|Year : 2017 | Volume
| Issue : 2 | Page : 124-129
Recipient hemovigilance study in a university teaching hospital of South India: An institutional report for the year 2014–2015
Pallavi Prakash, Vijaya Basavaraj, Rashmi B Kumar
Department of Transfusion Medicine, JSS Medical College and Hospital, JSS University, Mysuru, Karnataka, India
|Date of Web Publication||11-Sep-2017|
Department of Transfusion Medicine, JSS Medical College and Hospital, JSS University, Mysuru, Karnataka
Source of Support: None, Conflict of Interest: None
Background and Aim: Blood transfusion plays an important role in improving the health and saves lives. However, it is a double-edged sword, which should be used judiciously as it is also inherently embedded with adverse reactions ranging in severity from minor to life threatening events. Haemovigilance programme of India (HvPI) aims to ensure the transfusion safety by monitoring every step of transfusion process from donor to recipient. Recipient hemovigilance is reporting of adverse transfusion reactions (ATRs) in the patient. Contributing to this program as registered member, this study aimed to determine the frequency and type of ATRs in blood recipients. Materials and Methods: The study was conducted in the Department of Transfusion Medicine of a University Teaching Hospital of South India. This was a retrospective, observational study in which all ATRs reported by the department to HvPI observed in patients admitted in various clinical departments over a period of 24 months (January 2014 to December 2015) were reviewed and analyzed. Results: During the study, a total of 31,687 blood and blood components were issued, out of which a total of 66 (0.2%) ATRs were reported. The most common type of reaction observed was febrile nonhemolytic transfusion reaction (FNHTR) 54.55% (n = 36), followed by allergic 33.33% (n = 22). The other reactions observed were nonspecific reactions 9.09% (n = 6), acute hemolytic reaction 1.52% (n = 1), and mixed type reaction of FNHTR and allergic reaction in 1.52% (n = 1). No case of transfusion-related acute lung injury, transfusion-associated circulatory overload, anaphylaxis, and transfusion-related sepsis was reported. The ATRs were seen mostly with packed red blood cells (78.8%). Conclusion: The frequency of ATR in our institution was 0.2%. Febrile and allergic reactions were the most common type.
Keywords: Adverse transfusion reaction, blood safety, recipient hemovigilance
|How to cite this article:|
Prakash P, Basavaraj V, Kumar RB. Recipient hemovigilance study in a university teaching hospital of South India: An institutional report for the year 2014–2015. Glob J Transfus Med 2017;2:124-9
|How to cite this URL:|
Prakash P, Basavaraj V, Kumar RB. Recipient hemovigilance study in a university teaching hospital of South India: An institutional report for the year 2014–2015. Glob J Transfus Med [serial online] 2017 [cited 2021 Jun 25];2:124-9. Available from: https://www.gjtmonline.com/text.asp?2017/2/2/124/214291
| Introduction|| |
Blood transfusion is a life-saving procedure having many clinical benefits. However, it is a double-edged sword, which should be used judiciously as it is also inherently embedded with adverse reactions ranging in severity from minor to life-threatening. Hence, every transfusion should be carefully monitored for adverse reactions. Continuous monitoring of transfusion-related complications can promote understanding of factors contributing to transfusion reactions and help to formulate necessary remedial measures. In addition, continuous monitoring of transfusion-related complications can promote patient care and safety.
An adverse transfusion reaction (ATR) is an unfavorable reaction to the transfused blood unit, the severity of which may be different among individuals depending on the type of reaction and the patient's susceptibility. Transfusion reactions may be immediate or delayed type depending on the onset and immune or nonimmune type depending on the pathogenesis. Acute reactions occur within minutes to 24 h of the transfusion. Acute reactions are cell and plasma-related and are immediate hemolytic transfusion reaction, febrile nonhemolytic transfusion reaction (FNHTR), urticarial, anaphylactic, transfusion-related acute lung injury (TRALI), transfusion-related sepsis, transfusion-associated circulatory overload (TACO), nonhemolytic hemolysis, air embolism and hypothermia. Delayed reactions usually occur after 24 h. Delayed reactions are due to secondary anamnestic response, and these are delayed hemolytic transfusion reaction, alloimmunization against red blood cell (RBC) and human leukocyte antigens, graft versus host disease, post transfusion purpura, immunomodulation and iron overload.
