Demographics and appropriateness of cellular blood component irradiation practices: Ambispective analysis from a tertiary care center.

BACKGROUND: Transfusion-associated graft versus host disease (TA-GVHD) is often underreported. There may also be lapses in TA-GVHD prevention practices due to lack of revision of some of the existing clinical guidelines as well as limited audits on practices of blood component irradiation. This study was undertaken to highlight these shortcomings, and generate data for development of institutional guidelines. METHODS/MATERIALS: Study cohort was selected from patients requiring transfusion support during June 2019 to May 2020. Transfusion history of these patients were followed, both retrospectively and prospectively till July 2021. Transfusion requisitions were categorized as IR (with request for irradiation) or NIR (with no request for irradiation) and justified or unjustified according to published international guidelines. RESULTS: Total 6963 requisitions for cellular blood components were received from 255 patients included in the study cohort. Of these, 3690 (54.9 %) were IR requisitions, while remaining 3029 (45.1 %) requisitions were NIR. Overall, 4242 (63.1 %) requisition were justified for their irradiation status as per published guidelines and 1595 (23.8 %) were found to be Unjustified while justification could not be assessed for remaining 882 (13.1 %) of the requisitions. The highest proportion of Unjustified demands in NIR requisitions was observed in patients with Severe Aplastic anemia (59.4 %). CONCLUSION: Many units were unnecessarily irradiated (7.7 %) while irradiation was missed in 16 % of the requisitions included in analysis which may be attributed to lack of institutional guidelines. We recommend that every centre should adopt a published well-researched guideline including amendments based on review of practices at their center.

Posterior reversible encephalopathy syndrome following blood transfusion in a patient with factor X deficiency: Is it an unusual systemic manifestation of an adverse transfusion reaction?

Adverse neurological transfusion reactions including posterior reversible encephalopathy syndrome (PRES) following blood transfusion are rare. Our case an 18-year-female with known Factor X deficiency with menorrhagia developed severe hypertension, followed by generalised tonic clonic convulsions apparently after blood component transfusion. She had earlier received 4 units of red blood cells (RBC) for anaemia and 10 units of fresh frozen plasma (FFP) for menorrhagia (with prolonged PT and APTT) within short span of time at another hospital. There was no history of hypertension, convulsions, any cardiovascular, renal or neurological disease before transfusion. The clinical features and magnetic resonance imaging findings led to the diagnosis of PRES. Abnormal electroencephalogram and a hypercoagulable haemostatic profile on thromboelastography along with derangement in blood glucose and liver function tests were also observed. Patient responded well to the anticonvulsants and antihypertensive agents prescribed and was discharged in a stable condition. Our patient had a systemic transfusion reaction involving predominantly neurological system, however, cardiovascular, hepatic, haemostatic and endocrine systems were also affected. This case is unusual being the first report of PRES occurring in a patient with factor X deficiency presenting with an array of clinical and laboratory features which have not been reported in earlier studies involving PRES. Presumably the initial aggressive red cell transfusion to treat anaemia initiated the crisis and further large volumes of transfused FFP contributed to this adverse transfusion reaction in our case. Clinicians and Transfusion Medicine specialists should be aware about this uncommon clinical entity.

Are Buffy-coat Pooled Platelet Concentrates an Effective Alternative to Apheresis Platelet Concentrates? An In vitro Analysis at a Tertiary Care Center in Northern India.

Background: There is a need for platelet products to have the best quality. Apheresis platelet concentrates (PCs) obtained from single-donors PCs (SD-PCs) are considered best but have issues such as feasibility and cost. Buffy-coat pooled PCs (BCP-PCs) are considered an alternative to SD-PCs. This study compares BCP-PCs and SD-PCs for in vitro quality parameters and their changes during storage. Materials and Methods: Fifteen units of BCP-PCs and 15 units of SD-PCs were prepared. In this study, a pool of five buffy coats was prepared. Fifteen units of BCP-PCs were analyzed on day 1 and day 5 of storage, while 15 SD-PCs were analyzed on day 1 while ten units on day 5. The parameters analyzed were volume, hematological parameters, pH, swirling, and sterility. Results: The mean platelets count of SD-PCs was found to be significantly higher as compared to BCP-PCs. White blood cells (WBCs) contamination was significantly lower in BCP-PCs as compared to SD-PCs. The mean pH and mean platelet volume of SD-PCs were significantly lower than BCP-PCs. During storage, the mean platelets count of BCP-PCs was decreased significantly while that of SD-PCs nonsignificantly. The mean WBCs count and pH decreased in both BCP-PCs and SD-PCs significantly. All units in both types of PCs were sterile. Conclusion: Platelet yield was significantly better in SD-PCs, while mean WBCs contamination was significantly lower in BCP-PCs. BCP-PCs may be preferred in place of SD-PCs in case of nonavailability of apheresis, difficulty in finding a willing donor, or when the cost is of consideration.

