Apheresis Research Articles

Comparative analysis of the quality of platelet concentrates produced by apheresis procedures, platelet rich plasma, and buffy coat.

Platelet concentrates (PCs) could be prepared using either whole-blood processes or apheresis instruments. During collection, processing and storage, some biochemical and functional changes occur, which may result in quality reduction. Quality evaluation of PCs may be helpful for the precise control of platelet (PLT) inventory to reduce the risk of refractoriness and adverse effects caused by platelet transfusion. The study was aimed to evaluate the quality of PCs which were produced by five processes: apheresis (AP) procedures (using three different cell separators: Amicus, Trima Accel and MCS+ instruments), platelet rich plasma (PRP), and buffy coat (BC). A total of 100 PCs (20 of each group) were assessed in respect of routine quality control, morphology, size distribution, destroyed and activated platelets, and production of platelet-derived microparticles (PMPs). All PCs have satisfied the recommended quality of volume, platelet count, residual WBC count, residual RBC count, pH, and sterility according to the Chinese Technical Manual. There was no difference among the 5 groups in morphology and size of PLT and PMPs. Dynamic light scattering test showed that apheresis PCs showed peaks around 10-20 nm, but not whole blood-derived PCs. PCs prepared by Amicus had the relatively high percentage of destroyed platelet, activated platelets and PMPs than other groups. The data suggested high heterogeneity of PMPs, destroyed and activated platelets in PCs produced by different processes, which might be helpful to manage the platelet inventory for targeted use.

Varnimcabtagene Autoleucel (IMN-003A): Differences in T Cell Subset Phenotype in B-ALL and B-NHL Cohorts Did Not Influence Efficacy Outcomes in the Phase-2 Study (IMAGINE)

Background: Varnimcabtagene autoleucel (IMN-003A) is an autologous CD19 directed CAR-T cell product with a 4-1BB co-stimulatory domain and a non-FMC63 murine single chain variable fragment (A3B1 binder), manufactured in India, tested in the IMAGINE study (CTRI/2022/03/041162), a phase-2 clinical trial for patients (pts) with relapsed and/or refractory B cell malignancies. A fractionated infusion of 1 x 10 6 CAR+ cells (IMN-003A)/kg for B-ALL cohort and 5 x 10 6 CAR+ cells (IMN-003A)/kg for B-NHL cohort was administered over 3 days (10%, 30%, 60%). Phenotypic data comparing the apheresis (AP) and final product (FP) from B-ALL and B-NHL cohorts, related manufacturing and clinical response observations are discussed in this abstract. Methods: IMN-003A was manufactured using the Miltenyi CliniMACS Prodigy®, a cGMP compliant closed system. The apheresis and final infusion product (FP) were analysed for percent CAR transduction and T cell subsets by flow cytometry. CAR copies in the final product were determined by ddPCR. Cell counts measured using automated Vi-cell counter were used to calculate fold expansion. Results: Apheresis PBMC from 25 patients in the IMAGINE study were selected for T-cells, transduced & expanded to achieve the FP, which was infused in 24 patients (1 patient withdrawn). Three patients needed a second apheresis and re-manufacturing to achieve the target dose. The FP comprised primarily of CD3+ T cells (median 99.38%, range 96.3 - 99.92%) with mean of 38.18% CAR+ T cells for B-ALL cohort (range: 20.28 - 58.35%) and significantly lower 27.53% CAR+ T-cells for B-NHL cohort (range: 8.5 - 51.07%, p=0.02). The vector copy number (VCN) however did not differ between the two cohorts (mean of 2.66 and 2.37 copies for B-ALL and B-NHL cohorts respectively; p=0.4). The fold expansion at Day 6 of manufacturing was also significantly lower for B-NHL cohort (6.93) compared to the B-ALL cohort (10.33, p=0.02). Consistent with the relatively more challenging manufacturing for the B-NHL cohort with 5 times higher target dose, it was observed that the mean proportion of naïve T-cells (CCR7 + CD45RA +) was lower in both AP (B-NHL 9.71%, B-ALL 27.24%, p<0.01) and FP (B-NHL 16.68%, B-ALL 48.94%, p<0.0001), while the terminally differentiated T EMRA and effector memory T EM subsets were higher in the AP (B-NHL 53.8%, B-ALL 45.08%, p=0.175) & FP (B-NHL 48.77%, B-ALL 29.54%, p=0.021), highlighting the T-cell phenotypic differences in the two cohorts. The mean CD4/CD8 ratio in AP & FP was 0.56 and 1.14 respectively. There was reversal of CD4/CD8 ratio from apheresis to final product (CAR+ T cells, ratio=3.37) which was statistically significant (p<0.01). The CD4:CD8 ratio did not differ between B-ALL and B-NHL cohorts. This could potentially be explained by the higher proportion of naïve T-cells observed within CD4 subset compared to CD8 subset as against the proportion of T EMRA cells. Despite the higher fraction of CD4 CAR-T cells within the final product infused, post-infusion, there was a statistically significant trend (p<0.01) towards reversal of CD4/CD8 ratio in the peripheral blood from D0 to D+90. Ongoing flow-cytometry based analysis shall help further characterise the CAR+ T-cells post-infusion. Interestingly, despite phenotypic differences in T-cell subsets between B-ALL and B-NHL, overall response rate (ORR) at D+90 was very similar for both cohorts [B-ALL 80% (n=8/10); B-NHL 81.8% (9/11)]. Updated results shall be presented at the meeting. Conclusions: Differences in the manufacturing outcomes (CAR % transduction, fold expansion) and T cell phenotype (naïve and effector T EMRA cell subsets) were observed in Apheresis and FP, between the B-ALL and B-NHL cohorts. A higher fraction of relatively more differentiated T cell phenotypes of effector (T EMRA) and effector memory (T EM) and a lower fraction of naïve T cells in the B-NHL cohort and within CD8 T cells, reflects a manufacturing conundrum for B-NHL patients with a higher target dose and the CD4:CD8 ratio in the final product. However, these differences in the final product did not adversely impact the clinical responses at D+90 with equivalent efficacy in both cohorts. The ideal T cell phenotype or their proportions within the final product for maximum efficacy thus remains uncertain. A deeper characterisation including exhaustion status of the apheresis, final product and post-infusion samples for the T cell subsets can provide further insights.

