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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 6  |  Issue : 2  |  Page : 218-223

The first data of hemovigilance: Appraised from a single center in Bangladesh


1 Department of Transfusion Medicine, Bangabandhu Sheikh Mujib Medical University, Shahbag, Bangladesh, Dhaka, Bangladesh
2 Department of Transfusion Medicine, Addin Medical College and Hospital, Bashundhara Branch, Bangladesh, Dhaka, Bangladesh

Date of Submission13-Aug-2021
Date of Decision30-Oct-2021
Date of Acceptance02-Nov-2021
Date of Web Publication30-Nov-2021

Correspondence Address:
Dr. Sonia Shormin Miah
Department of Transfusion Medicine, Bangabandhu Sheikh Mujib Medical University, Shahbag, Dhaka
Bangladesh
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/gjtm.gjtm_80_21

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  Abstract 


Background and Objectives: Hemovigilance is a prime requirement for safe transfusion practice rather it may be the reflection of laboratory performance in a blood bank. This study is the first report of transfusion errors and adverse reactions recorded in Bangladesh. It is a new approach to collect and analyze the data pertaining to issues associated with blood transfusion in the day care. This study is aimed to perceive the frequency of adverse reactions and the errors associated with its barrier. Methods: This cross-sectional observational study was conducted in the daycare unit of the Department of Transfusion Medicine of Bangabandhu Sheikh Mujib Medical University from July 2018 to June 2019. Any error regarding pretransfusion and transfusion procedure and adverse event following transfusion was noted according to departmental standard operating procedure and collected data were analyzed with Microsoft Excel 2016. Results: Of the 10,762 units of blood component selected for the issue to 6995 patients, 66 units were discarded. For various reasons. Out of 10696 units of blood component transfused, a total of 459 (4.29%) transfusion reactions were observed among which 390 (3.6%) were acute and 69 (0.6%) were delayed. Mild allergic (40.5%) and Febrile nonhemolytic (36.4%) were the most common acute reaction whereas alloimmunization (9.4%) and delayed hemolysis (4.1%) were the most observed delayed transfusion reaction. Among the recipient, transfusion reactions were observed slightly more in males (7.5%) than in females (5%) and the most affected age group was 20–29 years. Conclusion: However, it is not always possible to analyze the relevance of all the transfusions and the outcome of the patient. Now, a developing country like Bangladesh has to face and notify the errors and to solve them in parallel.

Keywords: Analyze, daycare, hemovigilance


How to cite this article:
Miah SS, Doha MA, Islam MA, Sharmin N. The first data of hemovigilance: Appraised from a single center in Bangladesh. Glob J Transfus Med 2021;6:218-23

How to cite this URL:
Miah SS, Doha MA, Islam MA, Sharmin N. The first data of hemovigilance: Appraised from a single center in Bangladesh. Glob J Transfus Med [serial online] 2021 [cited 2022 Aug 10];6:218-23. Available from: https://www.gjtmonline.com/text.asp?2021/6/2/218/331626




  Introduction Top


Blood transfusion has its inherent risk. Previously, the most significant risk of transfusion was transfusion-transmitted infections. However, with technological advances and modern methods of screening of blood and blood components, the risk of transfusion-transmitted infection has minimized. The awareness about transfusion-related infection has greatly improved blood safety. Despite that, transfusion-related adverse events still persist. To identify the causes of transfusion reactions for its effective management, a monitoring system that encompasses the whole transfusion chain needed to be established. This monitoring or surveillance system which is popularly termed as the hemovigilance program has been adopted in many countries[1] as standard procedure for reporting and taking steps to reduce the risk of transfusion reaction.

There has been no hemovigilance program in Bangladesh either institutionally or nationally. There were a few scattered reports of transfusion reaction by several authors in this region but none of them point out the key factors responsible for transfusion reaction.

This study was conducted as an effort toward institutional hemovigilance as we evaluated adverse events related to transfusion occurring in our department of transfusion medicine. We hope that this study will help not only to understand problems regarding transfusion in our setting but also to point out the necessity of implementing an effective hemovigilance program.


  Materials and Methods Top


This retrospective cohort study was done in the daycare unit of the Department of Transfusion Medicine from July 2018 to June 2019.