Prevalence of the Direct Antiglobulin Test and Its Clinical Impact on Multiply Transfused Thalassemia Patients: A Prospective Study Conducted at a Tertiary Care Center in Northern India.

OBJECTIVE: This study was conducted to estimate prevalence of direct antiglobulin test (DAT) positivity and its impact on transfusion support in patients with thalassemia. METHODS: The DAT testing was performed for patients with ß-thalassemia who received transfusion from November 2021 to March 2022. Elution was done for DAT-positive samples. RESULTS: Of 180 patients, 21 (11.6%) were DAT positive. Immunoglobulin G (IgG) was present in 4 (19%) and IgG+C3d was present in 8 (38%). Only complement was present in 9 (42.8%) patients. The IgG-reactive DATs were associated with pan-reactive eluate. Patients who were DAT-positive had significantly higher levels of serum bilirubin, ferritin, and IgG than those who were DAT-negative. CONCLUSION: Autoantibody formation in multiply transfused thalassemia patients is common and merits equal attention as alloimmunization. It is particularly important as DAT-positive red blood cells may undergo clinically significant hemolysis, which may increase the transfusion requirements with associated sequalae such as increased serum ferritin and splenomegaly.

Red cell alloimmunization and associated risk factors in multiply transfused thalassemia patients: A prospective cohort study conducted at a tertiary care center in Northern India.

BACKGROUND: One of the complications of chronic transfusions in thalassemia is the development of red cell alloimmunization. AIMS: The aim of the study was to determine the frequency, specificity of red cell alloantibodies, and factors influencing alloimmunization in multiply transfused thalassemia patients. MATERIALS AND METHODS: The study was carried out prospectively on beta-thalassemia patients over 10 months. Plasma samples were used for antibody screening and identification using the column agglutination technique. Patients' clinical, laboratory, and transfusion details were obtained from hospital information system and patient files. STATISTICAL ANALYSIS: Continuous variables were reported as median and quartile, whereas categorical variables were provided as numbers and proportions. P < 0.05 was considered statistically significant. RESULTS: Out of 255 patients, 17 (6.6%) patients developed alloantibodies. Alloimmunized patients had significantly higher median ages at their first transfusions (1 year vs. 0.5 years; P = 0.042) than nonalloimmunized patients. Alloimmunized patients had significantly higher conjugated bilirubin (P = 0.016) and serum ferritin (P = 0.007). The majority of alloantibodies had specificity toward K antigen, followed by E, C, D, JKa, and JKb antigens. Alloimmunized patients received more units per year than nonalloimmunized patients (median, 30 vs. 24 units; P < 0.001). The average transfusion interval time between two successive transfusions showed a significant difference (P < 0.001). CONCLUSIONS: The prevalence of alloimmunization in thalassemia patients in North India is relatively low. Since most of the alloantibodies belong to Rh and Kell blood group system, extended phenotype-matched blood for Rh and Kell will be helpful in further preventing or decreasing the development of alloantibodies in multiply transfused thalassemia patients.

Events at blood collection area due to nonconforming blood bags and plateletpheresis kits: need for timely corrective and preventive actions.

BACKGROUND: Good blood banking practice requires that every effort should be made to detect any deviation or defect in blood bank products and to identify any potential risk to blood donor or recipient(s). We report the findings of an exercise that provide an insight into why feedback from the user side is crucial. STUDY DESIGN AND METHODS: Various events involving blood bags and plateletpheresis kits and the corresponding appropriate actions instituted for remedial measures were recorded. These scattered events were recorded for 6 months following the use of a new batch of improved blood bags with add-on features. Several events related to plateletpheresis kits from three different manufacturers were also recorded for 1 year. RESULTS: The affected blood bags were utilized with no untoward incident. The complaint was closed following satisfactory response from the blood bag manufacturing company that acted in a timely manner in addressing the root causes of the problems. However, corrective and preventive actions (CAPA) could not be implemented for plateletpheresis kits. The rate of undesirable events was higher with plateletpheresis kits as compared with whole blood bags (1.75% vs. 0.06%). CONCLUSION: As defects or deviations that trigger the need for CAPA can stem from numerous sources, it is important to clearly identify and document the problems and level of risk so that appropriate investigations can be instituted and remedial actions can be taken in a timely manner. This study demonstrates the usefulness of a quality initiative to collate and analyze blood product faults in conjunction with blood product manufacturers.