Efficacy of cytapheresis in patients with ulcerative colitis showing insufficient or lost response to biologic therapy.

For the optimal management of refractory ulcerative colitis (UC), secondary loss of response (LOR) and primary non-response to biologics is a critical issue. This article aimed to summarize the current literature on the use of cytapheresis (CAP) in patients with UC showing a poor response or LOR to biologics and discuss its advantages and limitations. Further, we summarized the efficacy of CAP in patients with UC showing insufficient response to thiopurines or immunomodulators (IM). Eight studies evaluated the efficacy of CAP in patients with UC with inadequate responses to thiopurines or IM. There were no significant differences in the rate of remission and steroid-free remission between patients exposed or not exposed to thiopurines or IM. Three studies evaluated the efficacy of CAP in patients with UC showing an insufficient response to biologic therapies. Mean remission rates of biologics exposed or unexposed patients were 29.4 % and 44.2%, respectively. Fourteen studies evaluated the efficacy of CAP in combination with biologics in patients with inflammatory bowel disease showing a poor response or LOR to biologics. The rates of remission/response and steroid-free remission in patients with UC ranged 32%-69% (mean: 48.0%, median: 42.9%) and 9%-75% (mean: 40.7%, median: 38%), respectively. CAP had the same effectiveness for remission induction with or without prior failure on thiopurines or IM but showed little benefit in patients with UC refractory to biologics. Although heterogeneity existed in the efficacy of the combination therapy with CAP and biologics, these combination therapies induced clinical remission/response and steroid-free remission in more than 40% of patients with UC refractory to biologics on average. Given the excellent safety profile of CAP, this combination therapy can be an alternative therapeutic strategy for UC refractory to biologics. Extensive prospective studies are needed to understand the efficacy of combination therapy with CAP and biologics.

Effect of bedside filtration on aggregates from cold-stored whole blood-derived platelet-rich plasma and apheresis platelet concentrates.

The current approach to manufacture cold-stored platelets (CSP) replicates that of room temperature-stored platelets (RSP). However, this production method is associated with aggregate formation in CSP, a major pitfall that leads to significant wastage. We hypothesized that isolating platelets from whole blood as platelet-rich plasma (PRP) and storing them at a lower concentration reduces aggregates and that conventional bedside transfusion filtration removes CSP aggregates. We collected platelets from healthy humans by apheresis (AP) and by phlebotomy, from which we generated platelet-rich plasma (PRP). We split each AP and PRP platelets into two equal aliquots, storing one at 22°C (RT-PRP and RT-AP) and the other at 4°C (4C-PRP and 4C-AP). We evaluated platelets on day 0 and day 7 of storage. After storage, we measured platelet counts, aggregates, and other key characteristics before and after filtration by a bedside filter. After storage, the 4C-AP platelet counts decreased significantly. 4C-PRP preserved glucose better and prevented a significant increase in lactate contrary to 4C-AP. Filtration led to significantly lower platelet counts in both 4C-PRP and 4C-AP but not in their RT counterparts. Post filtration, we observed 50% fewer aggregates only in 4C-AP, whereas 4C-PRP showed an unexpected but significant increase in aggregates. Testing confirmed activation during storage but filtration did not further activate platelets. We provide evidence that 4C-PRP is an alternative to 4C-AP and that bedside filters reduce aggregates from 4C-AP. Further studies are needed to evaluate the hemostatic potential of 4C-PRP and the management of aggregates.

Number Of Apheresis Days To Reach Target Stem Cell Dose May Be a Predictor Of Secondary Myelodysplastic Syndrome and Acute Myelogenous Leukemia

Introduction Autologous stem cell transplantation (ASCT) is an effective consolidation therapy for patients with relapsed/refractory Hodgkin's and Non-Hodgkin's lymphoma. Studies have shown that infusion of at least 2 × 106 CD34+ cells/kg recipient body weight is required for reliable neutrophil and platelet engraftment. However there is no published data on the impact of number of apheresis days required to reach the target stem cell dose and incidence of secondary myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML). Methods Consecutive patients who underwent ASCT at M. D. Anderson cancer center from January 2008-July 2011 for Hodgkin's or Non-Hodgkin's lymphoma were evaluated to assess the impact of duration of mobilization on the incidence of secondary MDS/AML. Baseline patient, disease, and transplant characteristics including number of days of mobilization needed to collect target cell dose of 5 × 106 CD34+ cells/kg. The median number of days to reach target was 2 (range 1-5) days. We used the median as cut off to classify patients as slow (> 2 days) or fast (≤ 2 days) mobilizers. The cumulative incidence of secondary MDS/AML was estimated considering death preceding a secondary malignancy as a competing event. Cox's proportional hazards regression analysis was used to evaluate predictors of the rate of secondary MDS/AML. Results A total of 283 patients underwent ASCT during the study period. 153 of these patients were classified as fast mobilizers and 130 patients as slow mobilizers. Indication for transplant, disease status prior to transplant, age and gender distribution are as shown in [Table 1][1]. Twelve patients were diagnosed with secondary MDS/AML after a median follow-up of 39 (range 2-64) months. Only one of these patients had pre-existing pretransplant cytogenetic abnormalities (monosomy 7 in one metaphase). Nine of 12 cases were diagnosed within 3 years post-transplant. On univariate analysis, days to target stem cell dose was the only predictor of the rate of secondary MDS/AML. The rate of secondary MDS/AML within 3 years post-transplant was higher in the slow mobilizer group (n=8, 6% cumulative incidence at 3 yrs) compared with the fast mobilizer group (n=4, 1 % cumulative incidence at 3 yr, HR=0.2, P value 0.05) [Figure 1][2]. None of the remaining factors listed in [Table 1][1] were found to be associated with the rate of secondary MDS/AML on univariate analysis. In patients who did not have active disease at transplant, overall survival tended to be higher in the fast mobilizer group compared with slow mobilizers. However, this effect did not reach statistical significance on multivariate analysis (hazard ratio of 0.6; with P value of 0.1). Absolute neutrophil count of > 500/mm3 was achieved at a median of 10 days in fast mobilizers versus 11 days in slow mobilizers (P value 0.000). Similarly platelet count >20,000 was achieved sooner in fast mobilizers at a median of 11 versus 12.5 days in slow mobilizers (P value 0.000). View this table: Table 1 Conclusions Number of apheresis days required to collect target stem cell may be a predictor of secondary MDS/AML. There is a trend towards better survival among patients who mobilize in two or less than two days. As expected fast mobilizers have quicker neutrophil and platelet engraftment. ![Figure 1][3] Figure 1 Disclosures: Qazilbash: Millennium: Membership on an entity’s Board of Directors or advisory committees; Celgene: Membership on an entity’s Board of Directors or advisory committees. [1]: #T1 [2]: #F1 [3]: pending:yes