Recipient hemovigilance is reporting of ATRs in the patient. Hemovigilance is a continuous process of data collection and analysis of blood transfusion-related adverse reaction to investigate their causes and outcomes and prevent their occurrence or recurrence. A centralized Haemovigilance Programme was launched in India on December 10, 2012 to assure the patient safety and promote public health through a well-structured program for monitoring of adverse reactions associated with blood and blood product transfusion. The National Institute of Biologicals, NOIDA is the National Coordinating Centre. The Haemovigilance Programme of India (HvPI) was started under the broad ambit of Pharmacovigilance Programme of India. The goal of hemovigilance is to increase the safety and quality of blood transfusion. Hemovigilance aims to monitor transfusion reactions, create awareness among health-care professionals, generate evidence-based recommendations, advice central drugs standard control organization for safety-related regulatory decisions, communicate finding to all the key stakeholders, and create national and international linkages. Our institution obtained affiliation to the HvPI in 2013, and since then, we are reporting all ATRs.
It is important to identify various ATRs so that steps can be taken to minimize such reactions and add safety to the blood transfusion being carried out. Hence, this study was carried out with the objective of reviewing and analyzing the ATRs reported by the Department of Transfusion Medicine of a university teaching hospital to HvPI.
| Materials and Methods|| |
The study was conducted in the Department of Transfusion Medicine of a University teaching hospital of South India. This was a retrospective, observational study in which all ATRs observed among patients admitted in various clinical departments over a period of 24 months (January 2014 to December 2015) were reviewed and analyzed. All ATRs were reported to HvPI by the Transfusion Medicine department. Approval for conducting the study was obtained from the Institutional Ethical Committee.
An ATR was considered as the adverse response in the patient associated with administration of blood or blood components. As per our institutional standard operating procedure (SOP), consent for blood transfusion was obtained by patients or their attenders before every transfusion episode. As per the SOP for blood issue, every unit of blood component was issued along with a transfusion reaction/evaluation form to record the details of transfusion including patient details, component details, date and time of transfusion, vital parameters, and record of transfusion reaction if any. If the transfusion procedure was uneventful, the transfusion form had to be completely filled providing the date and time of starting and completion of the transfusion, patient's pre and post-transfusion vital signs, and returned to the blood bank with the empty blood bag. This helped us to trace the fate of every blood unit. In case of ATR, the form had to be completely filled with details of reaction (time of onset of reaction) and sent to blood bank along with the left over blood product bag with the attached transfusion set and patient post-reaction blood samples – ethylenediaminetetraacetic acid (EDTA) and plain vacutainer. These cases were worked up by the transfusion medicine physician according to a standard protocol. The requisition form, patient's blood sample, and the component bag were cross-checked to rule out clerical errors. The period between the issue of blood component and the start of transfusion was noted, and in case of delay, the storage conditions of the product were inquired. The blood bag and the transfusion set were examined for any clot or discoloration. Plasma in the post reaction blood sample was inspected for evidence of hemolysis. ABO-Rh blood group, repeat cross match, and direct antiglobulin test (DAT) was performed on patients pre- and post-reaction samples and on sample from blood bag. Peripheral blood film of post-reaction sample and patient's urine were checked for the evidence of hemolysis. Blood bag, transfusion set and the patient's blood sample were sent for culture. Bacterial sepsis was confirmed if the blood culture of the patient and the transfused component contained the same organism and had the same pattern of antibiotic sensitivity, i.e., same antibiogram. In case of a reaction presenting with fever and dyspnea, chest X-ray was performed to rule out TRALI. The signs and symptoms for which the evidence for reaction was indeterminate were classified as nonspecific reactions. The reactions were graded as per ISBT criteria and guidelines given by the HvPI [Table 1]. The imputability levels were given as per the ISBT criteria and guidelines given by the HvPI [Table 2]. Imputability/causality assessment means the likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component. Details of all ATRs over a period of 2 years were collected and analyzed. The denominators for the ATRs were the total number of units issued which was retrieved from the blood bank records.