Any transfusion-related event was duly noted and investigated in accordance with the department's standard operating procedure.

Ethics

Ethical clearance was in accordance with the declaration of Helsinki and approved by the institution.

Any adverse event occurring during or after transfusion of blood or blood components was defined as transfusion reaction. The adverse event was termed acute or chronic if it occurred within 24 h or after 24 h, respectively. Any such event was duly noted and further investigation was done to find out the causes. The investigation included immediate checking of blood bag and patient's document, history taking regarding patient's illness and current symptoms, physical examination of the patient, and laboratory workups. Following serological testing was performed in the transfusion medicine laboratory after a suspected hemolytic transfusion reaction occurred:

  • A direct antiglobulin test on posttransfusion ethylenediaminetetraacetic acid sample before refrigeration immediately on receipt. If the test was positive DAT performed on pretransfusion sample to verify whether sensitization was due to transfusion or preexisting.
  • Repeat grouping and antibody screening of patient's pre- and posttransfusion sample
  • Repeat grouping of samples from the bag.
  • Repeat crossmatching of patient's pre- and posttransfusion sample with donor unit.


For the biochemical test, we separated the patient's pre- and posttransfusion serum and sent it to the biochemistry department in a 5 ml screw-cap plastic vial for estimation of total, direct and indirect bilirubin and estimation of plasma hemoglobin. A physical examination of posttransfusion urine was made and sent for hemoglobin estimation. Patient's blood was also sent for bacterial culture. A chest X-ray P/A view was done to rule out transfusion-related acute lung injury or cardiac overload.

Statistics

The data were analyzed with Microsoft Excel 2016 (MS excel 2016) and presented in tabulated form.


  Results Top


In the study period from July 2018 to June 2019, 10762 units of blood and blood product were issued to 6995 patients. Of the 10762 blood component units selected for the issue, 10,696 (99.94%) the unit were issued for the patient and 66 (0.6%) units were discarded.

Among the recipients, 61% (n = 4266) were male and 39% (n = 2729) were female. The rate of reaction was 7.5% in females and 5% in males.

The age range of patients with adverse reactions was 6 months to 90 years. The sex and age distribution of the patients and transfusion reaction are presented in [Table 1] and [Figure 1], respectively.
Table 1: Sex distribution of the patients

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Figure 1: Age distribution of patient and transfusion reaction

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The blood components issued to the daycare and implicated transfusion reactions are demonstrated in [Table 2]. The most used blood component in daycare unit was packed red blood cells (54%) followed by fresh-frozen plasma (FFP) (24.5%) and platelet concentrate (21%). Among the packed red blood cell (PRBC) transfused, reaction occurred in 4.34% (n = 250) cases. Transfusion reaction also observed in 18% (n = 4) of whole blood, 6.88% (n = 157) of the platelet concentrate and 1.8% (n = 48) of the FFP transfused to patients.
Table 2: Transfusion reactions with different blood components

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Clinical conditions leading to transfusion in daycare unit are presented in [Figure 2]. Thalassemia is the most treated condition (57%) in daycare unit followed by hemophilia (17%). About 85% (390 out of 459) of patients received the previous transfusion.
Figure 2: Clinical conditions needing transfusion

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Transfusion reactions were classified into acute and delayed based on the onset of symptoms. Different types of transfusion reactions that manifested in our daycare patients are shown in [Table 3]. Acute transfusion reactions comprised of 85% (n = 390) of the total transfusion reactions and the remaining 15% (n = 69) was delayed type.
Table 3: Transfusion reaction in the patient associated with different blood components

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Acute hemolytic transfusion reaction (AHTR) was observed in 7 patients. Among them 2 were male and 5 were female. Two patients developed back pain, with hematuria within hours of transfusion and the remaining five patients developed fever during transfusion and hematuria 6-12 h following transfusion. One patient was wrongly grouped as 'B” Rh'D' positive instead of “A2B” Rh'D' Positive and transfused with “B” Rh'D' positive whole blood. Six patients who were transfused PRBC were found later to have alloantibodies (anti-E in four, Anti-E and Anti-c in one, and Anti-c in one patient). All the patients were positive for the direct antiglobulin test and recovered eventually with conservative management.

