Transfusion and Apheresis Science最新文献

By law, the National Blood Service Ghana (NBS) is responsible for the blood service in Ghana. Besides the whole blood donation program, in 2014 the NBS started a project to collect apheresis derived platelets. The project failed due to technical failures of the apheresis equipment, insufficient knowledge of clinicians of availability of single donor platelet components and the high costs of the units. NBS is planning to revive the apheresis program in early 2026 with robust apheresis equipment. Presently, therapeutic apheresis is solely available in one hospital. With the renewed introduction of the donor apheresis program in Ghana, NBS is planning to extend the use of the apheresis equipment for therapeutic procedure also.

Background and objectives: Therapeutic plasma exchange is used in the treatment of various conditions where the patient's plasma, containing antibodies or pathogenic substances, is removed while the rest of the blood components are returned. The patient's plasma volume is replaced with fluids to maintain the isovolemic volume. Various replacement fluids are available including donor plasma, human albumin and Gelofusine. This study aims to compare availability, usage, cost and serious adverse events associated with these replacement fluids in low/middle income countries (LMIC).

Materials and methods: An electronic questionnaire was sent out to clinical apheresis services in LMIC regarding availability, usage, cost and serious adverse events rates of replacement fluids: plasma, human albumin, Gelofusine. Results were collated and analysed.

Results: The main limitation to routine use of Gelofusine was its omission in the ASFA guidelines. Gelofusine was 93 % cheaper than 5 % human albumin (average cost: $1.28 versus $19.43 per 100 ml). Serious adverse event rates occurred in < 5 % of clinical apheresis procedures and were independent of replacement fluid used.

Conclusion: Gelofusine is a safe and economical replacement fluid in clinical apheresis and should be considered for procedures where plasma replacement is not a requirement. Inclusion in international guidelines will be of value.

Hematopoietic progenitor stem cells (HPSCs) are essential for restoring hematopoiesis following high-dose chemotherapy in patients with hematological malignancies, and cryopreservation enables flexibility in transplantation timing. This study evaluated the long-term viability of HPSCs processed and stored under South African National Blood Service protocols. Fifty cryopreserved products stored for 12-156 months (mean: 38.1 months) were analysed post-thaw using flow cytometry with a modified ISHAGE protocol, assessing CD34⁺ and CD45⁺ cells with 7-AAD staining. Products were considered viable if ≥ 80 % CD34⁺ and ≥ 50% CD45⁺ cells were 7-AAD-negative. All products met viability thresholds, with mean CD34⁺ viability of 98.96% (range: 87-100%) and CD45⁺ viability of 66.58% (range: 50-87%). The longest-stored product (13 years) retained 99% CD34⁺ and 59% CD45⁺ viability, and no correlation was observed between storage duration and viability. These findings confirm that HPSCs maintain high viability for up to 13 years, supporting the robustness of cryopreservation protocols and reinforcing the feasibility of long-term stem cell banking for clinical use.

Background: The Namibia Blood Transfusion Service (NAMBTS) is the sole provider of blood components in Namibia, including platelets for transfusion, which are critical for various healthcare disciplines. Rising demand and limited donor availability necessitated strategies to enhance apheresis productivity and reduce collection costs.

Methods: Beginning in 2021, the NAMBTS implemented a targeted donor-selection strategy (pre-donation platelet count ≥230 × 10^3/µL⁾ and dedicated the use of the Trima Accel™ Automated Blood Collection System (Trima; Terumo BCT) for all plateletapheresis procedures. A preliminary device comparison (n = 47) evaluated output concentration and procedure time between a legacy device (Brand A) and Trima. The five-year study (2021 - 2025) tracked performance efficiency by monitoring split-rate (proportion of donations producing two adult doses of ≥3.0 × 10¹¹ each), collection procedure time, and cost per dose.

Results: Device comparison indicated that the Trima offered a higher mean platelet output (1370 ×10^3/µL vs 1224 ×10³/µL, p = 0.0040) and shorter mean procedure time (63 vs 70 min, p = 0.0084) compared to Brand A. Over five years (2021-2025), the study achieved an average five-year split-rate of 70 %, meeting and surpassing interim targets in 2023-2024. Cumulative cost savings exceeded USD 672,378, with reduced donor burden and improved product availability. Monthly monitoring and adaptive management underpinned sustained gains.

Conclusions: Data-driven donor selection and exclusive use of Trima markedly improved plateletapheresis in Namibia. These practical, evidence-based, low-resource methods are transferable to comparable LMIC settings seeking a sustainable platelet supply.

Measurement uncertainty (MU) is increasingly recognized as a critical analytical parameter within ISO and European regulatory frameworks. In transfusion laboratories, where hemoglobin testing determines donor eligibility and informs transfusion decisions, MU directly impacts patient and donor safety. This study applies ISO/TS 20914:2019 to estimate MU in hemoglobin testing using the cyanmethemoglobin method in EDTA-K3 venous blood. A parametric simulation model informed by EFLM biological variation data was used to evaluate three scenarios: (1) within-laboratory imprecision, (2) addition of calibrator uncertainty, and (3) incorporation of significant bias uncertainty. All scenarios met desirable (2.7 %) and minimum (4.1 %) performance targets for allowable uncertainty. These findings reinforce the integration of MU estimation as a European and ISO-endorsed best practice in transfusion laboratory medicine. This approach supports traceable, risk-informed decision-making, aligning transfusion services with ISO 15189:2022 requirements.

The transfusion of ABO compatible but not ABO identical red blood cells and plasma and the transfusion of platelets and cryoprecipitate without concern for ABO in any manner, are practices that have been accepted as safe for patients. While these practices make managing blood component inventories easier by reducing component outdating, they do lead to the development of immune complexes, donor antibody induced hemolysis, and potentially endothelial cell and platelet injury. A growing body of evidence has shown that these practices are associated, likely causally, with negative consequences for patients including increased mortality. The adoption of a policy of providing only ABO identical blood components when practical, and avoiding infusion of ABO incompatible antibody, cellular and soluble antigen should thus become the optimal standard of care for patients.

Maintaining an adequate platelet supply in the United States (US) has become increasingly challenging due to stringent regulatory requirements, diminishing donor availability, and expanding clinical demand. Current US regulations require a minimum apheresis platelet yield of 3.0 × 10 ¹ ¹ per unit, a standard substantially higher than those used internationally. Implementation of bacterial risk mitigation strategies has further increased the proportion of plateletpheresis collections falling below this threshold, resulting in low-yield platelet units becoming a structurally important component of the national inventory. Analysis of US platelet utilization from 2022 to 2024 demonstrates that despite persistent supply pressures, the proportion of low-yield units remained relatively stable, while dividing of platelet units declined. Evidence from clinical studies indicates that low-yield platelets provide hemostatic efficacy comparable to standard-yield components in thrombocytopenic patients with marrow failure. However, single-center observations suggest an increase in overall platelet utilization when lower-yield units represent a larger proportion of available inventory, highlighting the influence of transfusion practices on product demand. Given ongoing supply constraints, the established availability of low-yield components, and international experience demonstrating safe use at lower minimum thresholds, reconsideration of the current US minimum plateletpheresis yield requirement is warranted. Harmonizing regulatory standards with global practice has the potential to enhance platelet availability, reduce donor burden, and strengthen national supply resilience without compromising patient safety. Further studies are needed to assess outcomes across diverse patient populations.