|Year : 2023 | Volume
| Issue : 2 | Page : 150-155
Blood transfusion reactions and institutional hemovigilance protocols: A 2-year retrospective single center audit
John C Aneke1, Chisom G Chigbo2, Perpetua O Emeh1, Francis Ifediata1, Chilota C Efobi1, Ugochinyere J Chilaka1, Nkechinyere T Ibekwe3, Theodora U Ezeh1, Chiamaka B Aneke4
1 Department of Hematology and Blood Transfusion, Nnamdi Azikiwe University, Teaching Hospital, Nnewi, Nigeria
2 School of Public Health, University of Port-Harcourt, Rivers State, Nigeria
3 Department of Medical Records, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria
4 Respiratory Laboratory Unit, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria
|Date of Submission||21-Sep-2022|
|Date of Decision||05-Nov-2022|
|Date of Acceptance||28-Dec-2022|
|Date of Web Publication||21-Mar-2023|
Chilota C Efobi
Department of Hematology and Blood Transfusion, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State
Source of Support: None, Conflict of Interest: None
Background: Blood transfusion reactions contribute significantly to the morbidity and mortality of both in- and outpatients in hospitals globally. Developing adequate protocols for detecting and reporting this complication is key to attaining global blood transfusion safety. Objective: The objective of the study was to review the frequency of blood transfusion reactions and the adequacy of institutional hemovigilance efforts in a Nigerian hospital. Materials and Methods: Records of patients that had blood transfusion reactions (cases) and those that did not (controls) were analyzed over a 2-year period. Sociodemographic information, transfusion and admission histories, primary diagnoses, as well as transfusion reaction details (where applicable) were recorded. Data were analyzed using STATA 16.1 (StataCorp. 2019, Stata Statistical Software: Release 16, College Station, TX: StataCorp LLC). Sociodemographic characteristics were presented in frequency tables and charts, whereas relationships between study variables were compared using the Chi-square and the Person Correlation. P value less than 0.05 was considered to be statistically significant (confidence level = 95%). Results: One death was recorded among the cases during the study, whereas febrile nonhemolytic reactions constituted the most type of reaction (41.5%). Only 37.5% of reactions were investigated, and none was reported to the hospital blood transfusion/hemovigilance committee. There was no significant association between the study-related variables and the type of reaction or the likelihood of experiencing a new reaction with subsequent transfusions (P values all > 0.05). Conclusion: Febrile reactions are the commonest complication of blood transfusion in our data set; institutional hemovigilance efforts remain suboptimal and should be further strengthened.
Keywords: Hemovigilance, transfusion audit, transfusion reaction, transfusion safety
|How to cite this article:|
Aneke JC, Chigbo CG, Emeh PO, Ifediata F, Efobi CC, Chilaka UJ, Ibekwe NT, Ezeh TU, Aneke CB. Blood transfusion reactions and institutional hemovigilance protocols: A 2-year retrospective single center audit. Int J Med Health Dev 2023;28:150-5
|How to cite this URL:|
Aneke JC, Chigbo CG, Emeh PO, Ifediata F, Efobi CC, Chilaka UJ, Ibekwe NT, Ezeh TU, Aneke CB. Blood transfusion reactions and institutional hemovigilance protocols: A 2-year retrospective single center audit. Int J Med Health Dev [serial online] 2023 [cited 2023 Jun 3];28:150-5. Available from: https://www.ijmhdev.com/text.asp?2023/28/2/150/372154
| Introduction|| |
Blood transfusion has been established as a life-saving therapy over the years. In fact, it is estimated that annually, this medical intervention saves an estimated 100,000 lives, globally. These range from the trauma, obstetrics, and pediatric patients as well as others with various cancers and organ failure, who regularly present to the emergency room with potentially life-threatening bleeding and/or anemia.
Despite these well-established benefits, blood transfusion therapy is associated with a number of potentially fatal complications, collectively known as blood transfusion reactions. Blood transfusion reactions can be classified into immediate or delayed, hemolytic or nonhemolytic, and immune or nonimmune, depending on its time frame of occurrence and pathogenesis. Immediate transfusion reactions typically occur within 24 h of a transfusion, whereas hemolytic and immune reactions are associated with red cells destruction and antigen/antibody interactions, respectively.
