Lifelines at risk: A mixed-methods study on transfusion reactions and patient outcomes in Puducherry

INTRODUCTION

A strong health care delivery system roots from readily accessible blood transfusion facilities as an integral part. Blood transfusion is an effective method for correcting patients’ hematological deficiencies or needs.^[1] The inherent risk associated with it is the various types of transfusion reactions (TRs) which can happen during or after transfusion. These adverse events associated with the transfusion of whole blood or one of its components are known as TRs. The TRs can be broadly classified as (i) acute or delayed (depending upon the time of occurrence) and (ii) immune or non-immune (depending upon the pathophysiology).^[2] It has been estimated that up to 10% of all blood transfusions are associated with an adverse event. Judicious donor screening and strict transfusion transmissible diseases testing procedures have led to a decrease in the hazards and risks that are associated with the transmission of the infectious diseases associated with blood transfusion. The primary objective of the hemovigilance program in India, launched in 2012, was to observe, identify, and prevent the occurrence or recurrence of transfusion-related adverse events to increase the safety, efficacy, and efficiency of the blood transfusion process, covering the entire blood transfusion chain from donors to recipients. The process of the hemovigilance program depends on the reporting of TRs by clinicians to the transfusion services that upload the data on the national portals.^[3-5]

With this background, the objective of our study was to observe and analyze the TRs encountered in our blood bank. Henceforth, this workup will enable us to develop insight into patterns of TR registered in our institutions and this will help to design effective preventive measures in the future.

MATERIAL AND METHODS

RESULTS

The majority of the adverse TRs (ATRs) were fever with chills and rigor, fever, itching, and rashes. Reactions were encountered mostly among the females when compared to the males. Most of the reaction occurred due to concentrated red blood cells (CRCs) blood products and reaction occurred after 1–2 h from the start of transfusion.

Among the study participants, the majority nine were from age group of 61 to 70 years, eight were from age group of 21 to 30 years, seven were from age group of 41 to 50 years, five were from 51 to 60 years, four were from 31 to 40 years, and remaining two were from 71 to 80 years [Figure 1].

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Figure 1:

Age distribution of the study participants.

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[Figure 2] shows the gender distribution among the study participants; the majority 64% were females, and the remaining 36% were males.

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Figure 2:

Sex distribution of the study participants.

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[Table 1] shows the number of blood products issued during the study period, a total of 63 units of white blood cells, 1593 units of fresh frozen plasma (FFP), 2251 units of platelets (PLT), and 8806 of CRC were issued. The total number of transfusion done was 12,713 and number of ATRs was 39. ATRs were more during 2019 (13) and reduced were during 2022 (3). [Table 2] shows the various types of allergic reactions. Among the 39 participants, majority 13 had fever with chills and rigor, 5 had only fever, 3 had itching and rash, and two had only rash. Other participants had itching associated with tachycardia, dyspnea, periorbital edema, hypotension, bradycardia, etc. In ATRs, 25 females had reactions such as fever with chills and rigor, itching and rash, and other reactions such as hypotension, bradycardia, and tachycardia. Fourteen males had reactions such as fever, redness, chills, and rigor [Table 3].

[Figure 3] shows the distribution of ATR according to age, blood group, and diagnosis; the majority 15% had B positive, 11% had A positive, 7% had O positive, 4% had AB positive, and 1% had O negative group. Females had more ATRs compared to males. Among the study participants, the clinical diagnosis distribution was anemia, pancytopenia, healed patellar fracture, and dengue. Of all the diagnoses, females had the majority of diagnoses, such as anemia, and males had fewer diagnoses [Figure 4]. The duration between the start of transfusion and onset of TR were 1–2 h (among 11 participants), 2–3 h (for 8 participants), 1 h (for 7 participants), 30–60 min (4 participants), <30 min (4 participants), 3–4 h (3 participants), and >4 h (2 participants) [Figure 5].

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Figure 3:

Distribution of ATR according to age, blood group, and diagnosis.

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Figure 4:

Distribution of clinical diagnosis among study participants.

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Figure 5:

Time interval between the start of transfusion and onset of transfusion reaction.

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[Table 4], shows the TRs according to the blood component transfused, among the study participants, 34 reactions were due to CRC, 3 were due to PLT and 2 were due to FFP.

The barriers enlisted and graded in force field analysis are misidentification of patients, issuing wrong blood group, blood bank technical and storage errors, and improper cross matching and blood grouping. The facilitating factors are proper storage and transportation, aseptic collection and processing, avoid unnecessary transfusion, careful and close monitoring of the patient while transfusion and proper identification and collecting proper history of the patient [Figure 6]. Among the facilitating factors and barriers, avoiding unnecessary transfusion and wrong blood issued were more graded. The arrow marks are used to represent the strength and direction of different forces that influence a change or decision.

