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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 7
| Issue : 2 | Page : 169-173 |
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Incidence and analysis of acute transfusion reactions in a hospital-based hemovigilance system at a Tertiary Care Center in Bangladesh: A 5-year retrospective evaluation
Tamanna Afroz1, Rakia Hossain Ishra2, Abu Jafar Mohammed Saleh3
1 Department of Transfusion Medicine, Evercare Hospital Dhaka, Dhaka, Bangladesh
2 Ph.D. Researcher, University of Southern Queensland, Queensland, Australia
3 Department of Hematology and Stem Cell Transplant, Evercare Hospital Dhaka, Dhaka, Bangladesh
| Date of Submission | 28-Jul-2022 |
| Date of Decision | 22-Aug-2022 |
| Date of Acceptance | 07-Oct-2022 |
| Date of Web Publication | 5-Nov-2022 |
Correspondence Address:
Tamanna Afroz
Department of Transfusion Medicine, Evercare Hospital Dhaka, Dhaka
Bangladesh
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/gjtm.gjtm_57_22
Background and Objectives: Blood transfusion is a life-saving intervention but may cause nonfatal to fatal untoward events. Therefore, for safe blood transfusion, various adverse reactions need to be identified and steps should be taken to reduce such events. The aim of this study was to determine the incidence and analyze the types of acute transfusion reactions (ATRs) with associated factors. Patients and Methods: All ATRs reported to the transfusion medicine department from January 2016 to December 2020 were retrospectively reviewed and analyzed. The incidence of ATRs and its associated factors were assessed. Results: During the study period, a total of 39,070 units of blood were issued, out of which there was an incidence of 0.24% (n = 95) ATRs mostly seen in females and older patients aged above 60 years. Most common ATR was febrile nonhemolytic transfusion reactions (51.6%, n = 49), followed by allergic reaction (35.8%, n = 34). The most common symptom was chills and rigor (41.1%). The frequency of reactions was significantly higher with packed red blood cell transfusion (62.1%). Patients with previous transfusion history (n = 63, % = 66.3, P = 0.711) had more ATRs. Conclusion: By this study, the authors want to create awareness among health personnel involved in the transfusion chain is necessary to establish a proper hemovigilance system.
Keywords: Bangladesh, hemovigilance, transfusion reaction
How to cite this article:
Afroz T, Ishra RH, Mohammed Saleh AJ. Incidence and analysis of acute transfusion reactions in a hospital-based hemovigilance system at a Tertiary Care Center in Bangladesh: A 5-year retrospective evaluation. Glob J Transfus Med 2022;7:169-73 |
How to cite this URL:
Afroz T, Ishra RH, Mohammed Saleh AJ. Incidence and analysis of acute transfusion reactions in a hospital-based hemovigilance system at a Tertiary Care Center in Bangladesh: A 5-year retrospective evaluation. Glob J Transfus Med [serial online] 2022 [cited 2023 Mar 28];7:169-73. Available from: https://www.gjtmonline.com/text.asp?2022/7/2/169/360491 |
| Introduction | |  |
Blood transfusion is an effective and indispensable part of modern health care. However, it could be a double-edged sword as it carries a minute risk for nonfatal to fatal adverse reactions. A transfusion reaction (TR) is defined as any undesirable events occurring in a patient during or after the administration of blood components. The severity varies with age, gender, previous transfusions, diagnosis, type of different blood components, and clinical condition of patients. They can be classified as acute and delayed based on the time of onset. Acute TRs (ATRs) present as adverse signs or symptoms occurring during or within 24 h after transfusion. Acute hemolytic TR (AHTR), allergic reactions, febrile nonhemolytic TR (FNHTR), transfusion-associated circulatory overload (TACO), and transfusion-related acute lung injury (TRALI) are various types of ATRs.[1] The most frequent symptoms are fever, chills and rigor, rash, and pruritus which usually resolve promptly without specific treatment.
