participants had plan to become a regular blood donor. Majority 373 (93%) of the study participants had a perception of donation is not harmful to donors (Additional file 1 ).
Previous practice of blood donation
Less than one quarter 58 (14.5%) of study participants had previous history of donation and more than half 229 (57.1%) of them were replacement type of donors. Several factors have been mentioned as a reason for not donating blood previously. About 139 (40.5%) of the blood donors mentioned lack of information (when, where and how to donate) as the main reason for not donating blood previously. Fear of pain, perceptions of unfitting to donate and consideration of donation as harmful practice had also been mentioned as a reason for not donating blood previously (Additional file 2 ).
Factor associated with knowledge of blood donors
In multivariate logistic regression analysis educational status, residence, previous donation history and donor type were significantly associated. Study participants who attained higher education (AOR = 2.8, 95% CI 1.35, 6) and those who lived in urban (AOR = 2.5, 95% CI 1.26, 4.81), history of previous donation (AOR = 2.2, 95%CI 1.13, 4.48) and being volunteer blood donors (AOR = 3.1, 95%CI 1.5, 6.56) were more likely to have adequate knowledge. Age, gender, marital status and occupation were not showed a statistically significant association (Table 2 ).
Factor associated with attitude of blood donors
Bivariate logistic regression analysis showed that age, educational status, occupation, residence and marital status were significantly associated with attitude of participants. While in multivariate logistic regression analysis none of them were statistically significant. Variables such as gender, previous donation history and donor type did not fulfil the criteria for logistic regression analysis and were excluded from analysis (Table 3 ).
In this study about one-third of blood donors had adequate knowledge towards blood donation. The result was slightly higher than a study conducted in Jordan which reported that 28.6% of them had adequate knowledge towards blood donation [ 4 ]. The possible reason for this discrepancy might type of blood donors. In our study, the number of replacement type of blood donors was relatively low (229 vs 348). It is strongly believed that volunteer blood donors are more likely to have good knowledge towards blood donation compared to replacement type donors and it is considered as major contributing factor for blood donation. This study showed that 61% of voluntary and 16.2% of replacement blood donors had adequate knowledge.
On the other hand, the level of knowledge in this study was lower than studies from Gondar [ 12 ], Bahir Dar [ 13 ], Wolita Sodo [ 14 , 15 ], Tigray [ 16 ], Birbir Town [ 17 ], Harar [ 18 ], Basrah, Iraq [ 19 ] and India [ 20 ]. The difference may be associated with the type of study subjects included in the studies. The above-mentioned studies include medical and health science students and also health care workers. Thus, it is expected that this group of people have high level of knowledge towards blood donation.
In the current study, all of the participants argued that the importance of blood donation is to save life. But a previous report from Gondar town showed a slight deviation result of 88.3% [ 21 ]. Similarly, it was higher than a study conducted in Democratic Republic of Congo which showed that only 183 (44.1%) of the study participants strongly advocates this idea [ 22 ]. The difference might be due to variation in study subjects (blood donors vs general population in the community).
In this study, participants who attained higher education and lived in urban were more likely to have adequate knowledge towards blood donation. This is supported by studies in Birbir Town [ 17 ] and Harar [ 18 ] in which individuals with higher education has high level of knowledge. Similarly, those donors who were donate blood previously and volunteer donors were had adequate knowledge compared to their counterparts. This is true that if someone had experience, he/she has high level of knowledge. Thus, it is not surprise that if the donors with previous history had adequate knowledge.
Regarding to attitude, nearly all of the respondents had a good attitude towards blood donation. The finding was slightly higher as compared to the previous report from Gondar [ 12 , 21 ], Bahir Dar [ 13 ], Wolita Sodo [ 14 , 15 ], Tigray [ 16 ], Birbir Town [ 17 ], Harar [ 18 ], Basrah, Iraq [ 19 ] and India [ 20 ]. The difference might be due to variation in study method and subjects since the current study was institutional based study conducted among the blood donors.
We tried to assess the association of blood donors’ characteristics with their attitude. Variables such as age, educational status, occupation, residence and marital status were assessed, but none of them showed statistically significant association. Nearly all (94.5%) of the study participants had favorable attitude towards blood donation.
In this study, attitude towards blood donation was high, but the level of knowledge was inadequate. Education, residence, previous blood donation and donor type were statistically associated with adequate knowledge. To increase the level of knowledge towards blood donation, health education to the community is recommended.
Limitations
The findings in this study are from one district and only interview-based data were collected. There was no focus group discussion for further analysis of the knowledge and attitude of the participants.