|Table 2: International Society of Blood Transfusion criteria for imputability as followed by haemovigilance programme of India|
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Statistical analysis: The analysis was done using percentages. Z test for single proportion was applied to assess the significance of ADRs and the results were interpreted statistically significant at P< 0.05.
| Results|| |
During the study, a total of 31,687 blood and blood components were issued from the department. The total number of ATRs reported from transfusion of various blood and blood components during this period was 66 (0.2%) [Table 3]. The age range of the patients with adverse reactions was 2–73 years. Out of 66 patients who had ATR, 32 were male, and 34 were female. All the 66 reactions in the present study were of immediate/acute type occurring within 24 h of blood transfusion. ATR were graded as per ISBT criteria [Table 1] and all reactions were of Grade 1, nonsevere type. All patients recovered with no mortality due to ATR. First time transfusion was reported in 45 reactions (68.18%) and 21 reactions (32.82%) were seen in previously transfused patients. In majority of reactions (52 cases), the imputability level was assessed as definite (certain). In eight cases, the imputability was assessed as probable (likely) and six cases as possible.
|Table 3: Number of transfusions and transfusion reactions reported with various blood components|
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Among 66 ATRs reported, 52 (78.8%) reactions were seen with packed RBCs, 11 (16.7%) and 3 (4.5%) reactions were seen with platelets and fresh frozen plasma, respectively [Table 3]. The incidence of ATRs with packed RBC, platelets and fresh frozen plasma were statistically significant (P< 0.05). Fever (≥1°C increase) and chills/rigors were present in 42.42% and 34.85% of the symptomatic cases, respectively [Table 4]. The incidence of clinical signs and symptoms related to allergic reactions (hives 22.73% and itching 12.12%) were 34.85% [Table 4]. The other symptoms reported in our study were nausea/vomiting (6.06%), dyspnea (6.06%), palpitation (3.03%) and pain (3.03%). Headache, giddiness, and generalized weakness were seen only in 1.52% of cases each [Table 4].
All the ATRs were evaluated by the blood bank physician. ATR workup of the cases did not reveal clerical or technical error in any of the cases. Physical examination revealed hemolysis in posttransfusion sample in one case. There was no discrepancy between pre-transfusion and post-transfusion samples in blood grouping or cross-matching. None of the culture reports of blood sample from bag and patient showed growth of any kind of organism. Indirect Coomb's test was positive in one case (1.52%), and direct Coomb's test was positive in one case (1.52%). All the reported ATRs were classified according to investigations and the established criteria. The spectrum of adverse reactions noted with different blood components is shown in [Table 5].
|Table 5: Distribution of adverse transfusion reaction according to the type of the blood component|
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The result of the workup was correlated with clinical findings, and the final impression was given. It was found that the FNHTRs was the most common reaction seen in 36 (54.55%) cases followed by allergic reactions in 22 (33.33%) and nonspecific reactions in six (9.09%) cases. Acute hemolytic reaction was observed in one patient (1.52%) and mixed type having both FNHTR and allergic reaction was noted in one patient (1.52%). No case of TRALI, TACO, anaphylaxis and transfusion-related sepsis was reported.
| Discussion|| |
Each blood product transfused carries a small risk of an adverse effect. The reported incidence of ATRs in the literature varied widely from 0.5% to 3% of all transfusion episodes. In our study, the frequency of ATRs was observed to be 0.2% [Table 3], which is comparable to that of a study carried out in Chandigarh by Bhattacharya et al., where the incidence of ATRs was 0.18%. Similarly, lower incidence of 0.05% was reported in a study conducted in New Delhi by Kumar et al. However, two studies done in teaching hospital of Sikkim and Punjab showed a relatively higher frequency of transfusion reactions (0.92% and 1.09%, respectively)., A study in Switzerland and the Quebec hemovigilance system reported transfusion reaction rates of 0.042% and 0.035%, respectively.