A TR may cause a delay in treatment, extend hospital stay, and increase costs. There are no definite predictive factors but patients with repeated transfusions and multiparous women are at high risk of ATRs. Elderly and patients with cardiovascular disease are at risk for volume overload and multi-transfused patients for FNHTR. Literature search reviewed, females between 15 and 45 years are most frequently transfused in “low and middle income” countries.[2]
Each hospital should establish a system for monitoring, recording, and reporting adverse TRs known as hemovigilance system. The main objective is to detect, collect, and analyze undesirable events associated with blood transfusion. The ultimate goal is to ensure safe blood transfusion for the patients. Currently, hemovigilance is an integral part of quality management systems globally. The approach to hemovigilance varies between countries. The first hemovigilance surveillance system was developed in France in 1994 as a national system of surveillance with a legal obligation to notify every untoward effect.[3] The UK initiated Serious Hazards of Transfusion to report only serious adverse reactions on a voluntary basis. A well-established hemovigilance system in a hospital setup will reduce possible human errors and minimize the incidence of ATRs. It is an essential step toward nationwide hemovigilance. In Bangladesh, few centers have their own hospital hemovigilance program.
Aims and objectives
The aim is to determine the incidence and analyze the types of ATRs with associated factors occurring in patients who required blood transfusions. The workup would enable us to develop insight into ATR patterns and will help to correct their cause and improve patient safety during a blood transfusion.
| Methodology | | |
Study setting
After obtaining clearance from the ethics and research committee, the study was conducted in the Transfusion Medicine Department (TMD) of Evercare Hospital Dhaka, Bangladesh. Evercare Hospital is one of the largest tertiary care hospitals in Dhaka and the only JCI-accredited hospital in the country. The hospital acts as a referral center. TR is one of the quality indicators for the department. Data from January 2016 to December 2020 were retrieved retrospectively from the archival records and were analyzed.
Study population
The study included all patients who received a blood transfusion at our facility during admission and experienced ATRs and reported in TMD. Exclusion criteria were incomplete or limited medical data such as age, gender, symptoms, vitals, diagnosis, and history of the previous transfusion (if any).
Standard procedure for management and documentation of acute transfusion reaction event
Before transfusion, the units are cross-checked for the patient's details (name, age, and UHID), blood grouping of patient and blood unit, bag unit number, expiration date, and inspect the unit for hemolysis, discoloration, clot, and leakage. During the transfusion, vitals are monitored within 15 min after the start of the transfusion and then half an hour till the end.
In the event of a reaction, a TR form is being filled by the concerned department with information pertaining to the patient's data, type of component issued, time and date of transfusion started, time of reaction, amount remaining in the bag, and sign symptoms of reaction with past transfusion history as well as pre- and posttransfusion vital signs. The form and posttransfusion blood sample (2 ml ethylenediaminetetraacetic acid vial and 2 ml redvial) along with leftover blood bag and transfusion set are immediately sent to TMD for detailed work up. Patients' additional clinical details and diagnostic records were collected from the hospital information system.
The TMD performs a thorough evaluation with all documents. Possible clerical error, posttransfusion sample for hemolysis, and comparison with pre- and posttransfusion samples are checked. Blood grouping, cross-matching, and direct antiglobulin tests from pre- and post-transfusion samples are rechecked. Bacteriological testing by culture from a blood bag is done by the microbiology department. Details patient's history and clinical conditions are recorded. For suspected hemolytic TR, further investigations are suggested such as s. bilirubin, lactate dehydrogenase, haptoglobin, peripheral blood smear examination for the presence of schistocytes and spherocytes, and urine Hb by dipsticks. Based on the mentioned clinical features and laboratory reports, the reactions are classified according to AABB[4] definitions and the data are submitted to the quality control department.
Statistical analysis
The data collected for this study were analyzed for frequency, percentage, mean, and standard deviation. The statistical software used was SPSS version 27.0 (IBM). P < 0.05 was considered significant.
| Results | | |
During the study period, a total 39,070 of units were issued from TM. The incidence of ATRs was 0.24% that fulfilled the inclusion and exclusion criteria. There was a female preponderance (62.1%) in the frequency of reactions over the male (37.9%) [Table 1].