An earlier prospective study of 462 transfusions at the Obafemi Awolowo University Teaching Hospital, Ile-Ife, Nigeria, showed a frequency of transfusion reactions of 8.7% (40 cases), with acute transfusion events (febrile nonhemolytic transfusion reactions [FNHTR]) being the most prevalent (65%). Indeed, reports from other parts of sub-Saharan Africa have similarly shown the predominance of acute transfusion reactions with prevalence rates of 3.5% and 2.6% reported in Namibia and Democratic Republic of Congo, respectively., Mortality data from blood transfusion reactions in Africa unfortunately remain high with up to 65 deaths (1.3 per 1000 blood units) reported in Burkina Faso in 2018.
A number of developed countries (particularly United States of America and Canada) have developed robust and efficient surveillance systems to detect, monitor, and evaluate adverse events that could occur from blood transfusion., In contrast, hemovigilance systems remain poorly developed and fragmented in most countries in Africa. Admittedly, a number of countries in Africa have successfully ramped up their pretransfusion testing for transfusion transmissible infections; unfortunately commensurate quality systems for handling adverse transfusion-related events remain rudimentary.,
In Nigeria, the National Blood Transfusion Service is the master orchestra that drives blood transfusion safety and country-wide hemovigilance renaissance. It has continued to advocate for a coordinated institution-based transfusion quality improvement measures, through sets of guidelines that were first published in December 2006. The consistency and efficiency with which these guidelines are deployed and implemented nationally however remain to be seen.
The objective of this study was to retrospectively review the frequency of blood transfusion reactions in a Nigerian tertiary care facility over a 2-year period as well as to evaluate the adequacy of institutional hemovigilance efforts.
| Materials and Methods|| |
Design and study setting
This was a cross-sectional descriptive and analytical study using blood bank data and case notes of patients who had a blood transfusion reaction at the Nnamdi Azikiwe University Teaching Hospital, NAUTH, Nnewi, from January 2019 to December 2020. Those that had a documented blood transfusion reaction constituted the cases, whereas those who did not were designated as the controls.
The NAUTH is a 500-bed capacity tertiary healthcare facility located in the cosmopolitan town of Nnewi, Anambra State, South-East, Nigeria. The State is strategically nestled between five other States (Imo, Kogi, Edo, Enugu, and Rivers) and so receives referrals from these. Anambra State has a population of 4,177,828 (based on the 2006 National Census), consists predominantly of the Igbo ethnic group, and covers an area of approximately 4,844 km2.
Subject selection/study protocol
The study subjects who were used as cases were patients who had at least one documented blood transfusion reaction within the study period, whereas controls included age- and sex-matched patients who received a transfusion but had no record of any reactions. Subjects that satisfied the inclusion criteria were extracted from the blood bank records, whereas their case notes were retrieved from the medical records department. The following study-related information was recorded for analysis: sex, age, primary diagnoses, length of hospitalization (in days), the component of blood that was transfused, the type of blood transfusion reaction, the total number of blood units received, treatment given for the transfusion reaction, the outcome of the transfusion reaction (mortality or recovery), information on the fate of subsequent blood transfusions, and what feedbacks were provided (if any) to the managing physician or the hospital blood transfusion/hemovigilance committee. The primary diagnoses were grouped under subheadings such as cancers, benign hematology (aplastic anemia, sickle cell disease, idiopathic thrombocytopenic purpura, and undetermined anemias), gynecologic/obstetric (postpartum/antepartum hemorrhage, preeclampsia/eclampsia, menorrhagia, and fibroid), and others (enterocutaneous fistula, sepsis, and unspecified diagnoses). The laboratory record of each participant was reviewed to obtain the total number of blood pints that the patient received as well as the tests that were done on the unit(s) that reacted and the results of such tests (where applicable). All information was recorded in a case record form, without patient’s name or any other patient identifiers.
Inclusion criteria included all documented blood transfusion reactions that occurred within the study period; patients with incomplete laboratory/clinical details and those whose reaction occurred outside our hospital were excluded from the study. Ethical approval was obtained from our institutional review board with ref number: NAUTH/CS/66/VOL15/VER3/150/2022/103, and study-related information was handled with strict confidentiality and ethical standards.