Error reporting in transfusion medicine at a tertiary care centre: a patient safety initiative.

BACKGROUND: Errors in the transfusion process can compromise patient safety. A study was undertaken at our center to identify the errors in the transfusion process and their causes in order to reduce their occurrence by corrective and preventive actions. METHODS: All near miss, no harm events and adverse events reported in the 'transfusion process' during 1 year study period were recorded, classified and analyzed at a tertiary care teaching hospital in North India. RESULTS: In total, 285 transfusion related events were reported during the study period. Of these, there were four adverse (1.5%), 10 no harm (3.5%) and 271 (95%) near miss events. Incorrect blood component transfusion rate was 1 in 6031 component units. ABO incompatible transfusion rate was one in 15,077 component units issued or one in 26,200 PRBC units issued and acute hemolytic transfusion reaction due to ABO incompatible transfusion was 1 in 60,309 component units issued. Fifty-three percent of the antecedent near miss events were bedside events. Patient sample handling errors were the single largest category of errors (n=94, 33%) followed by errors in labeling and blood component handling and storage in user areas. CONCLUSIONS: The actual and near miss event data obtained through this initiative provided us with clear evidence about latent defects and critical points in the transfusion process so that corrective and preventive actions could be taken to reduce errors and improve transfusion safety.

Late onset neonatal anaemia due to maternal anti-Kp(b) induced haemolytic disease of the newborn.

BACKGROUND: Alloanti-Kp(b) is a rare, clinically significant antibody against high frequency red cell antigen Kp(b) of Kell blood group system. We report here a case of Haemolytic disease of newborn (HDN) due to anti-Kp(b), which manifested as severe anaemia at the age of 1 month. AIM: To diagnose and successfully manage anti-Kp(b) induced HDN. METHODOLOGY: Direct antiglobulin test (DAT), antigen typing, irregular antibody screening and identification were done by polyspecific LISS Coombs Gel card and standard methods. RESULTS: At presentation the neonate had severe anemia with reticulocytopenia. Blood group was B, Rh D positive and DAT was 2+. Anti-Kp(b) was detected in mother's serum. Due to unavailability of Kp(b) negative red cells and incompatible blood group of mother (A(1)B Rh D positive) infant was transfused group B Rh D, Kp(b) positive PRBCs under steroid cover. He was symptom free at 4 months of age and DAT became negative at 6 months. CONCLUSION: Anti-Kp(b) is capable of causing severe late HDN. Infants born to irregular antibody positive mothers should be investigated and closely monitored for several weeks after birth for immune HDN even if asymptomatic at birth.

Root cause analysis of transfusion error: identifying causes to implement changes.

BACKGROUND: As part of ongoing efforts to improve transfusion safety, an error reporting system was implemented in our hospital-based transfusion medicine unit at a tertiary care medical institute. This system is based on Medical Event Reporting System-Transfusion Medicine (MERS-TM) and collects data on all near miss, no harm, and misadventures related to the transfusion process. Root cause analyses of one such innocuous appearing error demonstrate how weaknesses in the system can be identified to make necessary changes to achieve transfusion safety. STUDY DESIGN AND METHODS: The reported error was investigated, classified, coded, and analyzed using MERS-TM prototype, modified and adopted for our institute. RESULTS: The consequent error was a "mistransfusion" but a "no-harm event" as the transfused unit was of the same blood group as the patient. It was a high event severity level error (level 1). Multiple errors preceded the final error at various functional locations in the transfusion process. Human, organizational, and patient-related factors were identified as root causes and corrective actions were initiated to prevent future occurrences. CONCLUSION: This case illustrates the usefulness of having an error reporting system in hospitals to highlight human and system failures associated with transfusion that may otherwise go unnoticed. Areas can be identified where resources need to be targeted to improve patient safety.

Seroprevalence of Toxoplasma gondii antibodies in North Indian blood donors: implications for transfusion transmissible toxoplasmosis.