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Figure 6:

Force field analysis showing barriers and facilitating factors for adverse effects following transfusion reaction.

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DISCUSSION

The first hemovigilance surveillance system was implemented in 1994 in France as part of mandatory reporting under updated French regulations. The Serious Hazards of Transfusion (SHOT) initiative was established in the United Kingdom in 1996 as a voluntary reporting system.^[1] Through SHOT, 366 reports of deaths or major transfusion-related complications were documented, with the most common adverse event (52%) being the administration of incorrect blood to recipients. In India, the Indian Pharmacopoeia Commission, in collaboration with the National Institute of Biologicals, launched the Hemovigilance Programme of India on December 10^th, 2012. The main objectives of the program are to track adverse reactions and incidents associated with blood and blood product transfusions, identify trends, recommend best practices and interventions, and improve patient care and safety, thereby enhancing overall healthcare quality.^[2]

TRs present as adverse signs and symptoms occurring in patients during or after transfusion of blood components. These can be of the following types: (1) Immune reactions, (2) non-immune reactions, (3) immediate reactions (during or within few hours of transfusion), and (4) delayed reactions (days or weeks after the transfusion).^[3-5]

In our study, majority of the ATRs are acute in nature such as fever with chills and rigor, fever, itching, and rashes. Reactions were encountered mostly among the females when compared to the males. Most of the reaction occurred due to CRC blood products and reaction occurred after 1–2 h from the start of transfusion.

In the study conducted by Gotekar and Khade, the reported TRs were primarily acute in nature, with a frequency of 0.21% (77 out of 35,593 transfusions).^[9] Similarly, Bhattacharya et al. reported an incidence of 0.18% (105 reactions out of 56,503 units of blood and blood components transfused), and Pahuja et al.^[10,11] observed an incidence of 0.19% (314 out of 160,973 units transfused). In Gotekar and Khade’s study,^[9] females were more affected (47, 61.03%) compared to males (30, 38.96%), a finding consistent with studies by Sidhu et al. and Sharma et al., where females also had a higher frequency of acute TRs (59.4% vs. 40.6% in males).^[12,13] However, Kumar et al. ^[14] reported a higher incidence in males. In our study, all TRs were of the acute type, and females were more affected, aligning with the findings of Gotekar and Khade and other similar studies.^[9]

The study conducted by Sharma et al. found that the most common acute TR (ATR) was an allergic reaction, accounting for 65.6% of all ATRs, most frequently presenting with urticaria and/or itching. In our study, the common manifestations of acute TRs included fever, chills, itching, and rashes.^[15]

Allergic reactions can occur in up to 2% of transfusions as a result of recipient immunoglobulin and donor antigen interactions, triggering the release of histamine and de novo synthesis of leukotrienes and PLT-activating factor.^[16] Clinically, allergic reactions have been discerned from the more severe anaphylactoid reactions by the absence of clinical manifestations such as bronchospasm and/or hypotension. Similar to the findings of our study, allergic reactions were also found to be the most common TR in studies done in Delhi (55.1%)^[2] and Iran (49.2%).^[17]

To establish an effective hemovigilance system and achieve the goal of safe transfusion, resident doctors and nurses in hospital wards should be made aware of the importance of safe blood transfusion practices. Reporting all major and minor transfusion events and analyzing them is essential to prevent acute TRs (ATRs).

Henceforth, preventive strategies included strict adherence to transfusion protocols, proper patient identification, leukoreduction of blood products, and premedication in high-risk individuals. Additionally, the implementation of electronic crossmatch systems and barcoding reduced human errors. Continued medical education and simulation-based training significantly improved transfusion practices among healthcare providers. Mandatory reporting through national hemovigilance programs helped in data collection and identifying systemic gaps. However, underreporting due to fear of blame or lack of awareness among staff remained a challenge. Training programs, standardized reporting formats, and root cause analyses were effective in improving compliance and data quality. Adverse TRs, while often inevitable, can be minimized through vigilant monitoring, education, and systemic improvements. Tertiary care hospitals, given their complex case load, must prioritize transfusion safety through robust hemovigilance, staff training, and continuous quality improvement measures.

CONCLUSION AND RECOMMENDATIONS

This study shows the importance of using blood and its components, improving storage conditions, bedside monitoring of transfusion and documentation of adverse events, and implementation of the hemovigilance system, thus helping to improve transfusion safety. Proper monitoring and knowledge of the signs and symptoms of the ATRs help in the early identification of these reactions and hence timely management and reporting can be done. The blood transfusion consultant, along with their clinical counterpart, is responsible for promoting awareness of safe transfusion practices to establish an effective hemovigilance system and ensure optimal patient care.