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1.  Hemovigilance Program–India 
A centralized hemovigilance program to assure patient safety and to promote public health has been launched for the first time in India on Dec 10, 2012 in 60 medical colleges in the first phase along with a well-structured program for monitoring adverse reactions associated with blood transfusion and blood product administration. National Institute of Biologicals (NIB) will be the National Coordinating Centre for Hemovigilance. This program will be implemented under overall ambit of Pharmacovigilance Program of India (PvPI), which is being coordinated by Indian Pharmacopoeia Commission (IPC). All medical colleges of the country will be enrolled in this program by the year 2016 in order to have a National Centre of Excellence for Hemovigilance at NIB, which will act as a global knowledge platform.
doi:10.4103/0973-6247.106744
PMCID: PMC3613669  PMID: 23559771
Hemovigilance; India; Medical colleges; Transfusion Reaction Reporting Form
2.  Alloimmunization and autoimmunization in transfusion dependent thalassemia major patients: Study on 319 patients 
Background:
The development of anti-red blood cell antibodies (both allo-and autoantibodies) remains a major problem in thalassemia major patients. We studied the frequency of red blood cell (RBC) alloimmunization and autoimmunization among thalassemia patients who received regular transfusions at our center and analyzed the factors, which may be responsible for development of these antibodies.
Materials and Methods:
The study was carried out on 319 multiply transfused patients with β-thalassemia major registered with thalassemia clinic at our institute. Clinical and transfusion records of all the patients were examined for age of patients, age at initiation of transfusion therapy, total number of blood units transfused, transfusion interval, status of splenectomy or other interventions. Alloantibody screening and identification was done using three cell and 11 cell panel (Diapanel, Bio-rad, Switzerland) respectively. To detect autoantibodies, autocontrol was carried out using polyspecific coombs (IgG + C3d) gel cards.
Results:
Eighteen patients out of total 319 patients (5.64%) developed alloantibodies and 90 (28.2%) developed autoantibodies. Nine out of 18 patients with alloantibodies also had autoantibodies. Age at first transfusion was significantly higher in alloimmunized than non-immunized patients (P = 0.042). Out of 23 alloantibodies, 52.17% belonged to Rh blood group system (Anti-E = 17%, Anti D = 13%, Anti-C = 13%, Anti-Cw = 9%), 35% belonged to Kell blood group system, 9% of Kidd and 4% of Xg blood group system.
Conclusion:
Alloimmunization was detected in 5.64% of multitransfused thalassemia patients. Rh and Kell blood group system antibodies accounted for more than 80% of alloantibodies. This study re-emphasizes the need for RBC antigen typing before first transfusion and issue of antigen matched blood (at least for Rh and Kell antigen). Early institution of transfusion therapy after diagnosis is another means of decreasing alloimmunization.
doi:10.4103/0973-6247.137438
PMCID: PMC4140069  PMID: 25161344
Alloimmunization; autoimmunization; thalassemia major; transfusion
3.  Nucleic acid testing-benefits and constraints 
doi:10.4103/0973-6247.126679
PMCID: PMC3943139  PMID: 24678164
5.  Transfusion medicine in India: Expanding horizons 
Asian Journal of Transfusion Science  2014;8(Suppl1):S3-S5.
doi:10.4103/0973-6247.130948
PMCID: PMC4049180  PMID: 24932071
6.  Seroprevalence of human immunodeficiency virus in north Indian blood donors using third and fourth generation Enzyme linked immunosorbent assay 
Background:
The percentage of HIV cases attributable to blood transfusion has decreased significantly in the last decade. The newer 4th generation Enzyme linked immunosorbent assay (ELISA) has been shown to have increased sensitivity compared to 3rd generation ELISA.
Objectives:
To estimate the seroprevalence of HIV among blood donors using 4th generation ELISA assay and to compare it with the 3rd generation ELISA.
Materials and Methods:
This prospective study involved 10,200 blood donors- 6,800 were voluntary donors (3400-students and 3400-non students) and 3400 were replacement donors. All blood units were tested with 3rd as well as 4th generation ELISA. All samples found reactive or in grey zone with either 3rd or 4th generation ELISA were retested by Western blot (WB).
