Transfusion最新文献

Background: Low hemoglobin (Hb) is the leading cause of blood donor deferral yet mean Hb values are seldom examined as sentinel indicators of changes in donor recruitment, assessment, or testing. Case in point, following unexplained improvement in these parameters, U.S. blood centers observed a sharp rise in low-Hb deferrals after the 2024 introduction of a new international calibrator for some fingerstick hemoglobinometers.

Methods: We retrospectively analyzed 15 years (2010-2024) of allogeneic donor data from a national blood center. Mean donor Hb and low-Hb deferral rates were trended overall and by sex, cognizant of temporal practices affecting values like a ferritin testing program, the 2016 male Hb cutoff adjustment, and acceptance of allogeneic donors with testosterone-associated polycythemia.

Results: Among >11 million presentations (49.8% female), mean Hb values rose progressively from 2016 through 2023, correlating with a suspected gradual positive bias from a degrading hemoglobinometry standard. Female low-Hb deferrals declined from 12.2% (2016) to 7.7% (2023) before rebounding to 2016 levels in 2024 following recalibration. Male mean Hb trends were additionally influenced by increasing testosterone use in the donor base and the higher 13.0 g/dL Hb cutoff. Ferritin-based deferral programs temporarily raised mean Hb and reduced low-Hb deferrals, which reversed when suspended.

Discussion: Hemoglobinometer calibration drift, a ferritin testing policy, and donor testosterone use together shaped long-term donor Hb trends. Surveillance of mean donor Hb should be treated as a sentinel metric, and unexpected declines and increases in related deferral rates warrant the same scrutiny to protect both donors and blood availability.

Introduction: SARS-CoV-2 infection is associated with hypercoagulability in patients with Coronavirus disease (COVID-19). We used a vein-to-vein database to examine the impact of transfusion of plasma units from blood donors with recent SARS-CoV-2 infection.

Study design and methods: We linked donor SARS-CoV-2 serology data with plasma transfusions occurring between 6/1/2020 and 3/31/2022. Using multivariable regression, we examined changes in the international normalized ratio (INR) and subsequent transfusion requirements following plasma transfusion relative to the timing of donor SARS-CoV-2 nucleocapsid antibody (anti-N Ab) positivity.

Results: We identified 2350 adults who received 5397 plasma units with donor SARS-CoV-2 serology data as part of 3721 plasma transfusion events. 8.1% (436/5397) of plasma units were from anti-N Ab positive donors, and median time from index seropositivity to donation was 89 days (interquartile range [IQR] 0-210). In recipients of plasma units from recently SARS-CoV-2 infected donors (<120 days), the adjusted odds of a 0.25 per unit lowering of the INR were increased (aOR 1.6 [1.1-2.5]; p = .03) and the odds of additional plasma transfusions within 24 h were decreased (aOR 0.6 [0.4-0.9]; p = .04).

Conclusion: Recipients of plasma units from blood donors with recent SARS-CoV-2 infection were more likely to have post-transfusion reductions in the INR and less likely to require additional plasma transfusions.

Introduction: The immunomodulatory consequences of blood transfusion, known as transfusion-related immune modulation (TRIM), are often not captured by hemovigilance systems. Changes to blood product manufacturing processes may impact patient outcomes.

Design and methods: We conducted a retrospective study of hospitalized adults (≥18 years) in Hamilton, ON, who received ≥1 red blood cell (RBC) transfusion(s) between 2010 and 2014. Primary outcome was in hospital mortality; TRIM outcomes included respiratory failure, organ dysfunction, and sepsis. We evaluated outcomes before and after the change made by Canadian Blood Services (2012) to consolidate manufacturing of blood products in Ontario. Exclusions included autologous, washed, or deglycerolized RBC transfusions, RBCs manufactured outside select regional sites, or patients who received both pre-/post-consolidation RBCs. Data was obtained from the TRUST database. Logistic regression adjusted for key covariates.

Results: A total of 9871 pre- and 7871 post-consolidation patients met inclusion criteria. Multivariate analysis demonstrated no change in in-hospital mortality (odds ratio [OR] 1.00, 95% confidence interval [CI] 0.89-1.14, p = 0.95), respiratory failure (OR 0.83, CI 0.65-1.06, p = 0.14) or organ dysfunction (OR 0.95, 95% CI 0.84-1.08, p = 0.42) comparing post to pre-consolidation. However, hospital-onset sepsis was lower post-consolidation (OR 0.59, 95% CI 0.48-0.73, p < 0.001).

Conclusions: Consolidation of blood production in Ontario was not associated with changes in rates of in-hospital mortality, respiratory failure, or organ dysfunction among transfusion recipients, but may be associated with a lower risk of sepsis. TRIM and the clinical impacts of changes to blood processing require further study.

Background: Cell and gene therapies (CGTs) represent a paradigm shift in modern medicine, offering targeted and potentially curative options for complex and rare diseases. Their integration into health-system pharmacy practice requires alignment with the medication-use process to ensure safety, efficacy, and compliance.

Objective: To propose a practical framework for integrating CGTs into health-system pharmacy workflows, while addressing clinical, operational, and financial considerations.