The incidence of ATR in the present study observed no significant sex predilection reporting 48.48% in males and 51.51% in females. A similarly skewed incidence of transfusion reactions in female (54.3%) was seen in study done in a tertiary care hospital of Uttarakhand by Negi et al. High incidence of ATR in female (59.4%) was noted in study done in Sikkim by Sharma et al. However, studies done in Chandigarh by Bhattacharya et al. and in Delhi by Kumar et al. showed a lower incidence of transfusion reactions in females (34.2% and 45.7%, respectively).,
Majority of the reactions (78.8%) were due to packed RBCs transfusion followed by platelet concentrates and FFP transfusions with the rates of 16.7% and 4.5%, respectively [Table 3]. Similar reaction rates of 87.7%, 7.0%, 5.1% for red cells, platelets transfusion and FFP respectively were observed by Khalid et al. A study done by Negi et al. at blood bank of a tertiary care center of Northern India showed that 92% of reactions were due to whole blood and packed RBC transfusion followed by FFP and platelet concentrates transfusions with the rates of 3.9% and 5.9%, respectively. However, Payandeh et al. recorded the reaction rates to be 45.7%, 30.5%, and 20.3% for RBCs, platelets, and fresh frozen plasma, respectively.
The incidence of various ATRs in our study was FNHTRs 36 (54.55%), allergic reactions 22 (33.33%), nonspecific reactions 6 (9.09%), and hemolytic (1.52%) [Table 5]. Khalid et al. also recorded similar results with 41.9% of FNHTR, 34.4% allergic reactions, 1.8% hemolytic, and 5.1% nonspecific reactions. A study conducted by Chowdary et al. showed 62% of FNHTR, 25% allergic reactions, and 12.5% TRALI. Similarly, Bhattacharya et al. observed 41% of FNHTR and 34% allergic reactions. The incidence of various types of ATRs vary according to pathophysiology, symptoms, and severity. Therefore, a comprehensive approach is required on part of the attending physician so that ATR can be assumed once other differential diagnosis have been ruled out.
Febrile reactions usually occur in about 1% of transfusions. It is defined as a 1°C temperature rise associated with transfusion and having no medical explanation other than blood/component transfusion. Rigors and other symptoms in the absence of fever are also included as FNHTR. In this study, FNHTR was observed in 36 (54.55%) patients [Table 5]. Fever as presenting symptoms was seen in 28 patients, followed by chills and rigor in 23 patients [Table 4]. Associated symptoms such as vomiting, generalized weakness, and headache were also noted. Bhattacharya et al. found FNHTR in 41% of cases and fever, chills, and rigors were the main presenting symptoms. In the present study, it was observed that fever usually came at the end of transfusion with or without chills and not exceeded 101°F. All patients with FNHTR were managed by administration of paracetamol.
In this study, FNHTRs were found to be more with PRBC transfusion (0.19% of all PRBC transfusions) than platelets (0.04%) and FFP (0.03%) transfusion. The risk of FNHTR with transfusion of non-leukoreduced whole blood and PRBCs was estimated to be 0.114% in a study done in Chandigarh by Bhattacharya et al., which is closer to the incidence of FNHTRs seen in this study. In a study done at AIIMS by Kumar et al., the frequency of FNHTRs with PRBCs was found to be 0.04%, which was lower than that observed in this study. The higher rate of FNHTRs in our study could be due to lack of leukoreduction facility at our hospital. A comparative study on incidence of FNHTR in leukoreduced and nonleukoreduced blood components showed that the incidence is 0.12% in nonleukoreduced and 0.08% in prestorage leukoreduced blood. Hence, introduction of leukoreduction at our institution could possibly enable us to reduce the febrile reactions.
