Apheresis Unit Research Articles

Effectiveness and safety of therapeutic plasma exchange in neurological diseases: An 11-year report from a tertiary care center.

Therapeutic plasma exchange has been a well-known treatment method for many years and is widely available. It leads to the improvement of neurological symptoms in autoimmune neurological diseases by the removal of antibodies. The aim of this study was to present therapeutic plasma exchange responses and procedure-related adverse events in patients with autoimmune neurological diseases based on our 11-year experience. A retrospective evaluation was conducted on adult patients who underwent a therapeutic plasma exchange procedure due to neurological diseases between January 2013 and January 2024. Data were gathered from electronic and written hospital and apheresis unit records. A total of 265 patients underwent 1274 procedures with a preliminary diagnosis of autoimmune neurological disease. Five patients were excluded from the analysis due to their final diagnoses. The most common clinical indications were Guillain-Barré syndrome (45.4%), myasthenia gravis (26.1%), and multiple sclerosis (19.2%). The overall response rate was 81.3%, with 21.7% exhibiting a complete response and 59.6% demonstrating a partial response. With the exception of one patient (hypertensive crisis), no complications necessitating the termination of the procedure were observed. The most prevalent complication was an easily manageable allergic reaction. Therapeutic plasma exchange has been demonstrated to be an efficacious and safe treatment option in autoimmune neurological diseases, with a favorable overall response rate and a manageable mild-to-moderate side effect profile.

Implementation of Ultrasound-Guided Cannulation Training Across Eight NHSBT Therapeutic Apheresis Units in England.

Ultrasound-guided cannulation (USGC) of a peripheral vein reduces the need for central vascular access device (CVAD) placement to perform a successful apheresis procedure. Effective training of healthcare professionals to acquire this skill is essential. Here, we report on the implementation of the USGC training across eight apheresis units in England. A 3-h introductory training program was devised with theoretical and practical elements. This was followed by supervised USGC practices on any patient ≥ 18 years old, regardless of venous status. Data on all supervised USGC attempts were recorded and analyzed. Over an 11-month period, 11 nurses were trained to USGC competency with another six nurses still in training, resulting in seven out of eight units having at least one USGC-competent nurse. In one unit, USGC training has not started yet. Three hundred sixty-one supervised USGC episodes on 168patients and donors took place; of these, 178 were done for training purposes only on patients who had visible and palpable veins, 179 USGC were done on patients with difficult venous status and four were not recorded. The period from first supervised USGC to competency was a median of 45 days (Range: 17-166 days), with a median of 15 successful (Range: 10-30) and two unsuccessful (Range: 1-15) USGC being performed per trainee. The placement of 57 CVADs and 41 multiple cannulation attempts have been avoided. USGC is a useful tool to reduce the need for CVAD. Training across multiple apheresis units is a lengthy procedure, but it can be successfully implemented.

Comparable bacterial growth in platelet concentrates suspended in plasma and platelet additive solution and improved detection of bacterial contamination using a new generation automated culture system.

Microbial screening of platelet concentrates (PC) with automated culture methods is widely implemented to reduce septic transfusion reactions. Herein, detection of bacterial contamination in PC was compared between units prepared in plasma and a mix of plasma and platelet additive solution (PAS) and between the BACT/ALERT 3D and next generation BACT/ALERT VIRTUO systems. Double apheresis units were split into single units, diluted in either PAS (PAS-PC) or plasma (plasma-PC), and tested for in vitro quality and sterility prior to spiking with ~30 CFU/unit of Staphylococcus epidermidis, Staphylococcus aureus, Serratia marcescens, and Klebsiella pneumoniae or ~10 CFU/mL of Cutibacterium acnes. Spiked PC were sampled for BACT/ALERT testing (36 and 48 h post-spiking) and colony counts (24, 36, and 48 h post-spiking). Times to detection (TtoD) and bacterial loads were compared between PC products and BACT/ALERT systems (N = 3). Bacterial growth was similar in plasma-PC and PAS-PC. No significant differences in TtoD were observed between plasma-PC and PAS-PC at the 36-h sampling time except for S. epidermidis which grew faster in plasma-PC and C. acnes which was detected earlier in PAS-PC (p < .05). Detection of facultative bacteria was 1.3-2.2 h sooner in VIRTUO compared with 3D (p < .05) while TtoD for C. acnes was not significantly different between the two systems. Comparable bacterial detection was observed in plasma-PC and PAS-PC with PC sampling performed at 36-h post blood collection. PC sampling at ≤36 h could result in faster detection of facultative pathogenic organisms with the VIRTUO system and improved PC safety.