Summary: The framework encompasses four domains: (1) evaluation-strategic assessment of pipeline therapies, including clinical, operational, and financial readiness; (2) clinical integration-formulary review, electronic medical record configuration, clinical pathways, and standard operating procedures development; (3) operational pharmacy integration-establishing infrastructure for receipt, storage, handling, and dispensing, supported by training and process improvement; and (4) financial integration-implementing reimbursement strategies, payment workflows, and budgeting to mitigate financial risk. These recommendations draw on the institutional experience of the authors and emerging standards from professional organizations.

Conclusion: Proactive planning and interdisciplinary collaboration are essential for successful CGT implementation. Health-system pharmacists are uniquely positioned to lead these efforts, ensuring patient safety, operational efficiency, and financial sustainability as advanced therapeutics reshape the healthcare landscape.

Background: Heparin combined with sodium citrate has been used in leukocytapheresis for pediatric patients. Since 2022, we have performed leukocytapheresis using a highly concentrated sodium citrate solution (HSC, 5.32%) instead of acid citrate dextrose solution A (ACD-A). We conducted this study to determine whether HSC use reduces run time and the total amount of anticoagulant solution in children.

Study design and methods: We retrospectively analyzed data from consecutive autologous peripheral blood stem cell harvests (auto-PBSCHs) between June 2012 and May 2025, including patient characteristics, mobilization methods, protocol used, anticoagulant type, run time, total anticoagulant solution volume, and collection efficiency.

Results: Auto-PBSCH was performed using the mononuclear cell collection (MNC) protocol in 28 procedures and the continuous MNC protocol in 20 procedures. ACD-A was used in 35 procedures and HSC in 13. The run time was significantly shorter (204 [range, 117-302] vs. 157 min [range, 103-227], p = .02) in the HSC group and also confirmed in multivariable regression analysis (coefficient, -55.6; 95% confidence interval, -106.2 to -5.04; p = .03). In a subgroup analysis of cMNC procedures, CD34⁺ collection efficiency showed a strong negative correlation with the proportion of run time devoted to establishing the initial interface (r = -.73, p = .0003).

Conclusion: Delays in establishing the initial interface can reduce the duration of the effective MNC collection phase and may negatively affect collection efficiency. Careful attention to the initial interface phase is therefore warranted when using HSC.

Background: Therapeutic plasma exchange (TPE) for thrombotic thrombocytopenic purpura (TTP) and auto-immune disorders involves repeated patient exposure to allogenic plasma with the risk of transfusion-transmitted infection (TTI). Amotosalen-UVA Pathogen Reduction technology is FDA approved to manufacture pathogen-reduced plasma, cryoprecipitate reduced (PRPCR), a form of cryoprecipitate poor plasma (CPP) with potentially improved TPE outcomes and reduced TTI risk.

Methods: PRPCR was manufactured from pathogen-reduced (PR) plasma. Thrombin generation, fibrinogen, Factors II, V, VII, VIII, IX, X, XI, XIII, VWF, ADAMTS13, Protein C, Protein S, α-2 plasmin inhibitor (α-2 PI), IgG, IgM, and IgA were measured. Microfluidic chamber assays at variable shear rates characterized PRPCR-mediated platelet adhesion and aggregation.

Results: Compared to PR plasma, fibrinogen, Factor VIII, and VWF levels were depleted in PRPCR. Factors II, V, VII, IX, X, XI, XIII, thrombin generation, Protein C, Protein S, α-2 PI, ADAMTS13, and immunoglobulins were conserved. At low wall shear rates (300 s^-1) PRPCR supported platelet adhesion. Perfusion of plasma-free blood containing PRPCR flowed over immobilized VWF binding peptide (100 μg/mL) and showed absence of platelet adhesion. Perfusion of plasma-free blood containing PRPCR flowed over immobilized collagen (200 μg/mL) at high wall shear rate (1500 s^-1) and demonstrated no platelet thrombus formation.

Conclusions: PRPCR retained hemostatic capacity, anti-thrombotic proteins, and ADAMTS13, but collagen induced platelet aggregation was negligible at high shear due to depletion of functional high molecular weight VWF. PRPCR is a CPP option for TPE with reduced platelet-mediated thrombotic risk and TTI risk, but with retention of plasma hemostatic capacity and immunoglobulins.

Background: Accurate quantification of residual leukocytes (rWBC) and red blood cells (rRBC) in leukoreduced blood components is essential to ensure product quality and transfusion safety. Conventional manual flow cytometry techniques are time-consuming and analyst-dependent. In this study, we validated the XN-1000 Blood Bank (BB) mode as an automated alternative and compared its performance with our standard quality control (QC) workflow.

Study design and methods: The BB mode was validated for precision, linearity, and carry-over in detecting residual cells in red blood cell concentrates, platelet concentrates, and plasma products. Results obtained were compared to those of manual flow cytometry (for rWBC and rRBC) and impedance-based hematology analysis (for platelet counts) across over 1000 blood components.

Results: Methods validation showed high linearity, acceptable precision at low cell concentrations, and no analytical interference. Comparison between workflows revealed similar results for hemoglobin, hematocrit, and leukocyte counts. rRBC values measured by BB mode were ~2.3-fold higher than those obtained by manual flow cytometry, although all values remained within product specifications. Platelet counts were consistently higher with BB mode (PLT-F) than with impedance, with a 15-51% increase depending on the product. Flow cytometry confirmed that PLT-F results better reflect the true platelet content than impedance.

Conclusion: The XN-1000 BB mode is a reliable and efficient alternative to manual methods for QC monitoring of blood components. It offers accurate residual cell quantification, increases laboratory throughput, and simplifies workflows.