Most reactions were noticed in older patients who were above 60 years (38.9%) [Table 1]. The most common symptom was chills and rigor (41.1%), followed by fever (37.9%) and urticaria (20) [Table 2]. The frequency of reactions was significantly higher with packed red blood cells (PRBCs) (62.1%) [Table 3]. The mean volume of blood at which the reaction had occurred was 150 ml. No hemolytic TRs were reported during the study period. Majority of nonhemolytic reactions were FNHTR (51.6%, n = 49). Allergic reactions were manifested as urticaria, rash, and pruritus, the most common was urticaria. There was no reaction due to cryoprecipitate transfusion. Blood culture analysis has shown no findings of bacterial growth in any case.
FNHTR and allergic reactions were more common in a female with an age range of 26–45 years. TACO occurred more in >60-year-old male patients [Table 5] and [Table 6]. O-positive patients had most reactions (34.7%) and had more FNHTR (42.9%) and TACO (66.7%) and “A” positive had more allergic (32.4%) and Transfusion associated dyspnea (TAD) (50%) [Table 7].
The most common indication was acute bleeding due to various reasons followed by anemia without a diagnosis of an underlying cause. In the study, there was no transfusion-related mortality in the first 24 h followed by transfusion. Patients who had previous transfusion history (n = 63, % = 66.3, P = 0.711) had more ATRs and most common reaction in this group was FNHTR (52.4%). Gastroenterology department had the highest TRs (21.1%) [Figure 1].
| Discussion | | |
Incidence of ATRs varies widely according to pathophysiology, symptoms, and severity from 0.2% to 10% and mortality is approximately 1 in 250,000.[5] The frequency of ATRs in our study was 0.24% (95 out of 39,070) which is similar to other published results.[6] In our hospital, yearly around 8000 blood units are issued to various departments. No clerical error was noticed in any of the 95 cases due to the institutional policy of double-checking at multiple levels. Similarly, there are different studies where no clerical errors were noticed.[7],[8] Some of ATRs were managed by medications whereas the remaining subsided on its own.
FNHTR, which is defined as an otherwise unexplained fever within the first 4 h of transfusion, was the highest (51.6%; 49 out of 95) among different ATRs. Rigor and other symptoms in the absence of fever were also included as FNHTR. FNHTR is caused due to the release of cytokines during storage from leukocytes or antibodies to donor leukocytes. Literature search revealed the incidence of FNHTR varies from 17% to 54%.[9] Possible reasons for the variation in the frequency of FNHTR among different studies include differences in recording symptoms by bedside staff, therapeutic interventions to control fever, and at times due to many causes that are not reported. FNHTR was more common with PRBCs (0.25% of all PRBC transfusions) and whole blood (WB) (0.1% of all WB transfusions). Kumar et al. found 0.04% FNHTR with PRBC, which was lower than that observed in this study.[10] The relatively high incidence of FNHTR could be because of a lack of leukoreduction of the components in our hospital. Leukocyte-depleted red blood cells have a lower incidence of FNHTR.[11],[12] A comparative study on the incidence of FNHTR in leukoreduced versus nonleukoreduced blood components showed that the incidence is 0.12% in nonleukoreduced and 0.08% in prestorage leukoreduced blood.[13] The present study with transfusion of nonleukoreduced red cells (WB/PRBC) has shown the overall risks for FNHTR to be 0.12% (49 out of 39,070) which is comparable to the reported data. All FNHTR patients were managed by paracetamol.
Allergic reactions can occur in up to 2% of transfusions.[14] In the present study, only mild-type allergic reactions were observed in 35.8% of patients with ATRs which were managed symptomatically. In most studies, allergic reactions occurred with all types of components attributing it to plasma proteins in the component. In our study, the majority were due to WB (0.05%, 19 out of 39,070). In patients with a history of previous allergic reactions to transfusion, prophylactic administration of antihistamine 30 min before, or the use of washed blood components may be beneficial.[15],[16] TACO was seen in six cases in our study giving an incidence of 0.01% (6/39,070). Transfusion-related hypervolemia was reported in 0.31–0.42/1000 patients.[17] Our patients with TACO mainly belonged to the elderly group (age >60 years) with severe anemia and the probable explanation in them was already being in a hyperkinetic state with the heart being intolerant to even a slight increase in blood volume. Hence, rapid transfusion should be avoided and it is necessary to follow the AABB recommendation of infusing PRBCs at a rate of 2–4 ml/min in these cases. TAD is defined by respiratory distress within 24 h of transfusion that does not meet the criteria of TRALI, TACO, or allergic reaction or other known causes.[18] This type of reaction was seen in 4.2% of all ATRs. Hypotension can be a manifestation of several TRs such as AHTR, septicemia, TRALI, or anaphylaxis. We reported it as an isolated sign in two cases with PRBC transfusion.
