The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset (NCT04348656). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57–0.95 and OR = 0.66, 95% CI 0.50–0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14–2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.
Iron deficiency (ID) affects billions of people worldwide and remains the leading cause of anemia with significant negative impacts on health. Our approach to ID and iron deficiency anemia (IDA) involves three steps (I3): (1) identification of ID/IDA, (2) investigation of and management of the underlying etiology of ID, and (3) iron repletion. Iron repletion options include oral and intravenous (IV) iron formulations. Oral iron remains a therapeutic option for the treatment of ID in stable patients, but there are many populations for whom IV iron is more effective. Therefore, IV iron should be considered when there are no contraindications, when poor response to oral iron is anticipated, when rapid hematologic responses are desired, and/or when there is availability of and accessibility to the product. Judicious use of red cell blood transfusion is recommended and should be considered only for severe, symptomatic IDA with hemodynamic instability. Identification and management of ID and IDA is a central pillar in patient blood management.
BACKGROUND: The efficacy of premedication for the prevention of nonhemolytic transfusion reactions remains controversial. This systematic review and meta-analysis assessed the effect of premedication on the rate of nonhemolytic transfusion reactions after allogeneic blood transfusion. STUDY DESIGN AND METHODS:We searched the literature using CENTRAL, MEDLINE, EMBASE, ISI Web of Science, and clinicaltrials.gov databases from inception until October 31, 2018. We included all randomized controlled trials comparing premedication to placebo or no treatment in patients receiving any labile blood product. Outcome measures were reported as relative risks (RRs) with 95% confidence intervals (CIs). Data were combined for similar outcomes where appropriate using a random-effects model. Analyses were done at both the patient and transfusion level. RESULTS:Three randomized trials using acetaminophen and antihistamine as premedication met the inclusion criteria. A total of 517 patients received 4444 red blood cell or platelet transfusions. Pooled patient-level estimates with premedication for all nonhemolytic, febrile nonhemolytic, and minor allergic reactions were RR, 0.92 (95% CI, 0.63-1.35); RR, 0.54 (95% CI, 0.26-1.1); and RR, 1.37 (95% CI 0.81-2.31), respectively. Transfusion-level analyses also showed no benefit with premedication. Of 517 patients randomized, only 27 (5.2%) had a history of transfusion reactions. CONCLUSION: Routine premedication withacetaminophen and antihistamines did not prevent nonhemolytic transfusion reactions; however, the estimate of effect was greatest for febrile reactions. The impact of premedication in patients with a prior history of transfusion reactions remains unknown and requires further evaluation in future clinical trials. ABBREVIATIONS: FNHTRs = febrile nonhemolytic transfusion reactions; GRADE = Grading of Recommendations Assessment, Development, and Evaluation; MARs = minor allergic reactions; NHTRs = nonhemolytic transfusion reactions; RCTs = randomized controlled trials. From the
BACKGROUND: Platelet (PLT) transfusions are frequently administered in the setting of critical illness but their clinical impacts remain unknown. This study examined the association between PLT transfusions and death in a large intensive care unit (ICU) patient population. STUDY DESIGN AND METHODS: Using a transfusionregistry spanning 2008 to 2015, this study assessed effect of in-ICU PLT transfusions on ICU and in-hospital mortality using a stratified, time-dependent Cox proportional hazards model adjusted for illness severity, thrombocytopenia, and other confounders. Patients with known malignancy were excluded. Exposure to PLT transfusions were analyzed dichotomously (ever or never transfused) and continuously (number of transfusions). Medical, general surgery, and cardiac surgery subgroups were analyzed separately. RESULTS:Overall 32,842 adult patients were admitted to ICU, and 4927 patients received PLT transfusion(s). Crude in-ICU and in-hospital mortality were higher for PLT-transfused patients compared to nontransfused patients (9.2% vs. 6.7% and 12.3% vs. 9.3%, respectively). After confounders were adjusted for, PLT transfusions (ever vs. never) were not associated with increased mortality in ICU (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.60-1.02; p = 0.06) or in hospital (HR, 0.89; 95% CI, 0.68-1.09; p = 0.41). Continuous exposure analysis also showed no association between PLT transfusions and death. PLT transfusions have a protective effect on in-hospital mortality in the subgroup of general surgery patients (HR, 0.71; 95% CI, 0.51-0.99; p = 0.04; ever or never analysis). CONCLUSION:Platelet transfusions were not associated with increased risk of death in critically ill patients. Further studies are required to identify subgroups for which PLT transfusions may be beneficial.ABBREVIATIONS: HR = hazard ratio; ICU = intensive care unit; IQR(s) = interquartile range(s); MODS(s) = multiorgan dysfunction score(s). From the RESULTS Patient demographicsBetween 2008 and 2015, a total of 32,842 nononcology adult patients were admitted to one of three participating ICUs (Fig. 1). Median (IQR) age at admission was 66 (54-76) years and 11,944 (36.5%) of patients were female. Median (IQR) duration of ICU stay was 2 (1-4) days. Thrombocytopenia Volume 59, June 2019 TRANSFUSION 1963 PLT TRANSFUSION AND DEATH IN THE ICU * Data are reported as number (%) or median (IQR). † Cardiac surgery with cardiopulmonary bypass. ‡ Bleeding disorders include qualitative PLT defects, von Willebrand's disease, acquired factor deficiencies. § Mechanical ventilation may either be invasive or noninvasive. k MODS = multiple organ dysfunction score at baseline (range, 0-20). MODS were available for 29,550 (90.0%) of the overall patient population.