Cytapheresis re-induces high-rate steroid-free remission in patients with steroid-dependent and steroid-refractory ulcerative colitis.

BACKGROUNDIt is a crucial issue for patients with refractory ulcerative colitis (UC), including steroid-dependent and steroid-refractory patients, to achieve and maintain steroid-free remission. However, clinical studies focused on the achievement of steroid-free remission in refractory UC patients are insufficient. Cytapheresis (CAP) is a non-pharmacological extracorporeal therapy that is effective for active UC with fewer adverse effects. This study comprised UC patients treated with CAP and suggested the efficacy of CAP for refractory UC patients.AIMTo clarify the efficacy of CAP in achieving steroid-free remission in refractory UC patients.METHODSWe retrospectively reviewed the collected data from 55 patients with refractory UC treated with CAP. We analyzed the following points: (1) Efficacy of the first course of CAP; (2) Efficacy of the second, third, and fourth courses of CAP in patients who experienced relapses during the observation period; (3) Efficacy of CAP in colonic mucosa; and (4) Long-term efficacy of CAP. Clinical efficacy was evaluated using Lichtiger’s clinical activity index or Sutherland index (disease activity index). Mucosal healing was evaluated using Mayo endoscopic subscore. The primary and secondary endpoints were the rate of achievement of steroid-free remission and the rate of sustained steroid-free remission, respectively. Statistical analysis was performed using the paired t-test and chi-squared test.RESULTSThe rates of clinical remission, steroid-free remission, and poor effectiveness after CAP were 69.1%, 45.5%, and 30.9%, respectively. There were no significant differences in rate of steroid-free remission between patients with steroid-dependent and steroid-refractory UC. The mean disease activity index and Lichtiger’s clinical activity index scores were significantly decreased after CAP (P < 0.0001). The rates of steroid-free remission after the second, third, and fourth courses of CAP in patients who achieved steroid-free remission after the first course of CAP were 83.3%, 83.3%, and 60%, respectively. Mucosal healing was observed in all patients who achieved steroid-free remission after the first course of CAP. The rates of sustained steroid-free remission were 68.0%, 60.0%, and 56.0% at 12, 24, and 36 mo after the CAP. Nine patients (36%) had maintained steroid-free remission throughout the observation period.CONCLUSIONOur results suggest that CAP effectively induces and maintains steroid-free remission in refractory UC and re-induces steroid-free remission in patients achieving steroid-free remission after the first course of CAP.

The effect of pathogen inactivation on cryoprecipitate: a functional and quantitative evaluation.

As a pooled donor blood product, cryoprecipitate (cryo) carries risks of pathogen transmission. Pathogen inactivation (PI) improves the safety of cryoprecipitate, but its effects on haemostatic properties remain unclear. This study investigated protein expression in samples of pathogen inactivated cryoprecipitate (PI-cryo) using non-targeted quantitative proteomics and in vitro haemostatic capacity of PI-cryo. Whole blood (WB)- and apheresis (APH)-derived plasma was subject to PI with INTERCEPT® Blood System (Cerus Corporation, Concord, CA, USA) and cryo was prepared from treated plasma. Protein levels in PI-cryo and paired controls were quantified using liquid chromatography-tandem mass spectrometry. Functional haemostatic properties of PI-cryo were assessed using a microparticle (MP) prothrombinase assay, thrombin generation assay, and an in vitro coagulopathy model subjected to thromboelastometry. Over 300 proteins were quantified across paired PI-cryo and controls. PI did not alter the expression of coagulation factors, but levels of platelet-derived proteins and platelet-derived MPs were markedly lower in the WB PI-cryo group. Compared to controls, WB (but not APH) cryo samples demonstrated significantly lower MP prothrombinase activity, prolonged clotting time, and lower clot firmness on thromboelastometry after PI. However, PI did not affect overall thrombin generation variables in either group. Data from this study suggest that PI via INTERCEPT® Blood System does not significantly impact the coagulation factor content or function of cryo but reduces the higher MP content in WB-derived cryo. PI-cryo products may confer benefits in reducing pathogen transmission without affecting haemostatic function, but further in vivo assessment is warranted.

Characteristics of autologous peripheral blood stem cells collection over a one-year period.

