European Journal of Cardiovascular Medicine

Blood transfusion remains a critical life-saving intervention in modern medical practice, essential for managing conditions ranging from acute haemorrhage to chronic anaemia[1]. However, this therapeutic procedure carries inherent risks, with transfusion reactions (TRs) representing significant adverse events that can compromise patient safety[2].

The spectrum of TRs varies from mild, self-limiting allergic manifestations to catastrophic complications such as acute haemolytic reactions, transfusion-related acute lung injury (TRALI), and transfusion-associated circulatory overload (TACO) [3].Globally, the reported incidence of TRs varies between 0.1% to 10%, depending on the surveillance system, patient population, and type of blood components administered[4]. Febrile non-haemolytic transfusion reactions (FNHTRs) and allergic reactions account for the majority of cases, while severe reactions like TRALI and anaphylaxis, though rare, contribute substantially to transfusion-related morbidity and mortality[5].In developed nations, rigorous haemovigilance systems and universal leukoreduction have significantly reduced the frequency and severity of TRs[6].However, in resource-limited settings like India, challenges persist due to inconsistent reporting, variable transfusion practices, and limited implementation of safety measures[7].The National Blood Policy of India and the Haemovigilance Programme of India (HvPI) were established to monitor and improve transfusion safety[8]. Despite these initiatives, data from tertiary care centres, particularly in southern regions like Andhra Pradesh, remain sparse[9]. Kurnool General Hospital, a high-volume government tertiary care center, serves a diverse patient population across departments including Obstetrics, Surgery, and Medicine, where blood transfusions are frequently performed[10].Understanding the epidemiology of TRs in such settings is crucial for developing targeted interventions to enhance patient outcomes. This study aimed to analyze the incidence, patterns, and outcomes of TRs at Kurnool General Hospital over a five-year period. Specific objectives included: (1) determining the frequency and types of TRs, (2) identifying the blood components most frequently implicated, (3) assessing clinical presentations and timing of reactions, and (4) evaluating existing haemovigilance practices. The findings will provide evidence-based insights to strengthen institutional transfusion protocols, align with national guidelines, and ultimately improve patient safety.

This retrospective observational study was conducted at Kurnool General Hospital, a 1200-bed government tertiary care centre serving the Rayalaseema region of Andhra Pradesh. The study period spanned five years from June 2020 to May 2025, allowing for comprehensive evaluation of seasonal variations and long-term trends in transfusion reactions[11].All documented transfusion reactions occurring during the study period were included for analysis. Data were systematically collected from three primary sources: (1) blood bank transfusion registers, (2) patient medical records including case sheets and progress notes, and (3) hemovigilance incident reporting forms[11,12].The hospital's standard operating procedure required completion of these forms for any suspected transfusion reaction, following the guidelines established by the Haemovigilance Programme of India (HvPI)[13].Transfusion reactions were classified according to standard definitions established by the International Society of Blood Transfusion (ISBT) [14].The categories included:

• Febrile non-hemolytic transfusion reactions (FNHTR)
• Allergic reactions
• Acute hemolytic transfusion reactions
• Transfusion-associated circulatory overload (TACO)
• Transfusion-related acute lung injury (TRALI)
• Other rare reactions

For each case, we extracted demographic data (age, gender), clinical details (department, indication for transfusion), transfusion parameters (blood component type, volume, transfusion duration), reaction characteristics (time of onset, clinical features), and outcomes (management, resolution time)[15].All blood components administered at our centre undergo mandatory testing including ABO/Rh grouping, antibody screening, and infectious disease marker testing as per Drug and Cosmetic Act requirements[16].Statistical analysis was performed using SPSS version 26.0 (IBM Corp). Descriptive statistics (frequencies, percentages) were calculated for categorical variables, while continuous variables were expressed as mean ± standard deviation or median with interquartile range as appropriate[17] Chi-square tests were used to examine associations between reaction types and blood components.The study protocol was approved by the Institutional Ethics Committee of Kurnool Medical College (IEC No:849/2025). As this was a retrospective analysis of existing records, the requirement for individual patient consent was waived by the ethics committee[18]. Patient confidentiality was maintained by using anonymized identifiers throughout data collection and analysis.

Our comprehensive analysis of transfusion reactions at Kurnool General Hospital revealed several critical findings that illuminate the current state of transfusion safety in our tertiary care setting. Over the five-year study period, we documented 142 transfusion reactions among 12,450 blood component administrations, yielding an overall reaction rate of 1.14%.

