Analysis of adverse transfusion reaction in a tertiary care hospital in South India: A retrospective study

INTRODUCTION

Blood transfusion is a life-saving medical intervention. With every blood component transfusion, there is a risk of acute or delayed transfusion reactions. There is also a risk of transfusion-transmitted infection for the recipient.^[1] Past few years, major developments have taken place in the field of blood transfusion service, like component separation, which reduces the usage of whole blood, the introduction of apheresis technology, and nucleic acid testing.^[2] Introduction of newer technology, however, does not alter the incidence of adverse events due to clerical errors. Risk of bacterial contamination, alloimmunization, and ABO incompatibility prevailed with every transfusion.^[3]

Adverse transfusion reactions (ATR) are untoward effects occurring in any patient during or after receiving blood or blood components. These reactions can be classified into acute transfusion reactions (occurring within 24 h) and delayed transfusion reactions (occurring within days to months of transfusion). Further, acute and delayed transfusion reactions can be divided into immune-mediated and non-immune-mediated.^[4] The incidence of acute transfusion reactions has been estimated to be between 0.2% and 10%. Among these, the fatal outcome is approximately one in 2,50,000 transfusions.^[5] The commonly faced transfusion reactions include febrile non-hemolytic transfusion reaction (FNHTR), allergic transfusion reaction (ALTR), hemolytic transfusion reaction (HTR), transfusion-related acute lung injury (TRALI), transfusion-associated cardiac overload (TACO), and transfusion-associated sepsis (TAS).

There are some gaps in India’s transfusion reaction reporting. These under-reporting, non-reporting data significantly undermine national blood safety efforts. The true incidence of ATRs remains largely unknown due to widespread underreporting, inconsistencies in data collection, and systemic barriers that prevent a robust surveillance system. This informational deficit compromises patient safety, impedes trend analysis, and hinders the implementation of effective, evidence-based preventive measures.

While some urban medical centers have reported data on ATRs, many facilities, especially in resource-constrained rural and semi-urban areas, fail to participate effectively in the hemovigilance program India (HvPI). This creates a disjointed national picture, with disparities in reporting rates, data quality, and the ability to identify specific risks. Addressing these deficiencies is critical for strengthening the national hemovigilance system, enhancing transfusion practices, and ensuring comprehensive blood safety for all patients across India.

Hemovigilance is defined as a set of surveillance procedures of the whole transfusion chain intended to minimize adverse events or reactions in donors and recipients and to promote safe and effective use of blood components.^[6] The hemovigilance program was first launched in France in 1994. Several other countries followed.^[7] In India, this program was launched in the year 2012. Still, there is a lack of proper and strict hemovigilance systems in our country, which makes it difficult to find the actual incidence of transfusion reactions. The present study aims to estimate the incidence of various reactions and to analyze transfusion-related adverse reactions.

MATERIAL AND METHODS

The present study was conducted in the Department of Transfusion Medicine at a tertiary healthcare center in Southern India. All the data were collected retrospectively from departmental records. Records of all the events were reviewed from August 2020 to January 2022. All the adverse events were arranged in tabulated form and analyzed.

This was a retrospective observational study. All the alleged cases of transfusion reaction were included in the study. Whenever any transfusion reaction was reported, a doctor from the blood center used to visit the patient. Depending on the history of reaction (acute, chronic), nature of sign symptoms (urticarial, hives, fever, dyspnea, pain, etc.), clinical findings (blood pressure, pulse, temperature, SpO₂, respiratory rate), a provisional diagnosis was made. Then patients were asked for some basic laboratory tests, i.e., complete blood count, liver function test, renal function test, lactate dehydrogenase, urine examination, chest X-ray, etc. Pre-transfusion sample and post-transfusion sample of the patient were analyzed to look for clerical error, technical error, or the possibility of hemolytic transfusion reactions. All the workup was done in accordance with the American Association of Blood Banks technical manual.^[3] All the reactions are classified as per their clinical presentation, supported by laboratory investigations.

RESULTS

A total of 66,221 blood components were issued to various wards, operating theaters, and emergencies. These include packed red blood cells 24219 (36.57%), fresh frozen plasma 20400 (30.8%), and platelets 19726 (29.7%) [Table 1]. Incidence of acute transfusion reactions was found to be 0.13% (total 84 reactions out of 66,221 units transfused). Gender-wise and sex-wise distribution of reactions is shown in Table 2.

The type of transfusion reactions with the blood component transfused has been described in Table 1. Figure 1 shows the relation of transfusion with blood group and various symptoms of transfusion reactions.

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Figure 1:

Symptoms of adverse transfusion reactions.