Introduction: Lumbar puncture (LP) is a frequently performed diagnostic and therapeutic intervention in adult oncology patients. While thrombocytopenia is common in this patient population, the minimum "safe" platelet count required for LPs is unknown. Recent guidelines from the AABB (American Association of Blood Banks) recommend a pre-procedure platelet count of 50 x 109/L. However this recommendation is largely based on expert opinion, and there remains a paucity of studies in the adult oncology literature to address this important question. Methods: We retrospectively reviewed all oncology patients ≥18 years who underwent 1 or more LPs over a 2 year period at a single tertiary care institution to determine 1) the range of platelet counts at which LPs are performed; 2) the rate of traumatic taps; and 3) the rate of hemorrhagic complications. Laboratory, clinical, and transfusion information were extracted through the Laboratory Information System, chart review, and blood bank database, respectively. Thrombocytopenia was defined as a platelet count of < 150 x 109/L. Pre-LP platelet counts were those collected ≤24 hours from, and closest to the time of the LP. The following bleeding risk factors were documented: end stage renal disease; platelet dysfunction; von Willebrand disease; hemophilia. Anticoagulation, anti-platelet, and non-steroidal inflammatory use was also recorded, with accuracy limited by the study's retrospective nature. All patients with coagulopathy were excluded (INR ≥ 1.5, aPTT ≥ 40, fibrinogen ≤ 1.0). Traumatic tap was defined as 500 or more red blood cells per high-power field in the cerebrospinal fluid. A follow up of 1 week after LP was used to capture any hemorrhagic complications. Results: From January 2013 to December 2014, 135 oncology patients underwent 369 LPs; 64 (47.4%) patients were female, and the mean age was 59 years (range 20-87). 119 (88.1%) patients had a primary hematological diagnosis. 113 (30.6%) LPs were performed in thrombocytopenic patients. 28 (7.6%) procedures had a pre-procedure platelet count of ≤ 50 x 109/L, with 18 receiving a single platelet transfusion on the day of the LP. Of these 18 transfusions, only 1 had a post-transfusion platelet count available prior to LP with no improvement in platelet count (33 x 109/L). 15 transfusions had post-LP platelet counts within 24 hours of the transfusion (8 below 50 x 109/L with lowest 14 x 109/L), 1 had post-LP platelet count within 24-48 hours (54 x 109/L) and 1 did not have a post-transfusion platelet count. Traumatic taps occurred in 17 (15.0%) LPs in patient with thrombocytopenia, compared to 26 (11.0%) LPs in patients with a normal platelet count (fisher's exact test P=0.39). There was 1 traumatic tap in a patient with a pre-LP platelet count of ≤ 50 x 109/L; however, this patient received a pre-LP platelet transfusion for a platelet count of 42 x 109/L and had a post-LP platelet count of 66 x 109/L. Presence of bleeding risk factors did not increase the risk of a traumatic tap (present in 48.8% of traumatic taps vs. 88.3% of non-traumatic taps). There were no hemorrhagic complications. Conclusion: Among this cohort of adult oncology patients undergoing diagnostic and therapeutic LPs, there were no hemorrhagic complications. There was no significant increase in traumatic taps in patients with thrombocytopenia or bleeding risk factors. While platelet transfusions were frequently administered for patients with a platelet count of ≤ 50 x 109/L, post-transfusion platelet counts were infrequently assessed prior to the procedure. Our findings question whether a platelet transfusion threshold of 50 x 109/L is necessary for lumbar puncture.Table 1.Platelet Count Pre-LP(x109/L)Number of LPsNumber of Traumatic TapsNumber of Hemorrhagic Complications0-90N/AN/A10-2030021-5070051-1003380101-1495270> 150242270Unknown1400< 50 x 109/L and received platelet transfusion on day of LP181*0Total369430*There was one traumatic tap in a patient with a platelet count of 42 x 109/L who received a platelet transfusion pre-LP. The post transfusion platelet count was 66 x 109/L. Disclosures No relevant conflicts of interest to declare.
Among this cohort of adult oncology patients, there were no haemorrhagic complications. Traumatic taps were not increased in patients with thrombocytopenia. The effects of platelet transfusions were rarely assessed prior to LP. Further studies should be pursued to assess whether platelet count thresholds lower than 50 × 10(9) /l are safe for lumbar puncture.
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