Aim To present characteristics of collecting autologous peripheral blood stem cells over a one-year period with an emphasis on efficiency and safety. Methods A retrograde analysis of 24 leukapheresis in 20 adult patients with malignant haematological diseases in the Blood Transfusion Institute of the Federation of Bosnia and Herzegovina in Sarajevo, was done. Cell separators Amicus and Spectra Optia were used for collection procedures. Results The patient's age ranged from 27 to 65 years. Target cells were collected in one procedure in sixteen patients, while in four patients they were collected in two procedures. The mean CD34+ collection efficiency was 57.7%. The median number of CD34+ cells and percentage of CD34+ cells in the products were 5.52x10e6/kg (range 3.28-9.00) and 1.57% (range 0.96-2.91). A strong positive correlation was found between the number of CD34+ cells in peripheral blood on the apheresis day and the amount of CD34+ cells collected in the products (rs =0.73). A total of 95% of patients collected the amount of ≥3x10e6/kg and 55% of ≥5x10e6/kg CD34+ cells for a single transplant. A decrease in platelet count, haemoglobin and haematocrit values after the procedure was not significant. Potassium decrease showed statistical significance (p<0.000). Adverse events occurred during one procedure (4.2%). Conclusion A low number of adverse events and good collection efficiency with adequate patient monitoring, indicate that leukapheresis is a safe procedure that is successfully used in the autologous transplantation process in the treatment of malignant haematological diseases.

Bacterial contamination rate of platelet components by primary culture: a systematic review and meta-analysis.

Platelets have the highest bacterial contamination risk of all blood components, and septic transfusion reactions remain a problem. A good estimate of contamination rates could provide information about residual risk and inform optimal testing strategies. We performed a systematic review and meta-analysis of platelet contamination rates by primary culture. A literature search in December 2019 identified articles on platelet contamination rates using primary culture. We used meta-analysis to estimate the overall rate of contamination and meta-regression to identify heterogeneity. We studied the following sources of heterogeneity: collection method, sample volume, positivity criteria, and study date. Contamination rate estimates were obtained for apheresis (AP), platelet rich plasma (PRP), and buffy coat (BC) collection methods. The search identified 6102 studies, and 22 were included for meta-analysis. Among these 22 studies, there were 21 AP cohorts (4,072,022 components), 4 PRP cohorts (138,869 components), and 15 BC cohorts (1,474,679 components). The overall mean contamination rate per 1000 components was 0.51 (95% CI: 0.38-0.67) including AP (0.23, 95% CI: 0.18-0.28), PRP, (0.38, 95% CI: 0.15-0.70), and BC (1.12, 95% CI: 0.51-1.96). There was considerable variability within each collection method. Sample volume, positivity criteria, and publication year were significant sources of heterogeneity. The bacterial contamination rate of platelets by primary culture is 1 in 1961. AP and PRP components showed a lower contamination rate than BC components. There is clinically significant between-study variability for each method. Larger sample volumes increased sensitivity, and bacterial contamination rates have decreased over time.

Study on the ineffective platelet transfusion in patients with hematologic malignancies during myelosuppression

Objective To investigate the causes of ineffective platelet transfusion in patients with hematologic malignancies during myelosuppression and the therapeutic effect of rituximab. Methods A total of 180 patients with different hematologic malignancies in the First People's Hospital of Changzhou from January 2017 to December 2018 were selected. And the incidence of ineffective platelet transfusion during myelosuppression was observed. The changes of T and B lymphocyte subgroups and platelet counts before and after rituximab therapy in acute leukemia patients with platelet antibody-positive were compared, and the incidence of ineffective platelet transfusion with different platelet suspensions was analyzed. Results The ineffective platelet transfusion was observed in 45 of 180 patients (25.0%) during myelosuppression, including 30 (27.8%) of 108 patients with acute leukemia, 10 (23.3%) of 43 patients with myelodysplastic syndrome, 2 (13.3%) of 15 patients with malignant lymphoma, and 3 (21.4%) of 14 patients with multiple myeloma. The incidence of ineffective platelet transfusion in patients transfused with irradiated leukocyte depleted apheresis platelets (17.0%, 16/94) was lower than that in those with apheresis platelets (33.7%, 29/86), and the difference was statistically significant (χ2 = 6.68, P = 0.01). In 8 acute leukemia patients with platelet antibody-positive and the ineffective platelet transfusion after rituximab therapy, the increase of platelet count was observed in 5 patients. The differences of levels of CD19, CD20, CD4 and platelet count before and after treatment with rituximab were statistically significant (all P < 0.05). Conclusions The incidence of ineffective platelet transfusion is the highest in acute leukemia patients. Transfusion of human leukocyte antigen-matched platelets can improve the effect of platelet transfusion. Rituximab is effective in the ineffective platelets transfusion caused by immune factors. The incidence of ineffective platelet transfusion in irradiated leukocyte depleted apheresis platelets is lower compared with that in apheresis platelets. Key words: Hematologic neoplasms; Myelosuppression; Platelet transfusion; Medical futility

Discharge and Contents of Exosome from Leukocyte-Reduced Apheresis Platelet Stored for Different Storage Time

To explore the effect of storage time on discharge and content of exosome from leukocyte-reduced apheresis platelets (LRA-Plt). Exosome (EXO) from LRA-Plt were acquired by ExoQuick, and its' morphology, immunological marker and particle size distribution were detected by transmission electron microscopy (TEM), Western blotting and dynamic light scattering (DLS), respectively. The changes in particle size distribution of EXO from LRA-Plt with different storage time were detected by DLS. The changes in content of protein and RNA of EXO from LRA-Plt with different storage time were detected by Nanodrop® ND-2000. EXO from LRA-Plt was acquired successfully, which was characterized by cup-like shape, CD63/TSG101 enriched and Calnexin negative, and the particle size of which ranged from 30 to 200 nm. At early stored stage (stored for 1 day and 2 days), particle size of EXO from LRA-Plt was small and ranges from 30 to 40 nm. Meanwhile, the contents of protein and RNA were low. The particle size distribution, contents of protein and RNA of EXO from LRA-Plt were not significanty different ammg groups (P＞0.05). At middle-late stored stage (stored for 3, 4 and 5 days), the particle size of EXO from LRA-Plt was larger than that of early stored stage, which ranges was from 130 to 200 nm. Meanwhile, the contents of protein and RNA were higher than those of early stored stage. Particle size distribution, contents of protein and RNA of EXO from LRA-Plt stored for middle-late stage were significant higher than those of early stored stage (P＜0.05). Morphology of EXO from LRA-Plt stored for middle-late stage was different from that stored for early stored stage. Moreover, the particle size distribution, contents of protein and RNA of EXO from LRA-Plt stored for middle-late stage were higher than those of early stored stage. A large amount of protein and RNA contained in EXO from LRA-Plt may participate in the multiple functions caused by platelet transfusion.