Data obtained from the study were analyzed using STATA 16.1 (StataCorp. 2019, Stata Statistical Software: Release 16, College Station, TX: StataCorp LLC). Sociodemographic characteristics and other details of the participants such as sex, type of transfusion reaction, the primary diagnosis, and the treatment given were presented in frequency tables and charts where necessary. All continuous variables such as age and the number of blood pints received were subjected to tests of normality. Normally distributed continuous variables were represented as mean ± standard deviation, whereas nonnormally distributed continuous variables were represented as median and interquartile range. The study-related variables were compared in cases and controls by using the Chi-square, whereas relationship between age, primary diagnosis, the number of pints transfused, and the occurrence of blood transfusion reaction was explored by the Pearson correlation. P value less than 0.05 was considered to be statistically significant (confidence level = 95%).
| Results|| |
The mean ages of cases and controls were 41.07 ± 17.21 years and 40.86 ± 24.56 years, respectively [Table 1]. Among the cases, those in the 21–30 years age bracket (28.1%) and females (66.7%) had the largest representation. The predominant primary diagnoses in the cases was cancers (37.5%), followed by benign hematology and gynecology/obstetrics cases (18.8%, respectively), whereas renal diseases and trauma (6.2% respectively) were the least. In the controls, the most frequent primary diagnoses were cancers and surgical conditions, which constituted less than a fifth, 17.1%, respectively.
The most common indication for blood transfusion in the cases and controls was anemia (84.4% and 74.5%, respectively). In terms of the blood fraction that was given to the study participants, whole blood ranked highest in both cases and controls (45.5% vs. 62.6%, respectively), whereas platelet concentrate was the least, at 3.0% in cases and 0.0% in controls.
The median (interquartile range) of the length of hospitalization, blood pint transfused, pretransfusion hematocrit, and absolute neutrophil count (ANC) in cases were 16 (7–28) days, 3 (2–4) pints, 22.5 (20–28) L/L, and 2.0 (1.6–3.9) × 109/L, respectively. The longest length of hospitalization in cases was 22 days and above (41.9%). Correspondingly, the median (interquartile range) of the length of hospitalization, blood pint transfused, pretransfusion hematocrit, and ANC in the controls were 14 (3–257) days, 3 (0.28–16) pints, 22.0 (0.17–42) L/L, and 4.8 (2.2–13.6) × 109/L, respectively. The longest length of hospitalization in the controls was 7–21 days (51.4%). In this study, a little above half (58.1%) of cases and about two thirds (65.7%) of controls received ≤ 3 pints of blood in total during each admission cycle. There were no statistically significant differences in the length of hospitalization and the number of blood pints transfused in cases and controls (P values = 0.411 and 0.319, respectively).
Only one death (3.1%) was recorded among the cases during the study (and none in the controls); febrile nonhemolytic reactions constituted the most common type of reaction that was recorded (41.5%). A larger proportion of study participants received further transfusions after the experiencing a reaction (75.0%), and an equally larger number did not show any record of a reaction following subsequent transfusion challenge (90.6%). Following a blood transfusion reaction, about half of the participants (53.3%) had their transfusions permanently discontinued. The relationship between the occurrence of febrile hemolytic transfusion reaction and the tendency to continue the transfusion approached statistical significance (P = 0.098; [Table 2]). Evidence of further investigation of a blood transfusion reaction was found in only 37.5% of participants; no case of blood transfusion reaction was reported to the hospital blood transfusion committee within the study period.
|Table 2: Chi-square analysis showing the relationship between the likelihood of transfusion being continued and the type of reaction|
Click here to view
Hydrocortisone and paracetamol were administered to about a quarter of the patients (26.7% and 25.3%, respectively) postreaction, whereas oxygen and frusemide were given in 2.7% of cases, respectively.
There was no statistically significant association between the age, gender, total pint transfused, pretransfusion hematocrit and ANC, the length of hospitalization, and primary diagnoses of study participants with the type of reaction that was recorded (P values all > 0.05). Correspondingly, there was no significant association between the age, gender, type of blood fraction transfused, and primary diagnoses of study participants and the likelihood of experiencing a new reaction at subsequent blood transfusions (P values all > 0.05; [Table 3]).
|Table 3: Chi-square analysis showing the relationship between age, gender, type of blood given, primary diagnosis, and development of a new reaction on re-challenge|
Click here to view
| Discussion|| |
Blood transfusion medicine globally continues to undergo quality improvement and regular system refinements, which includes the introduction of more stringent transfusion indicators to ensure that donor units are optimally utilized. These measures are predicated on the decreasing global blood donor unit inventory as well as the potential hazards that may be associated with the transfusion process.