The mild allergic reaction was the most commonly observed transfusion reaction (40.5%, n = 186). Among the 186 cases, PRBC, platelet concentrate and FFP responsible for 61 (32.7%), 85 (45.7%), 40 (21.5%) cases, respectively. Symptoms associated with allergic reaction were pruritus (48%), rash (21%), urticaria (12%), pruritus, and rash (19%).

Severe allergic reaction (anaphylaxis) was noticed in three patients. Implicated units were platelet concentrate in two and FFP in one case. All patients were male and the clinical diagnosis of these two patients was Aplastic anemia and ALL and had a history of the previous transfusion.

Febrile nonhemolytic transfusion reaction was the second-most common transfusion reaction observed. Majority (67%) of patients had history of previous transfusion. Implicated unit were PRBC in 57.5% (n = 96) platelet concentrate in 40% (n = 67), FFP in 1,8% (n = 3) cases.

Two patients were reported to have circulatory overload due to transfusion. One patient who was 8 years old and was diagnosed with thalassemia transfused with whole blood developed shortness of breath 2 h after completion of transfusion. Another patient who was 14 years old developed circulatory overload as a result of apheresis platelet transfusion.

Transfusion-related acute lung injury was suspected intwo patients presented with shortness of breath and hypoxia within 3 h of transfusion. Both patients had radiological findings consisted of pulmonary edema. Implicated units were PRBC in all cases.

Transfusion-associated sepsis was suspected in two patients and the implicated units was PRBC. Both patients were diagnosed previously with thalassemia. Presenting features were fever (40°C) more than 2 days following transfusion, tachycardia, tachypnea, delayed capillary refill time with high leukocyte count. Blood culture of the implicated units and patient samples revealed no growth.

Fifteen patients were reported to experienced nausea and 6 patients were reported to have palpitation and tachycardia following transfusion. Most of the implicated units were PRBC (18 out of 21 units). As there were no other symptoms or signs, these reactions were tagged under unspecified.

Of total transfusion reactions 15% (n = 69) were delayed type. Among them delayed hemolytic transfusion reaction were 27.5% (n = 19), red cell alloimmunization were 62.3% (n = 43) and post transfusion hepatitis were 10.1%.

During the study period, a total of 87 laboratory and pretransfusion errors could be identified. An “error” was any deflection from the departmental standard operating procedure. The most commonly encountered error was incomplete blood requisition and order for wrong component (47%) which is 0.58% of total blood and blood component requisition. Other causes are listed in [Table 4].
Table 4: Errors in the transfusion chain

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  Discussion Top


The objective of this study was to find out the incidence of transfusion reactions and their causative factors in the blood transfusion recipients of our daycare unit and to identify the various errors in the transfusion chain.

In the present study, we found that out of the 10,696 components transfused to 6995 patients, a total of 459 (4.29%) transfusion reactions were observed. The incidence rate of transfusion reaction was 65.6/1000 people year and 43/1000 blood components per year which is much higher than the reported incidence rate in our neighbor country India (0.83 per 1000 blood components).[2. The reason may be because our daycare patients could be observed more closely for any transfusion reaction. Furthermore, 85% of the patients who received the previous transfusion may be a contributing factor. Sahu et al. showed that the true incidence of acute transfusion reaction is higher when active surveillance is carried out.[3] Gelaw et al. described a higher rate of transfusion reaction in the previously transfused patient compared to patients who never transfused before.[4]

The rate of acute transfusion reaction varies in different countries and centers as reported in India (0.19%–0.42%)[5],[6] Pakistan (0.15%),[7] Iran 0.94%[8] Taiwan (3.5%)[9] Nigeria (8.7%)[10] etc. The widely varying rates and percentage of transfusion reaction reported by different authors were probably due to the difference in participants and methodology of these studies. In our study, acute transfusion reactions were observed in 3.6% (n = 390) cases out of 10696 transfused blood components which are similar to the findings reported by Baffa A Gwaram et al.[11] and Goyal et al.[12]

In our setting transfusion reactions observed in male recipients (7.5%) were slightly higher than female recipients (5%). This finding is similar to other studies in southeast Asia.[13],[14] Contrary to this, some authors reported a higher transfusion reaction rate in female recipients than male recipients.[15] Regarding age distribution, most transfusion reactions were observed in the 20–29 years age group which is similar to the observation by Khoyumthem et al.