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The most common type of transfusion reaction was found to be FNHTR (38%, 32 out of 84 reported cases). FNHTR was seen in patients transfused after packed red blood cell concentrate (PRBC) 47% (30/64). About 75% of FNHTR patients had fever as presenting symptoms, while about 69% complained of chills and rigor. Allergic reactions were the second most commonly encountered acute reaction, i.e., 33% (28/84). PRBC was implicated in 18% (12/64), followed by fresh frozen plasma (FFP) in 100% (7/7) [Table 1]. In almost all patients with allergic reactions, the presenting symptoms were urticaria and itching. Anaphylactic reactions were seen in only 12% (10/84), out of which 7 were due to PRBC transfusion and 1 due to single donor platelet (SDP) and 2 due to random donor platelet (RDP) transfusion [Table 1]. Clinical signs and symptoms in most cases are breathlessness, hypotension, rash, periorbital edema, and angioedema, noted in 2 cases; both patients recovered without any sequelae.

TACO comprised 2% of acute transfusion reaction cases. TACO was reported in patients on two patients who received multiple transfusions. Both patients were at extreme age and with cardiac dysfunction. TRALI was reported in 1.1% ATR cases. RDP was associated with all TRALI cases [Table 2]. The patient had breathlessness, SpO₂ dropped to 45%, intubated and ventilated. Another patient had acute hemolytic reaction due to transfusion of frozen PRBC. This patient complained chills and rigor, followed by hematuria.

DISCUSSION

Despite rigorous safety protocols, the inherent nature of blood transfusion as an allogeneic (non-self) tissue transplant means that risks can never be fully eliminated. The most serious, though now rare, reactions include acute HTRs (AHTR) due to ABO incompatibility and TRALI. AHTR is a sentinel event, almost always caused by human error in patient identification or sample collection, underscoring that the “safest” transfusion is the one prevented by careful patient blood management. TRALI, once a leading cause of transfusion-related fatality. The present study has a minimum HTR and TRALI may be due to risk reduction strategies, including various checks to prevent human errors and avoiding the use of plasma from male donors or donors with a negative history of pregnancy.

Identification of transfusion reaction and management are important aspects of blood safety. As per the 2001 report of a Hemovigilance system of the Canadian province of Quebec, the incidence of transfusion reaction was 0.35% for various blood components.^[8] Incidence in our center was found to be 0.13% which is similar to previous studies. In a similar study done by Gente et al.,^[9] the prevalence of transfusion reactions was found to be 0.15%, and Chakravarty-Vartak et al. reported 0.16%.^[10] Similarly, Mukherjee et al.,^[11] Sidhu et al.,^[12] and Kumar et al.,^[13] and Sahoo et al.^[14] found a rate of 0.30%, 0.28% and 0.05%, 0.16% respectively.

Underreporting of the actual number of transfusion reactions may also occur. Underreporting of transfusion reactions is a significant and persistent problem in healthcare, making it difficult to determine the true incidence of adverse events and compromising patient safety. The failure to report adverse events, particularly minor ones, can hinder a hospital’s hemovigilance program, prevent critical quality improvements, and put future patients at risk. Studies that use active surveillance, instead of relying on voluntary reporting, consistently find higher rates of adverse reactions, highlighting the scale of the underreporting issue. Unused blood products should be returned to the blood center. Blood products not returned or the blood completion form not sent back to the blood center may be the causes of under-reporting of these transfusion reactions. Narvios et al reported differences in rates of prevalence due to underreporting in their studies.^[15] Data from different studies vary due to differences in reporting reactions, use of premedication before transfusion, multiple transfusions, and efficiency of staff monitoring the reaction. Anaphylactic reactions were seen in 0.028% with PRBC, 0.01% with RDP transfusions. They differ from other allergic reactions by their systemic nature and severity. Anaphylactoid reactions are acute hypersensitivity reactions clinically similar to anaphylaxis.

Identification of the correct type of transfusion reaction and reporting to the blood center should be a regular practice. Monitoring during transfusion is a must to avoid any severe reactions. Awareness among the medical fraternity regarding blood components usage and risk, appropriate use of blood components, and implementation of various educational programs for rational use of blood can enhance the safety of transfusions. In summary, while transfusion reactions cannot be eliminated, their frequency and severity can be minimized through vigilant clinical practice, robust laboratory screening, and continuous monitoring. Understanding the pathophysiology and presentation of various transfusion reactions allows for timely intervention, thereby improving transfusion safety and patient outcomes.

CONCLUSION

Our study has shown a lower incidence of transfusion reactions. Proper identification of transfusion reactions, reporting to the blood center for further workup up is a key for better patient care.