Analysis of scrapping reasons for apheresis platele consumables used in Chengdu Blood Center

Objective To explore the scrapping reasons for the apheresis platele consumables of 3 different types blood cell separators used in Chengdu Blood Center. Methods From January 2015 to December 2017, a total of 63 782 sets of apheresis platelets consumables used in Chengdu Blood Center and Tianfu Blood Donation House were selected as subjects. Among them, the apheresis platelets consumables of MCS+ , Amicus, Trima Accel blood cell separators were 28 351, 15 482 and 19 949 sets, respectively. Retrospective investigation method was adopted to inquire the material scrapping situation in the resource management of Chengdu Blood Center and Tianfu Blood Donation House, through the Qiao Blood Station Management System. And the scrapping amount and reasons of apheresis platele consumables were counted, and were checked with the scrapping records from Consumables Scrap Statistics in Apheresis Room. Reasons for scrapped of apheresis platele consumables include consumable factors (pipe wrinkles, breakage, leakage, etc.) and collection factors (venipuncture failure, machine fault, chylemia blood, red blood cell overflow, blood donation response, etc.). After the data were verified correctly, the scrapping rates of apheresis platelets consumables were calculated. The scrapping rates of different blood cell separators and different scrapping reasons were compared by chi-square test, respectively. Results ① Among the 63 782 sets of apheresis platelets consumables, a total of 900 sets were scrapped, with a scrapping rate of 1.41% (900/63 782). The scrapping rate of MCS+ blood cell separators was 1.83% (518/28 351), which was higher than that of 1.41% (219/15 482) of Amicus and 0.82% (163/19 949) of Trima Accel blood cell separators, and the differences were statistically significant (χ2=239.10, P<0.001; χ2=162.15, P<0.001). ② Among the 900 sets of scrapping apheresis platelets consumables of this study, the scrapping rate due to collection factors was 1.16% (738/63 782), which was higher than that of 0.25% (162/63 782) due to consumables factors, and the difference was statistically significant (χ2=304.28, P<0.001). Among the 738 sets of scrapping apheresis platelets consumables due to collection factors, the scrapping rate of MCS+ blood cell separators was 1.61% (456/28 351), which was higher than that of 0.96% (148/15 482) of Amicus and 0.67% (134/19 949) of Trima Accel blood cell separators, and the differences were statistically significant (χ2=220.79, P<0.001; χ2=164.42, P<0.001). Among the 162 sets of scrapping apheresis platelets consumables due to consumables factors, the scrapping rate of Amicus blood cell separators was 0.46% (71/15 482), which was higher than of 0.22% (62/28 351) of MCS+ and 0.15% (29/19 949) of Trima Accel blood cell separators, and the differences were statistically significant (χ2=19.05, P<0.001; χ2=30.38, P<0.001). ③ Among the 738 sets of scrapping apheresis platelets consumables due to collection factors, venipuncture failure (0.38%, 241/63 782), machine fault (0.23%, 144/63 782) and chyle blood (0.21%, 133/63 782) were main scrapping reasons. Conclusions There are differences in the scrapping rate and reasons of apheresis platele consumables scrapping of 3 types of blood cell separators used in Chengdu Blood Center. The reasons for scrapping are mainly the collection factors, including venipuncture failure, machine failure and chyle blood. In the work of apheresis platelets collection, the appropriate blood cell separators and matching apheresis platelets consumables, should be selected according to the physical conditions of the blood donors, as well as the characteristics of the blood cell separators. Key words: Blood platelets; Blood safety; Apheresis platelets; Blood cell separators; Blood scrap

Analysis of causes of unqualification in primary blood screening among voluntary blood donors of apheresis platelets in Chengdu