In the present study, allergic type of ATR was observed in 33.33% of patients with reactions. They presented most commonly with urticaria and/or itching. All reactions were of mild type and were treated by simple chlorpheniramine. No anaphylactic reaction or severe reaction occurred. Allergic reactions can occur in up to 2% of transfusions as a result of recipient IgE and donor antigen interactions triggering the release of histamine and de novo synthesis of leukotrienes and platelet activating factor. Allergic reactions in the present study were seen in 0.09% of total PRBC units transfused, 0.01% of FFP, and 0.10% of platelet concentrate transfusions [Table 5]. Similarly, Kumar et al. noted allergic reactions in 0.05% of total PRBC transfused and 0.006% of platelet concentrate transfusions. In contrast, Bhattacharya et al. noted higher incidence of 0.87%, 2.45%, and 0.47% with PRBC, platelets and FFP transfusion, respectively. Treatment of allergic transfusion reactions with antihistamines is usually adequate and transfusion can be resumed once symptoms have dissipated. This is the only type of transfusion reaction where the component may continue to be administered following prompt treatment. In patients with prior allergic reactions to transfusions, premedication with antihistamines 30 min before transfusion may be beneficial.
Acute hemolytic reaction was observed in one patient (1.52%) [Table 5] in a female aged 6 years diagnosed as autoimmune hemolytic anemia. Her pre-transfusion hemoglobin was 5% gm. One unit of best compatible PRBC unit was issued with special instructions to monitor the patient for hemolytic transfusion reactions. The patient presented with dark-colored urine after completion of transfusion and hemoglobinuria was confirmed. DAT was positive in both pretransfusion and post transfusion blood sample. The patient was symptomatically treated. Mixed type reaction with features of both FNHTR and allergic reaction was noted in one patient (1.52%) [Table 5] with platelet transfusion. No case of TRALI, TACO, anaphylaxis, and transfusion related sepsis was reported.
Transfusion is a multistep process in which the members of different profession mainly doctors, nurses, laboratory technologists, and also the donors and recipients of transfusion participate. To ensure safety at bedside in our institution, blood transfusion registers are maintained at every ward. Regular awareness program among the nursing staff about handling and storage of blood and components has been developed by the department. Due to this awareness, there was no ATR due to improper storage conditions. Patient safety also requires knowledgeable monitoring by nurses during transfusion.
Among 66 reactions, ATR workup did not reveal a clerical error in any of the cases. This could be attributed to our institutional policy of checking the patient blood group report and unique patient register number at multiple levels by the technician, doctor, person issuing the blood unit, and finally by the nursing staff, and the doctor responsible for blood administration. Similarly, no ATR was noted due to clerical error in a study done in Uttarakhand. As per our institutional policy, blood samples for blood grouping and cross-matching are separately collected. The vacutainers are labeled soon after collection at patient bedside. In addition, positive patient identification is done using wristbands that display 2 independent identifiers (full name and hospital register number). This policy prevented wrong blood in the tube. Hospital transfusion committee plays a very important role in setting down policies and protocols and promoting safety, efficacy, and efficiency of blood transfusion services. HTC acts as a bridge between blood services and clinical services.
Blood transfusion plays an important role in improving the health and saves lives. Hemovigilance system is an important program which ensures the transfusion safety. Haemovigilance monitors every step of transfusion process from donor to recipient (from vein to vein). It covers the whole chain of transfusion with various objects such as monitoring of prevalence and incidence of infectious markers in blood donors, compiling the data of adverse reactions/events including transfusion errors, and product-related side effects either suspected or confirmed and providing alert/warning procedures, thereby covering the whole transfusion chain and the respective activities.
| Conclusion|| |
The incidence of ATR in our study was 0.2% and majority of the reactions were seen with packed RBC transfusions. Febrile nonhemolytic transfusion and allergic reactions were the most common type. The present institutional hemovigilance data is highly valuable as it facilitates corrective and preventive actions to minimize the potential risks associated with safety and quality in blood processing and transfusion to donors, patients, and staff. Such information is also important for introducing required changes in the applicable policies, improving the standards, systems and processes, formulation of guidelines as well as increasing the safety and quality of the entire process from donation to transfusion.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]