Availability of data and materials
The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request.
Abbreviations
Adjusted Odds Ratio
confidence interval
Crude Odds Ratio
hepatitis B virus
hepatitis C virus
voluntary blood donors
World Health Organization
voluntary non-remunerated blood donors
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Acknowledgements
The authors would like to express a great gratitude to staffs of North Gondar District Blood Bank for their contribution during the data collection. The authors are also grateful to thank all the study participants and the University of Gondar for giving this opportunity to conduct this study.
The author(s) received no specific funding for this work.
Author information
Bamlaku Enawgaw and Elias Shiferaw equally contributed to the research
Authors and Affiliations
Department of Hematology& Immunohematology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, P.O. Box 196, Gondar, Ethiopia
Bamlaku Enawgaw, Aregawi Yalew & Elias Shiferaw
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BE and ES participated in designing the study, supervised the data collection, analyzed, interpret and write up the manuscript. AY involve in proposal development, data collection and entry of data for analysis. BE and ES are the joint first authors of the paper. All authors read and approved the final manuscript.
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Correspondence to Bamlaku Enawgaw .
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The research was conducted after securing ethical approval letter from Research and Ethical Review Committee of School of Biomedical and Laboratory Science, University of Gondar. Permission was asked from North Gondar District blood bank and written informed consent had been obtained from each study participant. To ensure confidentiality of participants’ information, anonymous typing was applied whereby the name of the participant and any identifier of participants were not written on the questionnaire, and during the interview to keep the privacy, they were interviewed alone.
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Supplementary information
Additional file 1..
Knowledge and attitude questions response of blood donors towards blood donation at North Gondar District Blood Bank, Northwest Ethiopia.
Additional file 2.
Blood donation practice of blood donors North Gondar District Blood Bank, Northwest Ethiopia.
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Enawgaw, B., Yalew, A. & Shiferaw, E. Blood donors’ knowledge and attitude towards blood donation at North Gondar district blood bank, Northwest Ethiopia: a cross-sectional study. BMC Res Notes 12 , 729 (2019). https://doi.org/10.1186/s13104-019-4776-0
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Blood Banking
What is blood banking.
Blood banking is the process that takes place in the lab to make sure that donated blood, or blood products, are safe before they are used in blood transfusions and other medical procedures. Blood banking includes typing the blood for transfusion and testing for infectious diseases.
Facts about blood banking
According to the American Association of Blood Banks as of 2013:
About 36,000 units of blood are needed every day.
The number of blood units donated is about 13.6 million a year.
About 6.8 million volunteers are blood donors each year.
Each unit of blood is broken down into components, such as red blood cells, plasma, cryoprecipitated AHF, and platelets. One unit of whole blood, once it's separated, may be transfused to several patients, each with different needs.
Annually, more than 21 million blood components are transfused.
Who are the blood donors?
Most blood donors are volunteers. However, sometimes, a patient may want to donate blood a couple of weeks before undergoing surgery, so that his or her blood is available in case of a blood transfusion. Donating blood for yourself is called an autologous donation . Volunteer blood donors must pass certain criteria, including the following:
Must be at least 16 years of age, or in accordance with state law
Must be in good health
Must weigh at least 110 pounds
Must pass the physical and health history exam given before donation
Some states permit people younger than 16 or 17 years to donate blood, with parental consent.
What tests are done in blood banking?
A certain set of standard tests are done in the lab once blood is donated, including, but not limited to, the following:
Typing: ABO group (blood type)
Rh typing (positive or negative antigen)
Screening for any unexpected red blood cell antibodies that may cause problems in the recipient
Screening for current or past infections, including:
Hepatitis viruses B and C
Human immunodeficiency virus (HIV)
Human T-lymphotropic viruses (HTLV) I and II
West Nile virus
Chagas disease
Irradiation to blood cells is performed to disable any T-lymphocytes present in the donated blood. (T-lymphocytes can cause a reaction when transfused, but can also cause graft-versus-host problems with repeated exposure to foreign cells.)
Leukocyte-reduced blood has been filtered to remove the white blood cells that contain antibodies that can cause fevers in the recipient of the transfusion. (These antibodies, with repeated transfusions, may also increase a recipient's risk of reactions to subsequent transfusions.)
What are the blood types?
According to the American Association of Blood Banks, distribution of blood types in the U.S. includes the following:
O Rh-positive - 39%
A Rh-positive - 31%
B Rh-positive - 9%
O Rh-negative - 9%
A Rh-negative - 6%
AB Rh-positive - 3%
B Rh-negative - 2%
AB Rh-negative - 1%
What are the components of blood?