Objective To analyze the causes of unqualification in primary blood screening among voluntary blood donors of apheresis platelets in Chengdu Blood Center. Methods A total of 36 127 cases of voluntary blood donors who participated in apheresis platelets donation in Chengdu Blood Center from January to December 2017 were selected as study objects. Age of blood donors was (32.4±7.7) years. Male and female blood donors were 26 423 and 9 704 cases, respectively. Before donation of apheresis platelets, about 4 mL of whole blood was taken from the elbow vein of each blood donor, and these whole blood samples were used for the inspection of primary blood screening. Inspection items of primary blood screening included alanine transaminase (ALT) value, platelet count, hematocrit (HCT), white blood cell count (WBC), hemoglobin (Hb) value, chylemia and hepatitis B virus surface antigen (HBsAg) expression. Then, qualification situations for primary blood screening of apheresis platelets donors were assessed according to Technical Operation Procedure for Blood Stations (2015 Edition). Total unqualified rate of primary blood screening in all apheresis platelets donors, and unqualified rates of each inspection item were counted, respectively. Chi-square test was used to compare the unqualified rates of each inspection item of all blood donors, as well as the unqualified rates between the male and female blood donors. The procedures followed in this study were in line with the requirements of the revised Declaration of Helsinki of World Medical Association in 2013. And all blood donors signed Informed Consent of Blood Donors before blood donating. Results ① In this study, among the 36 127 blood donors who participated in apheresis platelets donation in Chengdu Blood Center in 2017, 19 323 cases were unqualified in primary blood screening, and the total unqualified rate of primary blood screening was 53.49%. ② Among the 19 323 cases of apheresis platelets donors who were unqualified in primary blood screening, the unqualified rates of the primary blood screening items from high to low were 15.82% in unqualification of HCT, 15.45% in unqualification of platelet count, 9.72% in unqualification of ALT value, 7.60% in unqualification of WBC, 3.96% in unqualification of chylemia, 0.80% in unqualification of Hb value, and 0.17% in unqualification of HBsAg. Overall comparison of the unqualified rates of each inspection item of primary blood screening, the difference was statistically significant (χ2=12 724.350, P<0.001). The main causes of unqualification in primary blood screening among apheresis platelets donors were decrease of HCT, increase of ALT value, and decrease of platelet count. The proportion of unqualified blood donors with these three causes accounted for 76.63%(14 806/19 323) of the total unqualified blood donors. ③ Among the 19 323 cases of apheresis platelets donors who were unqualified in primary blood screening, the unqualified rate of male blood donors was 40.44% (10 689/26 423), which was lower than 89.01% (8 638/9 704) of female blood donors, and the difference was statistically significant (χ2=6 731.805, P<0.001). Of which, the unqualified rates of ALT value (10.63%) and platelet count (15.96%) of male blood donors were higher than those of 7.23% and 14.04% in female donors, respectively; the unqualified rates of HCT (2.97%), Hb value (0.12%), WBC (7.14%) and chylemia (3.44%) of male blood donors were lower than those of 50.80%, 2.61%, 8.83% and 5.37% in female blood donors, respectively; and all the differences in above inspection items of primary blood screening between male and female blood donors had statistical significance (χ2=77.930, 20.199, 12 194.302, 564.119, 28.879, 81.479; P<0.001). Conclusions The main causes of unqualification in primary blood screening among apheresis platelets donors in Chengdu include decrease of HCT, increase of ALT value, and decrease of platelet count. Unqualification of male blood donors are mainly due to increase of ALT value and decrease of platelet count. The majority unqualification of female blood donors is decrease of HCT. Therefore, according to the causes of unqualification in primary blood screening among different apheresis platelets donation populations, the corresponding intervention recruitment strategy should be taken to improve the qualification rate in primary blood screening among apheresis platelets donors. Key words: Voluntary blood donor; Apheresis platelets; Alanine transaminase; Plantlet count; Hematocrit; Primary blood screening, unqualification; Causes analysis; Recruitment strategy, voluntary blood donors

Should Apheresis Be Used First- or Second-Line in Neuromyelitis Optica?

Treatment of acute exacerbations of neuromyelitis optica (NMO) typically consists of intravenous methylprednisolone, apheresis therapy (plasmapheresis

Application of marketing strategies and methods in recruitment of voluntary apheresis platelet donors

Objective To explore the application of marketing strategies and methods in recruitment of voluntary apheresis platelet donors. Methods From November 2016 to October 2017, a total of 2 762 voluntary blood donors, who had donated apheresis platelet at the Foshan Central Blood Station, were included in study group. During that period, the marketing strategies and methods already applied to recruitment of voluntary apheresis platelet donors. And from November 2015 to October 2016, a total of 2 621 voluntary blood donors, who had donated apheresis platelet at the same blood station, were included in control group. During that period, the marketing strategies and methods were not applied to recruitment of voluntary apheresis platelet donors yet. Marketing strategies and methods for the recruitment of voluntary apheresis platelet donors included: mobilization of apheresis platelet donation population, optimization of blood donation environment, improvement of blood donation service mode, improvement of blood collection techniques and service levels of blood collection staff, adjustment of blood donation souvenirs, improvement of post-donation services, etc.. A retrospective analysis method was used to investigate the incidences of adverse reactions of voluntary apheresis platelet donors, the proportions of voluntary blood donors who repeatedly donated apheresis platelet more than twice in one year, and proportions of voluntary blood donors who donated 20 U of apheresis platelet at a single blood donation in the two groups, respectively. By the way of questionnaire, the satisfactions of blood donation of voluntary apheresis platelet donors in the two groups were investigated. By chi-square test and correction for continuity chi-square test, the incidences of adverse reactions of voluntary apheresis platelet donors, the proportions of voluntary blood donors who repeatedly donated apheresis platelet, the proportions of voluntary blood donors who donated 20 U of apheresis in a single blood donation, and satisfactions of blood donation of voluntary apheresis platelet donors between study and control group were compared, respectively. Results ① In this study, the incidence of adverse reactions of voluntary apheresis platelet donors in the study group was 0.4% (11/2 762), which was lower than 0.9% (24/2 621) in the control group, and the difference was statistically significant (χ2=5.574, P=0.018). ② The proportion of voluntary blood donors who repeatedly donated apheresis platelet in the study group was 16.6% (458/2 762), which was higher than 12.0% (314/2 621) in the control group, and the difference was statistically significant (χ2=17.074, P<0.001). Among the voluntary blood donors in the control group, the proportion of donors who donated twice and three times or more was 5.6% and 11.0%, respectively, which were higher than 2.8% and 9.2% in the control groups, with statistically differences (χ2=25.116, 4.863; P<0.001, =0.027). To compare the composition ratios of voluntary apheresis platelet donors who donated twice and three times or more in the two groups, there was statistically significant difference (χ2=9.055, P=0.003). ③ The proportion of blood donors who donated 20 U apheresis platelet was 21.1% (584/2 762) in study group, which was higher than 8.0% (210/262 1) in control group, and the difference was statistically significant (χ2=184.43, P<0.001). ④ The total satisfaction of blood donation of voluntary apheresis platelet donors in study group was 95.0% (114/120), was higher than 85.0% (102/120) in control group , and the difference was statistically significant (χ2=6.667, P=0.010). The composition ratio of the different degree of satisfactions of voluntary apheresis platelet donors between the two groups were compared, and there was statistically significant difference (χ2=8.682, P=0.034). Conclusions The marketing strategies and methods were applied in the recruitment of voluntary apheresis platelet donors, which could reduce the incidence and severity of adverse reactions of apheresis platelet donation, and increase number of voluntary apheresis platelet donors and satisfaction of apheresis platelet donation. So, the blood collection and supply institutions can not only develop the potential apheresis platelet donors, but also increase the number of apheresis platelet donors who could donate twice or more, which ensures continuous and healthy development of apheresis platelets donation, as well as adequate supply of apheresis platelets in clinical. Key words: Blood donors; Marketing; Blood platelets; Blood donation team; Recruiting