Bacterial Contamination of Platelet Products.

Transfusion of bacterially contaminated platelets, although rare, is still a major cause of mortality and morbidity despite the introduction of many methods to limit this over the past 20 years. The methods used include improved donor skin disinfection, diversion of the first part of donations, use of apheresis platelet units rather than whole-blood derived pools, primary and secondary testing by culture or rapid test, and use of pathogen reduction. Primary culture has been in use the US since 2004, using culture 24 h after collection of volumes of 4-8 mL from apheresis collections and whole-blood derived pools inoculated into aerobic culture bottles, with limited use of secondary testing by culture or rapid test to extend shelf-life from 5 to 7 days. Primary culture was introduced in the UK in 2011 using a "large-volume, delayed sampling" (LVDS) protocol requiring culture 36-48 h after collection of volumes of 16 mL from split apheresis units and whole-blood derived pools, inoculated into aerobic and anaerobic culture bottles (8 mL each), with a shelf-life of 7 days. Pathogen reduction using amotosalen has been in use in Europe since 2002, and was approved for use in the US in 2014. In the US, recent FDA guidance, effective October 2021, recommended several strategies to limit bacterial contamination of platelet products, including pathogen reduction, variants of the UK LVDS method and several two-step strategies, with shelf-life ranging from 3 to 7 days. The issues associated with bacterial contamination and these strategies are discussed in this review.

Clocking the Processes and Challenges of Urgent Red Blood Cell Exchange for Acute Complications of Sickle Cell Disease

Background: Red blood cell exchange transfusion (RBCX) is the therapy of choice for some acute complications of sickle cell disease (SCD), including stroke, severe acute chest syndrome and multi-organ failure. Rapid initiation of RBCX is critical to reduce morbidity and mortality in those with acute complications of SCD. A typical RBCX procedure requires anywhere from 6-10 units of packed red blood cells (RBC) and measures are taken to provide higher-fidelity RBC matches (key RHCE and KEL antigens at a minimum, ±suitable KIDD, FY, Ss profiles for the sensitized). Our recent review of urgent apheresis transfers to our tertiary-care centre, including 26 for RBCX, demonstrated that the median time per transfer was approximately 4 hours. Not yet characterized is the additional time required to start RBCX once a patient arrives. The time required to investigate antibody repertoires, and to procure sufficient quantities of blood that can bypass these specificities, is of interest in a specialty center with substantial but not unlimited investigative expertise and inventory. Methods: This was a retrospective database and chart review of all patients referred to our apheresis service for urgent RBCX for severe complications of SCD between Jan 1, 2013 to Dec 31, 2020. Time stamps for admission, blood bank, and apheresis processes were extracted from the electronic medical record and blood bank database. Categorical variables were analyzed using nonparametric tests. Results: Thirty-eight patients were included (65.8% males, 35.2% females) (Table 1). HbSS was the most common SCD genotype represented (81.6%). Most patients (71.1%) were transferred from another hospital, with the remaining patients arriving through the emergency department (26.3%) and one (2.6%) as a direct admission from clinic. ACS +/- additional complications constituted the most common indication for RBCX (78.9%). Two patients died due to complications of multi-organ failure, the remaining patients were discharged from hospital. Six patients (15.8%) had a positive antibody screen. The majority had RBC phenotype (42.1%) or genotype +/- phenotype (36.8%) on file to facilitate extended matching, and sufficient appropriate units were available in the blood bank in 82% of cases. Four (10.5%) patients required top-up transfusions prior to RBCX due to significant anemia. The median number of units issued per procedure was 9 (IQR 2). The median times from index group and screen (G&amp;S) collection to sample accession, and from accession to result were 23 minutes (IQR 26) and 46 minutes (IQR 31), respectively (Figure 1). The median time from G&amp;S result to RBC units issued was 348.5 minutes (IQR 479). The median total time from patient admission (or determination of RBCX indication) to RBC units issued was 569 minutes (IQR 464). A positive antibody screen, patient origin (ED vs. transfer), and the availability of sufficient RBC units in house were associated with turnaround time from accession of the index G&amp;S sample to the issuing of RBCs (p&amp;lt;0.01 for all). Patients having antibodies to high prevalence antigens (e.g. anti-U) or to multiple targets (demanding unique donor profiles) had some of the longest times to initiate treatment. These constraints necessitated orders and coordinated deliveries of units from across the geographic network of the national blood provider.Discussion: These data from the largest apheresis unit in the country characterize the time invested in blood preparation for an urgent RBCX for acute SCD complications. A positive antibody screen is predictive of increased time to procedure start, reflecting delays inherent to serologic investigations, product sourcing, and serologic crossmatch times. While the precise moment of a blood request was available for a minority of patients, the G&amp;S time stamp was used as a surrogate, thus potentially overestimating turnaround times in the blood bank. Nevertheless, the serologic demands inherent to a case present a tension between speed (treating the disease) and safety (averting immune rejection reactions).