While blood, or one of its components, may be transferred, each component serves many functions, including the following:
Red blood cells. These cells carry oxygen to the tissues in the body and are commonly used in the treatment of anemia.
Platelets. They help the blood to clot and are used in the treatment of leukemia and other forms of cancer.
White blood cells. These cells help to fight infection, and aid in the immune process.
Plasma. The watery, liquid part of the blood in which the red blood cells, white blood cells, and platelets are suspended. Plasma is needed to carry the many parts of the blood through the bloodstream. Plasma serves many functions, including the following:
Helps to maintain blood pressure
Provides proteins for blood clotting
Balances the levels of sodium and potassium
Cryoprecipitate AHF. The portion of the plasma that contains clotting factors that help to control bleeding.
Albumin, immune globulins, and clotting factor concentrates may also be separated and processed for transfusions.
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2.6 Conclusions. The blood bank plays an important role in patient care. Transfusion-related errors have serious consequence for patients, including death. Proper identification of the patient and blood products is critical in avoiding such transfusion-related reactions. Most of the errors occur outside the blood bank, so communication between ...
Background: The AABB Clinical Transfusion Medicine Committee (CTMC) compiles an annual synopsis of the published literature covering important developments in the field of transfusion medicine (TM) for the board of director's review. This synopsis is now made available as a manuscript published in TRANSFUSION. Study design and methods: CTMC committee members review original manuscripts ...
During this period, Blundell personally acknowledged two of his medical colleagues Charles Waller and Edward Doubleday as being strong supporters of the use of blood transfusion. This paper outlines the roles that these two men played in the early history of blood transfusion. 38515397. March 22, 2024: Transfusion Medicine.
Dissertation Topics in Blood Banking - Free download as PDF File (.pdf), Text File (.txt) or read online for free.
Accordingly, RBC transfusion, first performed over 300 years ago, remains a fundamental life-saving intervention in medicine. Until the early 1980s, RBC transfusion was considered to be practically risk-free and a truly effective intervention in patients with active bleeding or anemia due to a variety of reasons in the intensive care field.
The seeming duality of transfusion medicine as both a remarkably consistent and a notably dynamic clinical field is fascinating. Over a century ago, Karl Landsteiner discovered the ABO blood group by mixing red blood cells and sera from different individuals and observing agglutination, and this method, albeit with refinements, to characterize both red blood cells and antibodies against them ...
Thesis Topic in Blood Banking - Free download as PDF File (.pdf), Text File (.txt) or read online for free. Struggling with your thesis topic in blood banking is a common challenge due to the vast amount of information available and high standards required. Blood banking covers many complex areas of study from transfusion medicine to donor recruitment.
Blood Bank Thesis Topics - Free download as PDF File (.pdf), Text File (.txt) or read online for free. blood bank thesis topics
An analysis report on the bloo d banks in India has been presented to improve the. blood transfusion systems in India. For this study we take into account the b lood bank data available on the ...
Objective Blood transfusion saves millions of lives. But, the need and the actual number of donations are not balanced in Ethiopia. The actual reason is not clearly assessed; however, level of knowledge and attitude may be the main contributing factors. Thus, the current study aimed to assess blood donors' knowledge and attitude towards blood donation at North Gondar district blood bank ...
2016-04-01. Biochemical investigations on the regulatory mechanisms of red blood cell (RBC) and platelet (PLT) metabolism have fostered a century of advances in the field of transfusion medicine. Owing to these advances, storage of RBCs and PLT concentrates has become a lifesaving practice in clinical and military settings.
Consult the top 50 dissertations / theses for your research on the topic 'Blood bank.'. Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.
Request an Appointment. 410-955-5000 Maryland. 855-695-4872 Outside of Maryland. +1-410-502-7683 International. Find a Doctor. Blood banking is the process that takes place in the lab to make sure that donated blood, or blood products, are safe before they are used in blood transfusions and other medical procedures.
Also, doctor can use this system to serve blood bags to their patient and monitor the details. of the donor. The main advantages of the system are: Blood bank staff can find and manage the donor ...
Special Topic. 101CE: Look Before You Leap with Rich Haspel 101CE: Look Before You Leap with Rich Haspel ... I created Blood Bank Guy in 1998 to teach the essentials of Transfusion Medicine to those who are "learners" in the field. If you are looking for help, you are in the right place! Recent Podcasts. 103: Glaucomflecken! with Will and ...