INTRODUCTION: Transfusion transmitted Toxoplasma gondii (T. gondii) can result in significant clinical consequences in immunocompromised and multiply transfused patients, pregnant women and fetus etc. Anti-T. gondii seroprevalence, specifically IgM antibodies reflect the risk of transfusion transmission. METHODS: Four hundred and ninety-three blood donors in a tertiary care hospital in North India were screened for IgG and IgM anti-T. gondii antibodies by enzyme linked immunosorbent assay (ELISA). RESULTS: The prevalence of IgG and IgM anti-T. gondii antibodies was 51.8% and 5% respectively. The prevalence was higher in females (M=51.6%, F=89.2%) and in replacement donors (replacement donors=63.2%, voluntary donors=33.5%). CONCLUSION: The donor population constitutes a significant risk of transfusion transmitted toxoplasmosis. Effective strategies are required to prevent transfusion transmitted toxoplasmosis.

Circulating thrombopoietin levels in normal healthy blood donors and in aplastic anemia patients in relation to disease severity.

BACKGROUND: Thrombopoietin (TPO) is the key hematopoietic growth factor regulating the production of platelets from bone marrow megakaryocytes and maintaining platelet hemostasis. This study was done to find any relationship between the levels of thrombopoietin and the severity of disease in patients with aplastic anemia. MATERIALS AND METHODS: Serum samples were collected from 52 patients with a confirmed diagnosis of aplastic anemia and 45 normal healthy blood donors of both sexes over a period of 2 years, and TPO was estimated by using commercially available TPO-specific-enzyme-linked immunosorbent assay. RESULTS: The median TPO level of 1190 pg/ml (range 625-7651 pg/ml) in aplastic anemia patients was significantly higher than the median TPO level of 121.1 pg/ml (81.25-237.7 pg/ml) in normal healthy blood donors (P = 0.000). No significant difference was observed in TPO levels of male and female patients (P = 0.453). The median TPO concentrations observed in very severe aplastic anemia, severe aplastic anemia, and nonsevere aplastic anemia were 2765 pg/ml (range 625-6451 pg/ml), 1190 pg/ml (range 672.1-7651 pg/ml), and 1111.5 pg/ml (range 761.1-2289.2 pg/ml), respectively. TPO in patients of very severe aplastic anemia was significantly higher than patients of nonsevere aplastic anemia (P = 0.043), with no significant relation among rest of the groups. DISCUSSION: TPO levels in aplastic anemia patients were significantly higher than in healthy blood donors; however, in aplastic anemia patients TPO levels were significantly higher only in patients with very severe disease.

Red blood cell antibodies in thalassemia patients in northern India: risk factors and literature review.

Study of the factors responsible for red cell alloimmunization can help in adopting appropriate strategy to minimize alloimmunization. However data for thalassemia patients from our region is limited. Therefore, a study was conducted to find out the frequency and the factors associated with red cell allo and autoimmunization in thalassemia patients at our center so as to enable us to take appropriate action to reduce alloimmunization. Clinical, demographic, allo and autoantibody and transfusion records of 280 thalassemia patients at our hospital were studied. Patients with and without alloantibodies were compared to find significant differences for age, gender, race, age at start of regular transfusions and splenectomy. Red cell antigen frequencies in thalassemia patients and published antigen frequencies in blood donors from the same center were compared to look antigen differences as a risk factor for alloimmunization. Twenty four thalassemia patients (8.6 %) developed 28 clinically significant alloantibodies. 18 (65 %) of the alloantibodies were of Rh system. The three most common antibodies detected was anti E (11, 39.3 %) followed by anti K (6, 21.4 %) and anti c (10.8 %). Five (1.8 %) of the 280 patients developed autoantibodies. Patient age was found to be significantly higher in alloimmunized patients than in non alloimmunized patients. Red cell antigen frequencies between blood donor and recipient populations were found to be homogenous for most of the relevant RBC antigens. The frequency of red cell alloimmunization in thalassemia patients from our center is moderate. In this setting of red cell phenotype concordant donor-recipient population requirement of extended phenotype matched transfusions may not be cost effective.

Cross-match-compatible platelets improve corrected count increments in patients who are refractory to randomly selected platelets.