Comorbidity in lipoprotein apheresis: Their role in the era of new lipid-lowering therapies.

Despite advance in pharmacotherapy of lipid disorders, lipoprotein apheresis (LA) plays a leading role in the management of severe hypercholesterolemia and in atherosclerosis prevention. Aim of this study was to retrospectively evaluate Charlson Comorbidity Index (CCI), presence of major comorbidity, and/or concomitant polypharmacy (definite as 5+ drugs daily) in patients with inherited dyslipidemias on chronic LA. Since 1994, we performed more than 500 LA treatment/year and followed a total of 83 patients (age 56 [47-65] years, male 75%). In subjects with more than 5 years of LA treatment (38 patients, age 54 [45-62] years, male 66%), at the end of the observation time (9 [7-16] years), patients had higher CCI, polypharmacy, anemia, heart failure, peptic ulcer disease, and benign prostatic hyperplasia. Even in the era of new lipid-lowering therapies, the LA treatment established itself as a safe and lifesaving intervention. Patients on chronic LA require a multidisciplinary approach to address their comorbidity and the apheresis unit's medical staff (doctors and nurses) play a pivotal role creating a bridge toward the general practitioner and other specialists for overcoming clinical issues.

P‐BB‐34 | Establishing a Platelet Apheresis Unit in Zambia a Resource Restricted Country

P‐BB‐34 | Establishing a Platelet Apheresis Unit in Zambia a Resource Restricted Country

Therapeutic Plasma Exchange in Adult Patients with COVID-19 and Severe Pneumonia: Single Center Experience of Eighty Patients

Aim: Therapeutic plasma exchange (TPE) is a frequently discussed treatment modality in severe coronavirus disease 2019 (COVID-19) patients. It requires an apheresis device and experienced personnel for the application. In this study, we aimed to reveal the characteristics and clinical outcomes of adult patients with COVID-19 who experienced TPE. Material and Methods: Adult patients who had undergone TPE in our apheresis unit were retrospectively analyzed and COVID-19-positive cases were included in the study. All the medical information about the cases was obtained from the electronic database and technical details of the procedures were gathered from apheresis unit records. Results: A total of 80 patients with a median age of 60 (19-85) years were included in the study. Severe pneumonia was present in 98.8% (n=79) of the cases. More than three-quarters of the patients had lymphopenia, critically elevated C-reactive protein (CRP), and D-dimer, and 41.0% (n=32) had high ferritin. The median length of stay in the intensive care unit was 26 (5-124) days. The mortality rate observed on the 14th and 28th days following the TPE procedure was 51.3% (n=41) and 75.0% (n=60), respectively. High ferritin level, multiple organ failure (MOF), and intubation were parameters found to be associated with mortality in the multivariate analysis. Conclusion: The mortality rate observed in patients with COVID-19 who underwent TPE in our study was similar to the cases in the literature without the procedure, while it has been shown that high ferritin levels, intubation, and the presence of MOF increase the risk of mortality.

