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.
Background In March 2020, a state of emergency was declared to facilitate organized responses to the coronavirus disease 2019 (COVID‐19) pandemic in British Columbia, Canada. Emergency blood management committees (EBMCs) were formed regionally and provincially to coordinate transfusion service activities and responses to possible national blood shortages. Study Design and Methods We describe the responses of transfusion services to COVID‐19 in regional health authorities in British Columbia through a collaborative survey, contingency planning meeting minutes, and policy documents, including early trends observed in blood product usage. Results Early strategic response policies were developed locally in collaboration with members of the provincial EBMC and focused on three key areas: utilization management strategies, stakeholder engagement (collaboration with frequent users of the transfusion service, advance notification of potential inventory shortage plans, and development of blood triage guidance documents), and laboratory staffing and infection control procedures. Reductions in transfusion volumes were observed beginning in mid‐March 2020 for red blood cells and platelets relative to the prepandemic baseline (27% and 26% from the preceding year, respectively). There was a slow gradual return toward baseline beginning one month later; no product shortage issues were experienced. Conclusion Provincial collaborative efforts facilitated the development of initiatives focused on minimizing potential COVID‐19–related disruptions in transfusion services in British Columbia. While there have been no supply issues to date, the framework developed early in the pandemic should facilitate timely responses to possible disruptions in future waves of infection.
Background and Objectives: Immunoglobulin (Ig) usage has ongoing shortage concerns. Secondary immunodeficiencies (SIDs) account for a major proportion of usage of Igs in Canada. We audited Ig usage in patients with SID at three British Columbia hospitals to determine whether more stringent local guidelines are necessary. Materials and Methods: A retrospective chart review was performed for patients who had Ig ordered between 1 January 2018 and 31 December 2019 for any SID indication. Cohorts were stratified into chronic and new users, and the Australian BloodSTAR guidelines were used as the benchmark at the time of conception. Having an eligible primary diagnosis, meeting SID criteria, an appropriate dosage and followup immunoglobulin G (IgG) levels encompassed appropriate usage.Results: There were no demographic differences between chronic (N = 81) and new (N = 33) cohorts. The new cohort had a higher rate of appropriate usage (45.7% vs. 66.7%, p = 0.06). The most common reason for inappropriate usage in both groups was the lack of follow-up IgG level at 6 or 12 months. Factors, displayed by relative risk (RR), associated with appropriateness included the dispensing hospital (RR: 6.60), use of subcutaneous Ig (RR: 3.84), having an IgG level before starting therapy (RR: 3.51) and documentation of clinical benefit (RR: 4.70). Conclusion:There are high rates of inappropriate Ig usage in SID patients in both new and chronically treated groups. More stringent local guidelines and processes for assessing initial and ongoing Ig replacement are warranted.
Background and Objectives Reducing the maximum red blood cell (RBC) shelf‐life is under consideration due to potential negative effects of older blood. An assessment of the impacts of this change on blood supply chain management is evaluated. Materials and Methods We performed a simulation study using data from 2017 to 2018 to estimate the outdate rate (ODR), STAT order and non‐group‐specific RBC transfusion at two Canadian health authorities (HAs). Results Shortening shelf‐life from 42 to 35 and 28 days led to the following: ODRs (in percentage) in both HAs increased from 0.52% (95% confidence interval [CI] 0.50–0.54) to 1.32% (95% CI 1.26–1.38) and 5.47% (95% CI 5.34–5.60), respectively (p < 0.05). The estimated yearly median of outdated RBCs increased from 220 (interquartile range [IQR] 199–242) to 549 (IQR 530–576) and 2422 (IQR 2308–2470), respectively (p < 0.05). The median number of outdated redistributed units increased from 152 (IQR 136–168) to 356 (IQR 331–369) and 1644 (IQR 1591–1741), respectively (p < 0.05). The majority of outdated RBC units were from redistributed units rather than units ordered from the blood supplier. The estimated weekly mean STAT orders increased from 11.4 (95% CI 11.2–11.5) to 14.1 (95% CI 13.1–14.3) and 20.9 (95% CI 20.6–21.1), respectively (p < 0.001). The non‐group‐specific RBC transfusion rate increased from 4.7% (95% CI 4.6–4.8) to 8.1% (95% CI 7.9–8.3) and 15.6% (95% CI 15.3–16.4), respectively (p < 0.001). Changes in ordering schedules, decreased inventory levels and fresher blood received simulated minimally mitigated these impacts. Conclusion Decreasing RBC shelf‐life negatively impacted RBC inventory management, including increasing RBC outdating and STAT orders, which supply modifications minimally mitigate.
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