Blood components that contain leukocytes have the potential to cause reactions. We observed that PRBCs were most commonly associated with ATRs as it has the highest demand [Table 4]. FNHTR was the most common reaction in this group (67.8%). WB, PC, and FFP were associated with more allergic reactions. The introduction of leukoreduction at our hospital could possibly enable us to reduce the incidence of ATRs in general and febrile reactions in particular. Two-thirds of patients with ATRS had prior transfusion history which is an important factor that influences the occurrence of TR. Menis et al. and Arewa et al. reported numbers of units transfused per patient were statically significant to the occurrence of ATR.[19],[20] Individuals with a history of repeated transfusions will have exposure to different antigens such as humanleukocyte antigens, platelet antigens, and plasma proteins, and sensitization could lead to the formation of alloantibodies. These antibodies account for many reactions including mild allergic, FNHTR, and anaphylactic reactions. Our study was in line with the result of other studies that similarly found O blood type as the mostly found blood type in patients with ATRs.[21],[22] ATRs were more in the elderly age group.
The majority of the reactions were reported to our department only when the reaction occurred during transfusion. Some reactions may occur after 10 h or more, therefore, it is necessary to be vigilant during and after transfusion. Underreporting of nonspecific and minor TRs has been documented.[10],[21] This may be due to a lack of awareness or an inadequate feedback system. Careful evaluation of any suspected event of transfusion should be referred to the TM physician for inspecting each case and discuss it promptly with the attending physician. Another important factor is storage condition. Unmonitored storage in wards could cause deterioration of red cell units and could be a risk. Hence, awareness among the bedside staff is essential.
Blood transfusion service in Bangladesh started in 1950. Maximum (58%) blood transfusion centers belong to the public sector and are integrated with hospitals at multilevel and blood transfusion centers in the private sector (42%) are integrated to medical colleges, specialized clinics, and stand-alone blood centers. All centers in the public sector are coordinated and supervised by the National Safe Blood Transfusion Program. All licensing private blood transfusion centers operated after getting license from the licensing authority, Directorate General of Health Services. No centralized or regional collection, testing, and distribution system exist at present. National Transportation Safety Board developed national hemovigilance software, but due to the COVID-19 pandemic, progress was slow and delayed.
In our hospital, we have our own hemovigilance program. Our hospital transfusion committee promotes preventive measures against the occurrence of these reactions. There is a need to sensitize all the health personnel involved in the transfusion chain for more thorough reporting of all major and minor transfusion adverse events. This requires collaboration between TM physician and their clinical counterpart so that a proper hemovigilance system can be achieved. Adoption of more advanced equipped methods and sensitive technologies with the improvement of existing ones will help to bring down unwanted events. This study suggested there were many risk factors to cause TR, so it is necessary to give blood transfusion with proper indication.
Limitations
We could not obtain the accurate figure of ATRs as clinical reporting was the only source of information. Active surveillance was not done in our study.
| Conclusion | | |
In this study, we reported the patient-focused hemovigilance system implemented in our hospital. The frequency of ATRs in our patients was 0.24%. Majority of reactions were due to PRBC transfusion. FNHTR and allergic reactions were the most common ATRs. The hemovigilance system plays a very important role in improving blood safety. Adequate, skilled, and dedicated manpower and an encouraging environment for monitoring and reporting of adverse events and near-misses in a supportive, nonblaming learning culture is required to have an effective hemovigilance system. The authors strongly feel that there is a need for establishing a national hemovigilance system in our country that can be helpful in the detection of untoward transfusion events, as well as in the decision to take appropriate preventive measures.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]
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