Objectives: Convalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. Design: Open-label, parallel-arm, phase II, multicentre, randomized controlled trial. Setting: Thirty-nine public and private hospitals across India. Participants: Hospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 ≤ 93% on room air). Intervention: Participants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome Measure: Composite of progression to severe disease (PaO2/FiO2<100) or all-cause mortality at 28 days post-enrolment. Results: Between 22 nd April to 14 th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. Interpretation: CP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19.
Background and Objective:Therapeutic Plasma Exchange (TPE) is performed effectively and safely in adult patients, but the use of TPE is limited in paediatric patients due to lack of universally accepted indications and technical challenges like establishment of adequate vascular access, low blood volume, increased incidence of adverse events during procedure and poor co-operation of patients during procedure. We present our experience of TPE in paediatric patients to assess the effectiveness and safety of TPE in paediatric patients.Materials and Methods:A total 122 TPE procedures were performed in 40 paediatric patients between 3 to 15 years of age group with Guillain Barre Syndrome (GBS). TPE procedures were performed on alternate days depending on the clinical condition of the patient. Patient's total blood volume was calculated as per Nadler's formula and processed through central double lumen catheter. 1-1.5 plasma volume was exchanged with normal saline and fresh frozen plasma.Results:A total of 122 TPE procedures (with an average of three procedures per patient) were performed on 40 paediatric patients. More than three TPE procedures were performed in 29 patients, of which 27 patients showed improvement from grade-0 and grade-I to grade-III. One did not show any response and succumbed to the disease. Complications were observed in 14 patients which were well managed. Inadequate vascular access was most common complication observed in 11 patients.Conclusion:TPE in paediatric patients has been increasing and has been shown to be effective as first line or adjunctive therapy in selected diseases. It is safe procedure when volume shifts, calcium supplementation and venous access are taken care.
Background:Hepatitis E virus (HEV) is emerging as a potential threat to blood safety after several cases of transmission by transfusion or transplantation have been described. Currently, blood donors in India are not screened for HEV. The studies conducted on HEV in recent times in India have focused on epidemiology and future perspectives, but there is no published study on blood donors. To address possible issues surrounding blood safety and risk of HEV transmission within the Indian blood supply, HEV seroprevalence study was conducted in blood donors at our center.Materials and Methods:A total of 460 male voluntary blood donors were selected for the study and after taking their written consent. Serum anti-HEV IgM was detected by Dia.Pro HEV kit (Diagnostic Bioprobes Srl, Milano, Italy).Results:The study population was composed of 460 male voluntary blood donors and their age ranged from 18 to 60 years with a mean age of 30.48 years. Out of 460 donors, 22 (4.78%) donors were tested positive for IgM anti-HEV and the mean value alanine aminotransferase (ALT) was 26.06 IU/L, the highest being 93.5 IU/L. Normal reference value of ALT in our center was 40 IU/L. Out of 22 anti-HEV positive donors, 19 (86.36%) had ALT values above 40 IU/L.Conclusion:HEV seroprevalence of 4.78% in our center. Though reports of HEV transmission through blood has been reported from various parts of the world, before making it as a mandatory screening test among blood donors in India, further studies with confirmatory assay of HEV need to be done.
BACKGROUND AND OBJECTIVES: The aim of the blood transfusion service should be to provide effective blood and blood components, which are as safe as possible and adequate to meet patient's need. To achieve safe blood transfusion practice, many blood transfusion center in India follow routine type and screen protocol for all patient's and donor's blood samples to detect unexpected alloantibodies. The present study is aimed at assessing the frequency and type of unexpected red cell alloantibodies in general patient population and donors at a tertiary care teaching hospital in western India. MATERIALS AND METHODS: In this prospective study, samples of patients as well as blood donors were processed for ABO and Rh “D” grouping as well as antibody screening with three cell screening panel on fully automated immunohematology analyzer. Positive sample in three cell screening panel was further evaluated for identification of specific alloantibody with eleven cell identification panel by column agglutination technique. Results were recorded, and data were analyzed to calculate the frequency of unexpected alloantibody. RESULTS: A total of 74,214 patient samples and 80,173 donor samples were processed for type and screen. Out of which, 512 patients and 11 donors were identified with alloantibody. Most common alloantibody found in the present study is anti-D (0.075%), followed by anti-E (0.041%), anti-c (0.021%), anti-K (0.0205%) in Rh and Kell blood group system. CONCLUSION: Antibody screening and identification of specific alloantibody help in identifying most appropriate blood unit that lacks the corresponding antigen and prevent alloimmunization.
Introduction:Partial phenotyping of voluntary blood donors has vital role in transfusion practice, population genetic study and in resolving legal issues. The Rh blood group is one of the most complex and highly immunogenic blood group known in humans. The Kell system, discovered in 1946, is the third most potent system at triggering hemolytic transfusion reactions and consists of 25 highly immunogenic antigens. Knowledge of Rh & Kell phenotypes in given population is relevant for better planning and management of blood bank; the main goal is to find compatible blood for patients needing multiple blood transfusions. The aim of this study was to evaluate the frequency of Rh & Kell phenotype of voluntary donors in Gujarat state.Materials and Methods:The present study was conducted by taking 5670 samples from random voluntary blood donors coming in blood donation camp. Written consent was taken for donor phenotyping. The antigen typing of donors was performed by Qwalys-3(manufacturer: Diagast) by using electromagnetic technology on Duolys plates.Results:Out of 5670 donors, the most common Rh antigen observed in the study population was e (99.07%) followed by D (95.40%), C (88.77%), c (55.89%) and E (17.88%). The frequency of the Kell antigen (K) was 1.78 %.Discussion:The antigen frequencies among blood donors from Gujarat were compared with those published for other Indian populations. The frequency of D antigen in our study (95.4%) and north Indian donors (93.6) was significantly higher than in the Caucasians (85%) and lower than in the Chinese (99%). The frequencies of C, c and E antigens were dissimilar to other ethnic groups while the ‘e’ antigen was present in high frequency in our study as also in the other ethnic groups. Kell antigen (K) was found in only 101 (1.78 %) donors out of 5670. Frequency of Kell antigen in Caucasian and Black populations is 9% & 2% respectively. The most common Kell phenotype was K-k+, not just in Indians (96.5%) but also in Caucasians (91%), Blacks (98%) and Chinese (100%).Conclusion:Phenotype and probable genotype showed wide range of variations in different races and religion. Reliable population based frequency data of Rh & Kell antigens has vital role in population genetic study, in resolving medico legal issues and in transfusion practice.
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