BACKGROUND: Cross-match-compatible platelets are used for the management of thrombocytopenic patients who are refractory to transfusions of randomly selected platelets. Data supporting the effectiveness of platelets that are compatible according to cross-matching with a modified antigen capture enzyme-linked immunosorbent assay (MAC-ELISA or MACE) are limited. This study aimed to determine the effectiveness of cross-match-compatible platelets in an unselected group of refractory patients. MATERIALS AND METHODS: One hundred ABO compatible single donor platelet transfusions given to 31 refractory patients were studied. Patients were defined to be refractory if their 24-hour corrected count increment (CCI) was <5×10(9)/L following two consecutive platelet transfusions. Platelets were cross-matched by MACE and the CCI was determined to monitor the effectiveness of platelet transfusions. RESULTS: The clinical sensitivity, specificity, positive predictive value and negative predictive value of the MACE-cross-matched platelets for post-transfusion CCI were 88%, 54.6%, 39.3% and 93.2%, respectively. The difference between adequate and inadequate post-transfusion 24-hour CCI for MACE cross-matched-compatible vs incompatible single donor platelet transfusions was statistically significant (p=0.000). The 24-hour CCI (mean±SD) was significantly higher for cross-match-compatible platelets (9,250±026.6) than for incompatible ones (6,757.94±2,656.5) (p<0.0001). Most of the incompatible cross-matches (73.2%) were due to anti-HLA antibodies, alone (55.3% of cases) or together with anti-platelet glycoprotein antibodies (17.9%). DISCUSSION: The clinical sensitivity and negative predictive value of platelet cross-matching by MACE were high in this study and such tests may, therefore, be used to select compatible platelets for refractory patients. A high negative predictive value demonstrates the greater chance of an adequate response with cross-matched-compatible platelets.

Anti- c(w): in a young female patient. A case report with review of literature and frequency of low incidence c(w) (rh8) antigen in north India.

If the patient has antibody to low incidence antigen providing compatible blood for transfusion is not a problem. It is however necessary to identify such antibodies to assess their potential to cause hemolytic transfusion reaction and hemolytic disease of newborn. We identified anti C(w) in patient's serum while investigating the cause of incompatible cross match in a female thalassemia patient. Anti C(w) is an antibody against C(w) (Rh8) antigen, which is a low incidence antigen of Rh system. This case also prompted us to study frequency of C(w) antigen in our donor population as the frequency of C(w) antigens in our population is not reported. Frequency of C(w) antigens in north Indian donors was found to be 1.2 %.

Evaluation of transfusion-related complications along with estimation of inhibitors in patients with hemophilia: A pilot study from a single center.

BACKGROUND: Apart from inhibitor development in patients with hemophilia (PWH) the old problems of blood borne viral infections and red cell alloimmunization still persist in PWH from developing countries. This study was planned to detect the presence of inhibitors in our PWH and to determine the presence of transfusion transmitted infections (TTI) markers and clinically significant red cell alloantibodies in these patients. MATERIALS AND METHODS: One hundred fourteen PWH were screened for various laboratory tests. Screening for inhibitors was done by mixing study. Blood grouping, TTI testing and red cell alloantibody detection were done as per the departmental standard operating procedures. RESULTS: Out of 114 patients evaluated 98(86%) had hemophilia A and remaining 16(14%) had hemophilia B. Five (5.1%) patients of hemophilia A were positive on inhibitor screening. On Bethesda assay, one patient was high responder (14.4 BU/ml) and rest 4 were low responders (<5 BU/ml). Overall, 19 PWH were positive for TTI markers and two had clinically significant red cell alloantibody (anti-E and anti-Jk(b)). CONCLUSION: This is probably first comprehensive study from our state on laboratory testing in PWH. The specialty of Transfusion Medicine can be a core part of hemophilia care. The overall prevalence of inhibitors in our hemophilia A patients was 5.1%, which is less as compared to majority of published studies.

Seroprevalence of malaria in blood donors and multi-transfused patients in Northern India: Relevance to prevention of transfusion-transmissible malaria.

BACKGROUND: Transfusion-transmissible malaria (TTM) is a major concern in malaria endemic countries. A study was therefore conducted to know sero-prevalence of malaria in blood donors and the risk of TTM to multi-transfused patients at our hospital. MATERIALS AND METHODS: STUDY SUBJECTS WERE: eligible blood donors (n = 1000), donors deferred due to history of fever in the last 3 months (n = 100), and multi-transfused patients (n = 200). Screening for malaria was done by slide microscopy, immunochromatographic rapid diagnostic test (RDT) for malaria antigen, and anti-malaria antibody by enzyme linked immunosorbent assay. RESULTS: Malaria antibody prevalence in eligible donors and donors with history of fever, thalassemia patients, and in other multi-transfused patients was 16.9%, 22%, 6%, and 15%, respectively. None of the donors were positive for malaria on microscopic examination. None of the blood donors except one donor with history of fever, tested positive with RDT. CONCLUSION: Malaria antibody prevalence in blood donors at our center is high. As blood units donated by such donors have high-risk potential, special processing may be undertaken to reduce the risk of TTM.