In this study, the predominant primary diagnosis among the study participants was cancers (37.5%), whereas anemia (84.4%) was the frequent transfusion indicator. The blood transfusion requirement in most hospitals tends to be dependent on the case load and nature of disease conditions that are managed in such facility. Indeed, anemia and a higher overall blood transfusion burden are associated with cancer-related care and management. Anemia is not only a common presentation in patients with cancer but also a determinant of disease-related morbidity and survival. The contribution of anemia to the overall cancer-related treatment cost has led to the introduction of interventions aimed at reducing the use of regular blood transfusions such as setting lower transfusion triggers and the use of growth factors, particularly erythropoietin., A number of these practices have become well established in more developed countries and resulted in a significant decrease in transfusion rate, related complications, and cost, with no compromise on patient survival. At the Anderson Cancer Center in the United States, for instance, a record 50% reduction in cancer-related cost was observed following the adoption of some of these interventions. As laudable as these interventions may appear, applying same to less resource endowed parts of the world, including sub-Saharan Africa, may be a herculean task considering its regional peculiarities, which include numerous socioeconomic, political, and leadership issues. Additionally, there is an increasing global emphasis on the use of blood component therapy, instead of the more traditional whole blood transfusions. Unfortunately, in this study, whole blood (45.5%) and sedimented cells (39.4%) were the predominant types of transfusion recorded. Blood fractionation in addition to ensuring a more appropriate use of blood units can also mitigate some transfusion reactions such as allergic/anaphylactic reactions.
FNHTR was the commonest reaction encountered in this study (41.5%). This corresponds with a number of earlier studies done in Nigeria and other parts of the world, and may allude to the predominant use of units that had not been leukodepleted in these healthcare settings. The use of leukodepletion (either prestorage or poststorage) is an established way of reducing the number of white cells in blood units, hence mitigating the occurrence of FNHTR. Blood transfusion-related deaths were reported in 0.14 % of patients in earlier transfusion audits in sub-Saharan Africa. Deaths from blood transfusion reactions tend to be associated with more severe reactions such as transfusion-related acute lung injury and anaphylactic reactions. In this study, only one death (3.1%) was reported in a patient that was transfused; the authors could however not ascertain whether this death was secondary to the primary diagnosis or the transfusion reaction, because of the retrospective nature of this study. Seventy-five percent of cases had a second transfusion episode (after the index reaction), of which 90.6% did not experience new reactions. Correspondingly, there was no statistically significant relationship between the age, gender, type of blood given, the primary diagnoses of participants, and the likelihood of developing a new reaction following a second transfusion challenge in this study (P values all > 0.05). These are not entirely uncommon observations in blood transfusion practice, especially where targeted interventions that are known to mitigate transfusion reactions are effectively and proactively deployed. The use of premedication with paracetamol and steroids is a routine in our facility, for patients with a previous history of FNHTR or allergic reaction. These interventions might have dampened the immune processes that are associated with these reactions, resulting in uneventful subsequent transfusion challenge. Interestingly, hydrocortisone (26.7%) and paracetamol (25.3%) were the most common treatment interventions in patients that had a reaction in this study. In addition, the relationship between the occurrence of FNHTR and the likelihood of continuing the blood transfusion approached statistical significance at P = 0.098 [Table 3]. Indeed, the resumption of transfusion after a confirmed FNHTR is common and may even be facilitated by the administration of steroids and antipyretics (as was the observed in this study).
Hemovigilance efforts are a series of institutional transfusion safety protocols that are geared toward preventing transfusion-related morbidity and mortality., It includes transfusion quality measures related to donor procurement, blood unit processing and transfusion, as well as monitoring, reporting, and investigating recipient and donor adverse events., In this study, only 37.5% of blood transfusion reactions had evidence of further investigation to find out the cause, and none was reported to the hospital blood transfusion committee (that oversees the hospital hemovigilance efforts). This is in consonance with the finding from an earlier study in our center, which reported suboptimal knowledge and practice of hemovigilance among healthcare professionals. In contrast, reports from the North America showed more robust blood transfusion surveillance and feedback systems, which have been instrumental in strengthening blood transfusion safety in these countries.,
Limitations of the study
A longer study period of about 10 years, which may have ensured a larger sample population, would have given the study a more statistical power. Also, some potential study participants had incomplete transfusion and/or clinical details because of poor record keeping.
To the best of the authors’ knowledge, this is the first study in Nigeria to access blood transfusion reaction in relation to institutional structure that is in place for hemovigilance.
| Conclusions|| |
Cancer-related anemia remains a substantial contributor to the increased blood transfusion requirement in our patient population, whereas blood fractionation still appears rudimentary, with the predominant use of whole blood and sedimented cells for transfusion. FNHTR continues to top the rank of blood transfusion reactions encountered in this study; its occurrence may be associated with the likelihood of continuing a transfusion.
Our current institutional hemovigilance efforts appear suboptimal and need further refinement and improvement for better performance in order to conform to global standards.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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