Overall, most common transfusion reactions observed in our setting were mild allergic reaction (40.5%, n = 186) and Febrile nonhemolytic transfusion reaction (36.4%, n = 167). This is similar to the findings reported by and Bhattacharya et al. and Vasudev et al.[16]

AHTR was 1.5% of the total transfusion reaction observed. Khoymthem et al. reported HTR as 3.57% of total transfusion reaction whereas Gente et al. reported it to be 5.83%.[17] In our setting most cases (6 out of 7) were due to alloantibodies in regular transfused thalassemia patients and PRBC was the implicated component. Both antibody screening in the recipient and antiglobulin crossmatch is not a routine practice in Bangladesh.[18] Grouping for minor antigens and Rh phenotype matched transfusion for multiple transfusion patients is not common here. These facts may result in alloantibodies formation and delayed hemolytic transfusion reaction and in some cases AHTR in multitransfused patients. Ayesha et al. described the presence of alloantibody in 25.97% of cases of multiple transfused thalassemia patients in this region.[19]

Majority of the patients in our daycare unit were thalassemia patients (57%). Hence, red blood cell components comprised more than half (54%) of the issued unit and also majority of the transfusion reactions observed with red cell transfusion (54.5%). Although the number of issued FFPs was higher than platelet concentrates, a higher reaction observed with transfusion of the later component (34.2% in platelet compared to 10.4% in FFP transfusion). This finding is similar to a study conducted by Prakash et al.[20] where majority of the reactions (78.8% were due to PRBCs followed by platelet concentration (16.7%) and FFP (4.5%). Khalid et al. reported similar findings.[21]

Posttransfusion hepatitis (1.5% of total transfusion reaction) was another delayed hazard observed in our study. All the cases were found when screening (HBsAg, Anti HCV, Anti HIV) tests were carried out for the patients who usually get transfusion in other centers. Positive screening tests were confirmed by ELISA which revealed that six patients were infected with HBV and one patient was infected with Hepatitis C Virus. Shekhar et al. found 19% and 2.4% of multitransfused thalassemia patient was seropositive for HBsAg and Anti-HCV, respectively[22] Jung et al. describe seropositivity of HBsAg and Anti-HCV of 6.4% and 45.7%, respectively, in 140 transfusion-dependent thalassemia and hemophilia patient.[23]

In the study period, a total of 87 laboratory errors were identified. The most encountered error was incomplete blood requisition and order for wrong component (47%, n = 41) which is higher than 30.5% reported by Sidhu et al.[24] Among these errors, failure to mention previous transfusion history and obstetric history of the patient, wrong number of components required, the proper name of blood component, failure to mention the intended date of transfusion were frequently encountered. In our setting the requisition error comprised 0.58%. Jain et al. reported requisition error of 2.76%.[25] Wrong blood in the tube (20% of pretransfusion error, n = 18) was a serious error which mostly detected during grouping and evaluation of the historical blood group. The frequency of wrong blood in the tube in our setting is 15% which is comparable to Jain et al.

Limitation of the study

Our study population was the patients attending transfusion medicine daycare unit which was only a fraction of the total patients receiving transfusion in the hospital. Moreover, as most of the patients in daycare required multiple transfusions, they were not representative of all hospital patients who required transfusion. We could not analyze the data of total blood component supplied by the blood bank as hemovigilance program was not being practiced in the hospital during the study period.


  Conclusion Top


This study was conducted as an effort toward institutional hemovigilance as we evaluated adverse events related to transfusion occurring in our department of transfusion medicine. We hope that this study will help not only to understand problems regarding transfusion in our setting but also to point out the necessity of implementing an effective hemovigilance program. Internal quality control and good teamwork are key and are undermined by insufficient staffing and poor morale. The concept of hemovigilance should be familiar to all staff of a health care facility and they should be trained and skilled enough for appropriate documentation and reporting.

Acknowledgment

The authors would like to thank the Department of Transfusion Medicine, Bangabandhu Sheikh Mujib Medical University, for concluding this study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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