Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...
Passive transfer of CMV IgG is an unanticipated consequence of transfusion of CMV-U products and has the potential to cause morbidity. Inaccurate recording of serostatus pre-transplant has wider implications for data reporting on transplant outcomes. When transfusing CMV-U components pre-transfusion CMV IgG samples must be taken and transfusion history must be considered when interpreting results.
Introduction: Granulocyte transfusions are used to either treat or prevent life-threatening infections in neutropenic patients. Current evidence from clinical trials does not support or reject efficacy, nor guide practice. Methods: A group of investigators have led the efforts to create an online registry to gather information on granulocyte transfusion practices from as broad a range of international settings. The data forms were adapted from an on-going study in England for electronic data management. Data is collected at the time of the request for granulocytes, weekly, at 28 days, and at 6 months. Information collected includes donor, granulocyte unit, patient and illness characteristics, and outcomes. Results: The PROspective GRanulocyte usage and outcomEs Survey (ProGrES) is currently open for data entry. Centres across the UK have collected data on 80 subjects. Five institutions from 4 countries (2 from the US, 1 each from Brazil, and national services in Canada and France) are in the process of joining the study. Other countries have expressed interest. Conclusion: It is feasible to develop an international registry of granulocyte transfusions to characterise current practices and describe outcomes. This registry would provide a platform to explore the relationship between intervention and outcomes, and to generate evidence to inform granulocyte transfusion efficacy.
Supportive care for patients with acute myeloid leukaemia (AML) is defined as a broad range of interventions that ameliorate the symptoms of a disease, or the side effects caused by treatment, and which address psychological, cultural, social and spiritual factors. 1 Transfusion support and infection management are key examples of supportive care that have contributed significantly to the successes of more intensive chemotherapy, delivering improvements in outcomes despite, arguably, only modest improvements in chemotherapy regimens. 2 This article will review our current practice of transfusion therapy and infection management and identify research opportunities which the National Cancer Research Institute (NCRI) AML working party are supporting, alongside forthcoming national AML trials. How can we reduce the severity of infections in patients with AML?Infection remains a major cause of morbidity and mortality in AML. In one international study, nearly a third of patients
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