Results:
The seroprevalence of HIV was estimated to be 1.37/1000 donations (0.14%) with 3rd generation ELISA compared to 3.62/1000 donations (0.36%) with 4th generation ELISA (p>0.05). The seroprevalence of HIV among voluntary donors was estimated to be 1.32/1000 donations (0.13%) with 3rd generation ELISA and 3.67/1000 donations (0.36%) with 4th generation ELISA. The prevalence of HIV among replacement donors was 1.47/1000 donations (0.15%) with 3rd generation ELISA and 3.52/1000 donations (0.35%) with 4th generation ELISA.
Conclusion:
4th generation HIV ELISA detects a higher number of seroreactive donors compared to 3rd generation ELISA. However, larger studies are required with confirmatory tests for both 3rd and 4th generation ELISA for making any policy changes.
doi:10.4103/0973-6247.115570
PMCID: PMC3757772  PMID: 24014942
Enzyme linked immunosorbent assay; Human immunodeficiency virus; window period; transfusion associated HIV/AIDS; blood donors
9.  Analysis of adverse events and predisposing factors in voluntary and replacement whole blood donors: A study from north India 
Background:
Lack of awareness and community motivation, compounded with fragmented blood transfusion services in our country, Often leads to shortage of blood. Donor recruitment and retention are essential for ensuring adequate blood supply. However, adverse events (AEs) in donors have a negative impact on donor return.
Aims and Objectives:
The present study was aimed to assess the frequency of AEs in whole blood donors and analyze the predisposing factors for AEs.
Material and Methods:
The study was conducted on allogeneic whole blood donors over a period of 14 months, i.e., from January 2002 to February 2003. A total of 37,896 donors were monitored for any AEs: 22587 (59.6%) were voluntary donors (VD) and 15,309 (40.4%) were replacement donors (RD).
Results:
Overall reaction rate was 2.5% with vasovagal reactions constituting 63.5% and hematomas 35.0% of all reactions. Vasovagal reactions showed a significant association with young age, lower weight, first time donation status, female gender, and nature of blood donation camps. Amongst male donors, RDs had more reactions (P=0.03) than VDs. Majority of donors (85%) with vasovagal reactions admitted to some fear or anxiety prior to donation. Hematoma formation occurred significantly more when less trained staff performed phlebotomy.
Conclusion:
Donor safety is an essential prerequisite to increase voluntary blood donation. AE analysis helps in identifying the blood donors at risk of donor reactions and adopting appropriate donor motivational strategies, pre-donation counseling, and care during and after donation.
doi:10.4103/0973-6247.98922
PMCID: PMC3439755  PMID: 22988381
Adverse events; donors; vasovagal reactions
11.  Transfusion-related adverse events at the tertiary care center in North India: An institutional hemovigilance effort 
Aim:
This study was designed to analyze the incidence and spectrum of adverse effects of blood transfusion so as to initiate measures to minimize risks and improve overall transfusion safety in the institute.
Materials and Methods:
During the period from July 2002 to July 2003 all the adverse events related to transfusion of blood and blood components in various clinical specialties were recorded. They were analyzed and classified on the basis of their clinical features and laboratory tests. Attempt was also made to study the predisposing risk factors.
Results:
During the study period 56,503 blood and blood components were issued to 29,720 patients. A total of 105 adverse reactions due to transfusion were observed during the study period. A majority of the adverse reactions was observed in hemato-oncology patients 43% (n = 45) and in presensitized patient groups 63% (n = 66). FNHTR 41% (n = 43) and allergic reactions 34% (n = 36) were the most common of all types of adverse transfusion reactions, followed by AcHTR 8.56% (n = 9). Majority of these AcHTR were due to unmonitored storage of blood in the refrigerator of wards resulting in hemolysis due to thermal injury. Less frequently observed reactions were anaphylactoid reactions (n = 4), bacterial sepsis (n = 4), hypervolemia (n = 2), hypocalcemia (n = 2), TRALI (n = 1), DHTR (n = 1), and TAGvHD (n = 1).
