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.

Context:Screening for ocular manifestations of leukemia, although not a routine practice, is important as they may antedate systemic disease or form an isolated focus of its relapse.Aims:This study evaluates the spectrum of ocular manifestations in acute and chronic leukemias presenting to a tertiary care center in India.Settings and Design:Subjects of leukemia presenting to a tertiary care center in India.Subjects and Methods:A prospective, cross-sectional study looking at the spectrum of ocular manifestations in all inpatients of acute or chronic leukemia.Statistical Analysis Used:The collected data were analyzed using the Statistical Package for Social Sciences for Windows software, version 16 (SPSS Inc., Chicago, Illinois, USA).Results:The study subjects (n = 96) comprised 61 males and 35 females whose age ranged from 18 months to 91 years (mean = 39.73, ±22.1). There were 79 adults and 17 children, 53 new and 43 existing patients, 68 acute and 28 chronic, 61 myeloid and 35 lymphoid patients. Ocular lesions were found in 42 patients (43.8%). The ocular manifestations of leukemia were significantly (P = 0.01467) more frequent in acute 35/68 (51.9%) than chronic 7/28 (25%) leukemias. Primary or direct leukemic infiltration was seen in 8 (8.3%) subjects while secondary or indirect involvement due to anemia, thrombocytopenia, hyperviscosity, total body irradiation, and immunosuppression were seen in 42 (43.8%) subjects. Ocular changes were present in 37/79 (46.8%) adults and 5/17 (29.4%) children (P = 0.09460). Twenty-eight males (28/61) 45.9% and 14/35 (40%) females had ocular manifestations (P = 0.2874). The ocular manifestations were significantly (P = 0.01158) more frequent in myeloid leukemias 32/61 (52.9%) than lymphoid leukemias 10/35 (28.6%).Conclusions:Leukemic ophthalmic lesions were found in 42/96 (43.8%) patients. Ocular involvement is more often seen in adults, acute and myeloid leukemias. All the primary leukemic manifestations were seen in males. A periodic ophthalmic examination should be mandatory for all leukemic patients, as ocular changes are often picked up in asymptomatic patients.

Background and Aim:There is lack of substantial Indian data on venous thromboembolism (VTE). The aim of this study was to provide real-world information on patient characteristics, management strategies, clinical outcomes, and temporal trends in VTE.Subjects and Methods:Multicentre retrospective registry involving 549 medical records of patients with confirmed diagnosis of VTE (deep vein thrombosis [DVT] confirmed by Doppler ultrasonography; pulmonary embolism [PE] by computed tomography, pulmonary angiography and/or V/Q scan) from 2006 to 2010 at three Indian tertiary care hospitals.Results:Acute DVT without PE, acute DVT with PE, and PE alone were reported in 64% (352/549), 23% (124/549), and 13% (73/549) patients, respectively. Mean age was 47 (±16) years, and 70% were males. H/o DVT (34%), surgery including orthopedic surgery (28%), trauma (16%), and immobilization >3 days (14%) were the most common risk factors for VTE. Hypertension (25%), diabetes (19%), and neurological disease (other than stroke) (8%) were the most common co-morbidities. Most (94%) were treated with heparin alone (82%) or fondaparinux (2%) for initial anticoagulation; low molecular weight heparin alone (5%) or warfarin/acenocoumarol (76%) for long-term anticoagulation. Anticoagulant treatment was stopped because of bleeding in 2% (9/515) patients. Mortality was 7% among patients diagnosed with VTE during hospital stay versus 1% in those hospitalized with diagnosed VTE. The annual incidence of DVT (±PE) increased from 2006 to 2010.Conclusion:Acute DVT alone was responsible for the substantial burden of VTE in Indian patients. Bleeding was not the limiting factor for anticoagulant treatment in most patients.

Adolescent and young adult (AYA) patients with acute lymphoblastic leukaemia (ALL) have inferior survival when compared to children. The causes are multiple and include bad biology, differences in treatment approaches, and other complex social, economic and psychological factors that affect therapy adherence. 1 Intensive 'paediatric' regimens improve outcomes, but these come with the cost of higher toxicity, which may even negate these benefit of reduced relapse. 2-5 To understand the real-world data from India, we analysed the outcomes of AYA ALL (aged 15-29 years, treated between 2012 and 2017) from a retrospective database maintained by the Hematology Cancer Consortium (HCC). Baseline data of all patients (including those who were not treated) diagnosed within the period stipulated by a particular centre were captured, including reasons for not availing treatment. Survival outcomes were estimated for treated patients (censored on 31 July 2019). For this analysis, 'high risk' was defined based on white blood cell count (WBC) at diagnosis (B cell >30 9 10 9 /l, T cell >100 9 10 9 /l). Protocols such as Multicentre protocol 841 (MCP-841), Berlin-Frankfurt-M€ unster 95 (BFM-95), BFM-90, and Children's Oncology Group (COG) were considered 'paediatric type', whereas German Multicentre ALL (GMALL), hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (Hyper-CVAD), and UKALL were considered 'adult type'. Minimal residual disease (MRD) >0Á01% (when assessed by flow cytometry) was considered positive. Of the 1383 patients registered, 1141(82Á5%) underwent treatment (Supplementary Table S1 and S2, baseline characteristics), and 242 did not start treatment (Fig 1). The inability to afford treatment was the commonest cause for not initiating treatment (105/1383, 7Á6%). There were no Fig 1. Flowchart depicting the outcomes of patients who were included in the registry. Of the 1383 patients, only 1141 started therapy (induction) and 863 (76%) achieved complete remission (CR). At last follow-up, 574 were in CR and on follow-up. A total of 336/1383 (24%) patients either did not start therapy (N = 242), or abandoned therapy after starting induction (N = 94) (A). (B) Comparison of induction outcomes between those treated with 'paediatric' and 'adult' protocols. There were no differences in terms of achievement of CR (76% vs. 73%, P = 0Á509), induction mortality (4Á7% vs. 3Á2%, P = 0Á842), or minimal residual disease (MRD) positivity rate (36% vs. 42%, P = 0Á382). (C) The commonest cause of induction mortality was infection (56%) followed by progressive disease (23%).

The current pandemic coronavirus, SARS-CoV-2, is known to cause severe infection (COVID-19) in patients with comorbidities, particularly cancer or an immunosuppressed state. Most healthcare systems in the country are likely to be overwhelmed soon if the pandemic moves to a stage of community transmission. Currently, limited evidence is available for managing patients with hematological disorders during the COVID-19 pandemic. The current review summarises the possible challenges clinicians are likely to face, key considerations to guide decision making, and possible solutions to the anticipated challenges. Disease specific recommendations and possible guidance for decision making have been suggested for most hematologic diseases that are feasible in our health setup. It is not meant to replace individual clinical judgment, but to provide a template to formulate local policies.