Application of apheresis autologous red blood cell transfusion in total hip arthroplasty

Objective To investigate the application of apheresis autologous red blood cell transfusion technology in total hip arthroplasty (THA). Methods From February to July 2016, a total of 191 patients who received THA treatment in the Chinese PLA General Hospital were selected as the research subjects. All patients were randomly divided into study group (n=91) and control group (n=100) by simple random sampling method. Patients in the study group received autologous red blood cell apheresis before THA, while the control group did not collect any autologous blood before THA. The main blood indicators, including red blood cell count, levels of hemoglobin (Hb), white blood cell count, platelet count, were recorded before apheresis in study group or before THA in control group, as well as on the 1st and 3rd day after THA in the 2 groups, respectively. The amount of blood loss during THA, allogeneic transfusion volume on the day of THA, allogeneic blood transfusion rate, allogeneic red blood cell transfusion volume, allogeneic red blood cell transfusion rate, allogeneic plasma transfusion volume, and allogeneic plasma transfusion rate were also observed. Mann-Whitney U test, Wilcoxon signed rank test or χ2 test were used to compare the difference of the above indications between the patients of 2 groups. The procedure of this study is in accordance with the requirements of the revised World Medical Association Declaration of Helsinki in 2013. Informed consent was obtained from each patient. Results ① In this study, there were no statistically significant differences in median red blood cell count of patients between study group before apheresis and that of control group before THA, as well as those of patients between the 2 groups on the 1st and 3rd day after THA (P>0.05). In study group, the median red blood cell count of patients before apheresis was higher than that of patients on the 1st and 3rd day after THA, and the differences were statistically significant (4.5×1012/L vs 4.1×1012/L, Z=-4.043, P 0.05). On the 1st day after THA, the median Hb level of patients in study group was 125 g/L (113-134 g/L), which was higher than 115 g/L (107-135 g/L) of patients in control group, and the difference was statistically significant (Z=-2.302, P=0.021). In study group, the median Hb level of patients before apheresis was higher than those of patients on the 1st and 3rd day after THA, and the differences were statistically significant (137 g/L vs 125 g/L, Z=-6.668, P 0.05). On the 1st day after THA, the median white blood cell count of patients in study group was 11.34×109/L (9.75×109/L-12.76×109/L), which was higher than 10.20×109/L (8.50×109/L-12.39×109/L) in control group, and the difference was statistically significant (Z=-2.399, P=0.016). In study group, the median white blood cell count of patients on the 1st day after THA was higher than those of patients before THA and on the 3rd day after THA, and the differences were statistically significant (11.34×109/L vs 6.15×109/L, Z=-8.272, P 0.05). In study group, the median platelet count of patients before apheresis was higher than those of patients on the 1st and 3rd day after THA, and the differences were statistically significant (229×109/L vs 183×109/L, Z=-7.796, P 0.05). The median volume of allogeneic blood transfusion of patients in study group was 2.6 U (1.0-4.4 U), which was lower than 5.3 U (3.0-7.2 U) of patients in control group, and the difference was statistically significant (Z=-3.903, P 0.05). The rate of allogenic red blood cell transfusion of patients in study group was 52.7%, which was lower than 82.0% of patients in control group, with a statistically significant difference (χ2=18.756, P<0.001). Conclusions The apheresis autologous red blood cell transfusion could meet the needs of clinical blood transfusion in patients with THA, which is safe and effective, and could be promoted during surgery. Key words: Blood transfusion, autologous; Arthroplasty, replacement, hip; Blood component transfusion; Apheresis autologous red blood cell; Autologous blood

Expected outcome of patients with acute renal failure and severe sepsis and multi organ dysfunction with focus on apheresis

Expected outcome of patients with acute renal failure and severe sepsis and multi organ dysfunction with focus on apheresis

The commentaries of plasma exchange therapy for neuromyelitis optica related optic neuritis

Plasma exchange (PE) is a therapeutic blood component replacement method. The blood of patients is first separated into plasma and blood cell components using a blood cell separator in vitro, the plasma containing harmful pathogenic substances is then discarded and replaced with the same volume of exchange solution. Finally the separated blood cells together with the exchange solution are returned back to the blood circulation of patients. By reducing the circulating antibodies, abnormal plasma proteins or cytokines and other pathogenic molecules, PE can block the disease process. PE has a good therapeutic effect on neuromyelitis optica-related optic neuritis (NMO-ON), which shows resistant to glucocorticoid therapy for the first onset. The American Society for Apheresis guideline evaluates PE for acute optic neuritis as a recommended grade 1B, type II indication. In the implementation of PE treatment for NMO-ON and other diseases, indications and contraindications should be strictly adhered to the guideline, treatment procedures and protocols should be optimized, common adverse events and its prevention and management should be known and alerted. It is important to conduct multi-center clinical cooperation and a high standard clinical randomized controlled study, to find out the optimal time window, the best protocol, and the associated factors for the efficacy and prognosis of PE in NMO-ON. Key words: Neuromyelitis optica/therapy; Optic neuritis/therapy; Plasma Exchange; Editorial