Retrospective comparison of two different cell separators for autologous peripheral blood stem cell collection: Single center experience

IntroductionAutologous peripheral blood stem cell (PBSC) transplantation has become a standard treatment option for certain hematological malignancies. The collection of PBSCs for transplantation is a well-established process and the effectiveness can vary depending on the cell separator. We aimed to compare the effectivity of two devices, the Spectra Optia and the Amicus for autologous PBSC collection. We also evaluated the effect of the peripheral white blood cell (WBC) count on the CD34+ collection efficiency (CE2). MethodsWe retrospectively evaluated 262 apheresis procedures performed in patients between 2015 and 2021 at the Apheresis Unit of our transplantation center. The PBSCs were collected by the Spectra Optia cell separator with continuous Mononuclear Collection (cMNC) (128 procedures) or the Amicus (MNC) (134 procedures). In addition to the apheresis parameters and product characteristics, we also evaluated the effect of the pre-apheresis peripheral WBC count on the CE2. ResultsThere was no significant difference in the CD34+ CE2 between the Spectra Optia and Amicus devices (median 65.06% and 68.24%, respectively, p = 0.070). In the Amicus group, the CE2 ratio was found to be statistically significantly higher in patients with a pre-apheresis peripheral WBC count of 15 × 109/L (median 81.70%, 68.06%, 61.35% and 58.13%, respectively, p < 0.001). ConclusionWhile both devices collected autologous PBSC effectively and safely, the Amicus provided a higher rate of CE2 at low pre-apheresis WBC counts. To our knowledge, this is the first study to evaluate the CE2 in autologous PBSC collection devices based on pre-apheresis WBC counts.

Managing leukapheresis in adult and pediatric patients eligible for chimeric antigen receptor T-cell therapy: suggestions from an Italian Expert Panel.

Chimeric antigen receptor (CAR) T-cell therapy relies on T cells engineered to target specific tumor antigens such as CD-19 in B-cell malignancies. In this setting, the commercially available products have offered a potential long-term cure for both pediatric and adult patients. Yet manufacturing CAR T cells is a cumbersome, multistep process, the success of which strictly depends on the characteristics of the starting material, i.e., lymphocyte collection yield and composition. These, in turn, might be affected by patient factors such as age, performance status, comorbidities, and previous therapies. Ideally, CAR T-cell therapies are a one-off treatment; therefore, optimization and the possible standardization of the leukapheresis procedure is critical, also in view of the novel CAR T cells currently under investigation for hematological malignancies and solid tumors. The most recent Best Practice recommendations for the management of children and adults undergoing CAR T-cell therapy provide a comprehensive guide to their use. However, their application in local practice is not straightforward and some grey areas remain. An Italian Expert Panel of apheresis specialists and hematologists from the centers authorized to administer CAR T-cell therapy took part in a detailed discussion on the following: 1) pre-apheresis patient evaluation; 2) management of the leukapheresis procedure, also in special situations represented by low lymphocyte count, peripheral blastosis, pediatric population <25 kg, and the COVID-19 outbreak; and 3) release and cryopreservation of the apheresis unit. This article presents some of the important challenges that must be faced to optimize the leukapheresis procedure and offers suggestions as to how to improve it, some of which are specific to the Italian setting.

A Single Center 25-year Experience in Autologous Peripheral Blood Stem Cell Collection: A Focus on the Collection Efficiency

Background: Harvest of hematopoietic progenitor cells via leukapheresis is being used increasingly for autologous transplantation. Adequate yield of cells per kilogram body weight of recipient is required for a successful engraftment. Collection efficiency (CE) is a useful parameter to assess quality of peripheral blood stem cell (PBSC) collection program. In this study, we report a 25-year experience in a tertiary care Hospital in Italy.&#x0D; Patients and Methods: 1,026 consecutives autologous PBSC collection procedure, performed in 763 patients, from January 1996 to December 2020 were retrospectively considered. Data regarding patients, Blood Cells Separators (BCS) , apheresis procedures and PBSC products were collected in our database. In these 25 years different BCS were adopted in our Apheresis Unit (AU). In the first period (1996-1999) we used Fresenius Com. Tec, in the central period (2000-2013) we used Cobe Spectra and in the last period (2014-2020) Spectra Optia.&#x0D; Results: As regards the evaluation of patients before leukapheresis, the most significant data was the increasing number of CD34+ cells. Considering the PBSC collection procedure, there was a progressive increase in the processed blood volume with a shorter apheresis duration. Data related to the PBSC collection demonstrated an increasing CD34+ cell yield and efficiency a raise in CE that was 43% using Fresenius COM-TEC BCS, 49% using Cobe Spectra BCS and 53% using Spectra Optia BCS. .&#x0D; Conclusions: These results were observed considering a 25-year period, thus a great number of factors likely contributing to the observed results, including technological improvement of the instrumentation for leukapheresis, increased experience of the team operating in the Apheresis Unit, improved mobilization protocols, better criteria for patients’ selection. Focusing our attention on CE we observed quite satisfactory results with a median which rose from 43% to 53% with an increase of 10% in the observation period.