Conclusion:
Analysis of transfusion-related adverse outcomes is essential for improving safety. Factors such as improvement of blood storage conditions outside the blood bank, improvement in cross-matching techniques, careful donor screening, adherence to good manufacturing practices while component preparation, bedside monitoring of transfusion, and documentation of adverse events will help in reducing transfusion-related morbidity and mortality.
doi:10.4103/0973-6247.83245
PMCID: PMC3159249  PMID: 21897598
Hemovigilance; transfusion reaction; adverse events of transfusion; haemolytic transfusion reaction; risk associated with transfusion
14.  Leukoreduced blood components: Advantages and strategies for its implementation in developing countries 
Removal of leucocytes from various blood products has been shown to minimize Febrile nonhemolytic transfusion reactions, HLA alloimmunization, platelet refractoriness in multitransfused patients and prevention of transmission of leukotropic viruses such as EBV and CMV. Rapidly growing size of hemato-oncological patients in our country requiring multiple transfusion of blood and components during the course of their management pose a great challenge to transfusion services to provide them red cell and platelet antigen matched products in alloimmunized subjects. Thus removal of leucocytes below a certain threshold, ≤ 5 × 106 in a blood component certainly helps in prevention of alloimmunization and associated risks in these patients. Currently the best Leucoreduction can be achieved with the help of 3rd and 4th generation leukofilters, both in laboratory and patient bed side, and state of the art apheresis devices. The present article briefly reviews the current literature for pros and cons of leucofilteration and its scope of implementation in the cost constrained settings.
doi:10.4103/0973-6247.59384
PMCID: PMC2847337  PMID: 20376259
Blood component; developing countries; leukoreduced component
15.  Quality assessment of platelet concentrates prepared by platelet rich plasma-platelet concentrate, buffy coat poor-platelet concentrate (BC-PC) and apheresis-PC methods 
Background:
Platelet rich plasma-platelet concentrate (PRP-PC), buffy coat poor-platelet concentrate (BC-PC), and apheresis-PC were prepared and their quality parameters were assessed.
Study Design:
In this study, the following platelet products were prepared: from random donor platelets (i) platelet rich plasma - platelet concentrate (PRP-PC), and (ii) buffy coat poor-platelet concentrate (BC-PC) and (iii) single donor platelets (apheresis-PC) by different methods. Their quality was assessed using the following parameters: swirling, volume of the platelet concentrate, platelet count, WBC count and pH.
Results:
A total of 146 platelet concentrates (64 of PRP-PC, 62 of BC-PC and 20 of apheresis-PC) were enrolled in this study. The mean volume of PRP-PC, BC-PC and apheresis-PC was 62.30±22.68 ml, 68.81±22.95 ml and 214.05±9.91 ml and ranged from 22-135 ml, 32-133 ml and 200-251 ml respectively. The mean platelet count of PRP-PC, BC-PC and apheresis-PC was 7.6±2.97 × 1010/unit, 7.3±2.98 × 1010/unit and 4.13±1.32 × 1011/unit and ranged from 3.2 –16.2 × 1010/unit, 0.6-16.4 × 1010/unit and 1.22-8.9 × 1011/unit respectively. The mean WBC count in PRP-PC (n = 10), BC-PC (n = 10) and apheresis-PC (n = 6) units was 4.05±0.48 × 107/unit, 2.08±0.39 × 107/unit and 4.8±0.8 × 106/unit and ranged from 3.4 -4.77 × 107/unit, 1.6-2.7 × 107/unit and 3.2 – 5.2 × 106/unit respectively. A total of 26 units were analyzed for pH changes. Out of these units, 10 each were PRP-PC and BC-PC and 6 units were apheresis-PC. Their mean pH was 6.7±0.26 (mean±SD) and ranged from 6.5 – 7.0 and no difference was observed among all three types of platelet concentrate.
Conclusion:
PRP-PC and BC-PC units were comparable in terms of swirling, platelet count per unit and pH. As expected, we found WBC contamination to be less in BC-PC than PRP-PC units. Variation in volume was more in BC-PC than PRP-PC units and this suggests that further standardization is required for preparation of BC-PC. As compared to the above two platelet concentrates, all the units of apheresis-PC fulfilled the desired quality control criteria of volume. Apheresis-PC units showed better swirling and platelet count than PRP-PCs and BC-PCs. All the platelet concentrates units had pH well above the recommended norm.
doi:10.4103/0973-6247.53882
PMCID: PMC2920479  PMID: 20808653
Corrected count increment; buffy coat poor-platelet concentrate; percentage recovery; platelet concentrate; platelet rich plasma-platelet concentrate; random donor platelet; single donor platelets

Results 1-15 (15)