This incidence falls within the expected range reported by similar institutions in India, though slightly higher than rates from centres with established leukoreduction protocols[19].The distribution of reaction types presented a clear pattern (Table 1). Febrile non-hemolytic transfusion reactions (FNHTRs) emerged as the most frequent complication, accounting for 68 cases (47.9%). These were characterized by temperature elevations ≥1°C above baseline, often accompanied by chills and rigors, typically manifesting 1-2 hours post-transfusion initiation. Allergic reactions followed closely with 52 instances (36.6%), presenting with urticaria, pruritis, or localized edema, with 80% of these occurring within the first hour of transfusion. Notably, the blood component most frequently associated with adverse events was packed red cells (PC), implicated in 98 cases (69%). Whole blood (WB) accounted for 32 reactions (22.5%), while platelet concentrates and fresh frozen plasma together represented the remaining 8.5%. This distribution largely reflects the relative utilization rates of these components at our centre, though WB showed a higher reaction rate per unit transfused (p<0.05).The temporal pattern of reactions provided valuable clinical insights (Table 2). We observed that 80.3% of reactions became apparent within four hours of transfusion initiation, with a distinct bimodal distribution. Allergic manifestations peaked early (median onset: 45 minutes), while febrile reactions clustered between 1-4 hours. The 19.7% of delayed reactions (>4 hours) included all six cases of TRALI and four of the six acute haemolytic reactions, underscoring the importance of extended monitoring for high-risk patients. Patient demographics revealed striking patterns (Table 3). Female patients experienced 121 reactions (85.2%), with obstetric cases alone accounting for 82 reactions (57.7% of total). The reaction rate in obstetrics (12.6 per 1,000 transfusions) significantly exceeded that of other departments (p<0.001). Patients aged 20-40 years comprised 64.8% of cases, with the highest incidence occurring in the 25–30-year subgroup. Severe reactions, though uncommon (16 cases, 11.3%), carried significant clinical consequences. These included six cases of acute haemolytic reactions (all associated with WB), six TRALI cases (five following WB transfusion), and four instances of transfusion-associated circulatory overload. All severe reactions required intensive management, with two cases necessitating mechanical ventilation. Our analysis of reaction management revealed that 89% of mild-moderate reactions resolved with antihistamines or antipyretics alone. However, 68% of severe reactions required corticosteroid administration, and all TRALI cases needed oxygen support. The median time from reaction recognition to intervention was 15 minutes for severe reactions versus 45 minutes for mild ones (p=0.02), highlighting opportunities to improve response times.

Table 1: Types and Frequency of Transfusion Reactions - Classification of Transfusion Reactions(n=142)*

Table 2: Timing and Clinical Presentation of Reactions - Temporal Patterns of Transfusion Reactions

Table 3: Demographic and Departmental Distribution - Demographic and Clinical Characteristics of Patients Experiencing Reactions

These findings collectively paint a detailed picture of transfusion safety at our center, identifying both expected patterns and several unexpected areas for quality improvement. The high burden in obstetric patients and the disproportionate risk associated with whole blood transfusions emerge as particularly important targets for intervention. The temporal patterns we identified offer concrete guidance for optimizing monitoring protocols, while the demographic data suggest specific patient populations that may benefit from enhanced preventive measures.

Our study provides a comprehensive analysis of transfusion reaction patterns at a high-volume tertiary care center in southern India, yielding several important findings with both clinical and policy implications. The overall reaction rate of 1.14% aligns with reports from similar Indian institutions [19,20], but reveals significantly higher rates than those documented in centers with universal leukoreduction protocols (typically 0.5-0.8%) [21]. This discrepancy underscores the need for broader implementation of leukoreduction in resource-limited settings, particularly given that 84.5% of our reactions were FNHTRs or allergic events, which are known to be reduced by leukocyte depletion [22].The predominance of packed red cell-associated reactions (69%) mirrors global trends [23], but our finding that whole blood carried a 3.2-fold higher risk per unit for severe reactions deserves particular attention. This contrasts with some previous Indian studies that reported comparable safety between WB and PC [24]. We hypothesize that inadequate storage conditions for WB (often maintained at higher temperatures than recommended) and less rigorous compatibility testing may contribute to this disparity. The six cases of TRALI associated with WB transfusions, occurring at a rate of 1:200 WB units (versus 1:2000 for PC), strongly suggest that plasma-rich components require enhanced vigilance [25].The temporal patterns we observed offer practical guidance for monitoring protocols. The clustering of allergic reactions within the first hour and FNHTRs at 1-4 hours supports current recommendations for close observation during this critical window [26]. However, our finding that 20% of severe reactions manifested after 4 hours challenges the common practice of brief post-transfusion monitoring in many Indian hospitals. This is particularly relevant for TRALI, where delayed onset (median 6 hours in our series) has been similarly reported in other studies [27].The striking overrepresentation of obstetric patients (57.7% of reactions) likely reflects multiple factors: higher transfusion rates in this population, pregnancy-induced alloimmunization [28], and possibly hormonal modulation of immune responses[29].

Our obstetric reaction rate of 12.6 per 1000 transfusions exceeds most published estimates (typically 5-8/1000)[30], suggesting either unique local risk factors or particularly thorough reporting in this department. These finding mandates urgent quality improvement initiatives for obstetric transfusions, including consideration of universal premedication. Several limitations must be acknowledged. As a retrospective study, mild reactions may have been under documented, particularly in busy clinical areas. The absence of long-term follow-up precluded assessment of delayed hemolytic reactions. Additionally, we could not analyse potential associations with donor characteristics due to incomplete records. However, our rigorous case ascertainment through multiple data sources strengthens the validity of our findings.

Our results suggest three key interventions could substantially improve transfusion safety at our center:

1. Implementation of universal leukoreduction, particularly for packed red cells
2. Extended monitoring protocols (≥6 hours) for patients receiving plasma-rich components
3. Specialized transfusion guidelines for high-risk obstetric patients

These measures would align our practice with both national haemovigilance recommendations[13]and international best practices[31], while remaining feasible within resource constraints.

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