A novel predictive algorithm to personalize autologous T-cell harvest for chimeric antigen receptor T-cell manufacture

Background aimsThe most widely accepted starting materials for chimeric antigen receptor T-cell manufacture are autologous CD3+ T cells obtained via the process of leukapheresis, also known as T-cell harvest. As this treatment modality gains momentum and apheresis units struggle to meet demand for harvest slots, strategies to streamline this critical step are warranted. MethodsThis retrospective review of 262 T-cell harvests, with a control cohort of healthy donors, analyzed the parameters impacting CD3+ T-cell yield in adults with B-cell malignancies. The overall aim was to design a novel predictive algorithm to guide the required processed blood volume (PBV) (L) on the apheresis machine to achieve a specific CD3+ target yield. ResultsFactors associated with CD3+ T-cell yield on multivariate analysis included peripheral blood CD3+ count (natural log, ×109/L), hematocrit (HCT) and PBV with coefficients of 0.86 (95% confidence interval [CI], 0.80–0.92, P < 0.001), 1.30 (95% CI, 0.51–2.08, P = 0.001) and 0.09 (95% CI, 0.07–0.11, P < 0.001), respectively. The authors’ model, incorporating CD3+ cell count, HCT and PBV (L), with an adjusted R2 of 0.87 and root-mean-square error of 0.26 in the training dataset, was highly predictive of CD3+ cell yield in the testing dataset. An online application to estimate PBV using this algorithm can be accessed at https://cd3yield.shinyapps.io/cd3yield/. ConclusionsThe authors propose a transferrable model that incorporates clinical and laboratory variables accessible pre-harvest for use across the field of T-cell therapy. Pending further validation, such a model may be used to generate an individual leukapheresis plan and streamline the process of cell harvest, a well-recognized bottleneck in the industry.

G-CSF Mobilized Apheresis As an Alternative Source of CAR T-Cells

Background Cellular therapies are traditionally manufactured from an apheresis product collected at 'steady state' i.e. without any cytokine administered prior. We sought to evaluate the feasibility of utilising the CD34-negative fraction of recombinant human granulocyte colony stimulating factor (rhG-CSF) mobilised apheresis products for the manufacture of CAR T-cells. The effect of rhG-CSF on CAR T-cell function is largely unknown. We conducted an extensive comparison of phenotypic and functional attributes of CAR T-cells manufactured after rhG-CSF exposure (mobCAR) to those manufactured from a steady state apheresis (ssCAR), in order to test the hypothesis that rhG-CSF mobilised CAR T-cells are functionally equivalent to steady state CAR T-cells. Methods Untransduced T-cells (UTD) and CAR T-cells targeting CD33 (CART33) were manufactured using paired steady state (ss) cells and cells collected after rhG-CSF treatment (mob). On a protocol approved by the institutional review board, 4 healthy volunteers had ss cells collected from peripheral blood and cryopreserved, and later underwent an apheresis collection after 4 days of G-CSF (10ug/kg/daily) to collect and cryopreserve mob cells. CART33 were then manufactured from thawed ss and mob cells in paired expansions. Cells were activated using CD3/CD28 beads, transduced with lentiviral vector and expanded using Ex-Vivo based cell culture media (fortified with IL-7/IL-15 and human serum), and cryopreserved when mean cell volume was less than 300fL. Extensive comparisons between ssCART33 and mobCART33 were completed, including analysis by flow cytometry, CyTOF, single cell RNA sequencing (scRNAseq) and metabolomics by mass spectrometry. In vitro assays of degranulation, cytokine production and killing were performed, and in vivo function was assessed using an immunodeficient murine model after engraftment with a CD33 expressing cell line. Results Paired effector T-cells were manufactured with lower fold expansion of mobCAR [4 vs. 7 population doublings, p<0.01] though a sufficient number of mob-CAR were able to be manufactured. Mean CAR expression was higher in ssCAR though this was not statistically significant [ssCAR 78.6% (55-79%) vs. 64.7% (59-71%), p>0.05], and no significant differences in CD4/CD8 ratio were observed. In vitro degranulation, cytokine production and tumour cytolysis were comparable between ssCAR and mobCAR. Functional equivalence was also seen between ssCAR and mobCAR in mouse xenografts of an acute myeloid leukemia (AML) model, with no differences in body weight, toxicity, or mouse survival observed (Figure 1). While significant inter-donor differences in T-cell subsets by CyTOF were observed, minimal differences were seen between the ss and mob products for a given donor, and integrated analysis of scRNASeq data showed a similar transcriptomic profile for ssCAR and mobCAR cells (Figure 2). Metabolomics analysis is ongoing. Conclusions and future directions We were able to successfully manufacture CAR T-cell products from G-CSF mobilized cryopreserved apheresis products, and found comparable in vivo anti-tumor efficacy and toxicity, with no significant differences in the G-CSF exposed product by multi-omic analyses. Successful completion of this work may support the use of cryopreserved G-CSF stimulated apheresis units for cell therapy applications. This may allow for an adjunct cell therapy to hematopoietic stem-cell transplant to be manufactured from the same mobilized collection, or provide a means by which previously cryopreserved mobilized units may be utilised, noting frequently lower cumulative chemotherapy exposure in historically cryopreserved T-cells. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Improvement in Platelet Product Wastage and Reduction of Costs through Implementation of the Pan Genera Detection Test.