Clinical effects among different strategies of autologous blood transfusion

Objective To investigate effectiveness of different strategies of autologous blood transfusion, in order to promote development of autologous blood transfusion in medical institutions, and to ensure the safety of clinical transfusion. Methods From January 2014 to July 2016, a total of 88 patients undergoing orthopedic surgery who received autologous blood transfusion in General Hospital of Beijing Military Region or Dalian Municipal Central Hospital, were randomly selected as research objects by simple random sampling method. A simple random grouping method was used to classify the patients into intraoperative salvaged autotransfusion group (n=43), stored autologous whole blood transfusion group (n=25), and stored autologous red blood cells transfusion group (n=20). A total of 42 patients undergoing orthopaedic surgery who received allogeneic blood transfusion were randomly selected from above hospital during the same period by simple random sampling method, and they were included in control group (n=42). The data including patients′ red blood cell count, hemoglobin (Hb) level, hematocrit (HCT) and platelet count were collected and analyzed in different time points which were before blood collection/surgery, the first day after blood transfusion, the fourth day after blood transfusion. And days of hospitalization, volume of bleeding in the operation, infusion volume of allogeneic blood in each group were also collected and analyzed. Statistical methods were used to compare the differences of the above indexes among 4 groups. Results ① There were no statistically significant differences in red blood cell count, Hb level, HCT, platelet count among patients of 4 groups before blood collection/surgery (P>0.05). ② There were no statistically significant difference in red blood cell count, Hb level, HCT among patients of 4 groups on the first day after blood transfusion. But there was significant differences in platelet count among 4 groups (F=4.157, P=0.008). And platelet count of patients in stored autologous whole blood transfusion group was the highest, as (196.0±43.80)×109/L. Among them, compared with control and intraoperative salvaged autotransfusion groups respectively, the differences were statistically significant (P=0.004, 0.009). However, compared with stored autologous red blood cells transfusion group, the difference was not statistically significant (P=0.653). ③ There was no statistically significant difference in red blood cell count of patients in 4 groups on the fourth days after blood transfusion (P>0.05). Comparison of Hb level in 4 groups, the difference was statistically significant (F=3.764, P=0.013). Hb level of patients in intraoperative salvaged autotransfusion group was the highest [(115.6±23.8) g/L], which compared with stored autologous transfusion and control groups respectively, the differences were statistically significant (P=0.006, 0.022), but there was no statistically significant that compared with preoperative autologous red blood cells group (P=0.878). Comparison of HCT in these 4 groups, the difference was statistically significant (F=3.915, P=0.011). The HCT of patients in the stored autologous red blood cells transfusion group was the highest [(34.4±4.8)%] among 4 groups, which compared with control group, the difference was statistically significant (P=0.012); but compared with stored autologous whole blood transfusion and intraoperative salvaged autotransfusion groups respectively, the differences were not statistically significant (P=0.059, 0.819). ④ There were no statistically differences observed in bleeding volume and allogeneic blood transfusion volume in the operation among 4 groups (P>0.05). Hospitalization days were compared, and the difference was statistically significant (χ2=11.990, P=0.007). Among them, patients in control group had the highest hospitalization days [14.5 d(9.5-16.0 d)], which compared with stored autologous whole blood transfusion group, the difference was statistically significant (P=0.007); compared with stored autologous red blood cells transfusion and intraoperative salvaged autotransfusion group respectively, the differences were not statistically significant (P=0.09, 0.944). Conclusions For the selection of auto logous blood infusion strategies in patients undergoing elective surgery in clinical, preferred to use stored autologous red blood cells transfusion, followed by stored autologous whole blood transfusion and intraoperative salvaged autotransfusion. When autologous blood transfusion is not available, allogeneic blood transfusion could be used. Therefore, clinicians need to change their ideas to reduce the rate of allogeneic blood transfusion gradually, and to develop the autologous blood transfusion extensively and effectively, so as to ensure the safety of clinical blood transfusion. Key words: Blood transfusion, autologous; Blood component transfusion; Apheresis red blood cells; Allogeneic transfusion

Investigation on apheresis platelet donors in Chengdu from 2010 to 2015

Objective To investigate the current situation and trend of apheresis platelet donation in Chengdu from 2010 to 2015, in order to provide scientific bases for apheresis platelet collection plan, apheresis platelet donors enrollment plans and guidance of blood transfusion. Methods From 2010 to 2015, a total of 73 106 donors who donated apheresis platelet in Chengdu Blood Center were selected as research subjects. The information management system of blood bank was used to collect apheresis platelet donors′ information including age, gender, and number of blood donation. The speeds of development and increase were used to describe the developing trend of apheresis platelet donors in Chengdu form 2010 to 2015, and statistical methods were used to compare the differences of composition ratios of different genders and ages of apheresis platelet donors form 2010 to 2015. Results ① From 2010 to 2015, the number of apheresis platelet donation in Chengdu increased from 6 798 cases to 17 684 cases, with an absolute increase of 10 866 cases, and an annual average increase of 2 173 cases, and the annual average increase rate was 21.1%. From 2010 to 2015, the link growth rate of each year was 22.4%, 28.4%, 31.1%, 11.6% and 13.2% respectively, among which the link growth rates in 2012 and 2013 were higher than those in other years. ② From 2010 to 2015, among the apheresis platelet donors in Chengdu, male apheresis platelet donors (72.02%, 52 650/73 106) were more than female (27.98%, 20 456/73 106), and the proportions of male donors were all more than 60% in each year. Among them, proportion of male donors was the highest in 2014, accounted for 76.88% (12 010/15 622). There was significant difference of gender ratios of apheresis platelet donors from 2010 to 2015 (χ2=691.483, P 25-30 years old and >30-35 years old groups increased gradually. From 2012, blood donors with the age of >55-60 years old participated in apheresis donation team, the proportions of each year from 2012 to 2015 were 0.46% (49/4 561), 1.09% (153/14 002), 1.42% (222/15 622) and 1.19% (210/17 684), respectively. There was significant difference of age composition ratios of apheresis platelet donors from 2010 to 2015 (χ2=2 542.556, P<0.001). Conclusions The apheresis platelet donation increases year by year in Chengdu from 2010 to 2015. In each year, male apheresis platelet donors are more than female and 18-25 years old apheresis platelet donors are the main apheresis platelet donors Based on the characteristics of apheresis platelet donation in Chengdu, scientific apheresis platelet collection plan and apheresis platelet donors recruitment program should be established, in order to ensure the provision of adequate and safe apheresis platelet for clinic. Key words: Blood platelets; Blood donor; Investigation