The aim of this study was to evaluate the effects of Pan Genera Detection (PGD) testing on reducing platelet product wastage and transfusion service costs. We conducted a retrospective cross-sectional study comparing the number of platelet apheresis units wasted before (March 2017 to February 2019) and after (March 2019 to February 2021) PGD implementation. The PGD testing was performed before transfusion on days 6 and 7. Cost analysis considered the costs of platelet units wasted ($500.00/unit) and PGD test supplies and performance (estimated $26.50 per test). Paired samples t-test was used to compare platelet wastage pre- and post-PGD implementation. The number of wasted platelet units decreased from pre-PGD (419) to post-PGD (195), representing a significant decrease in platelet wastage from 17.5% to 9.2% (P < .0001). During the post-PGD period, 366 and 133 units were tested on days 6 and 7, with 28 and 36 units discarded each day, allowing transfusion of an additional 302 platelet units. Costs from platelet wastage decreased from $209,500.00 pre-PGD to $97,500.00 post-PGD. Our results showed that PGD testing effectively reduced platelet wastage, extended platelet availability, and reduced transfusion service costs.

Impediments that Challenged Therapeutic Plasma Exchange: Experience at a Tertiary Care Hospital in Bangladesh

Therapeutic plasma exchange (TPE) is an extracorporeal blood purification technique that removes circulating antibodies, toxin and mediators from the plasma of the patients. This study was conducted to assess the safety, type and frequency of complications with regard to the indications and technical aspects of the TPE procedure performed in patients referred with different indications. A total of 127 patients’ clinical data treated with 424 TPE cycles over a period of 6 years from June 2016 to July 2022 at the apheresis unit of the Department of Transfusion Medicine, Bangabandhu Sheikh Mujib Medical University in Bangladesh, were enrolled in this retrospective observational study. The median age was 35.26 years (range 19–63) with a male predominance. The indications were mostly American Society for Apheresis (ASFA) category I (81.895%) and the most common indications were neurological indications including Guillain–Barré Syndrome (GBS) (61.41%), Myasthenia Gravis (MG) (10.24%) followed by Acute Liver Failure (7.09%). Venous access was established with the femoral vein maintaining blood flow at 70 ml/min using acid citrate-dextrose solution A (ACD-A) anticoagulant. TPE was frontline therapy in 55.91% of the patients. Human albumin was used as a replacement fluid in 88% and fresh frozen plasma in 12% of the cycles. Incidence of procedural complication was 49% (n = 206) and majority of them were mild (n = 191; 45%) with only 3% and 0.47% being moderate and severe, respectively. Mild complications were hypocalcemia (n = 127; 29.95%), anxiety (n = 109; 25.70%), restlessness (n = 68; 16.04%) and hypotension (n = 46; 10.85%) in albumin group and anxiety (n = 31; 7.31%), hypocalcemia (n = 23; 5.42%), muscle cramp (n = 23; 5.42%) in FFP group. Interestingly, complications were almost similar in albumin and FFP groups except for allergic reactions and mild reactions which were mostly manageable and preventable with continuous, cautious monitoring. Our findings suggest that TPE is a relatively safe procedure and severe complications such as hypotension and anaphylaxis is preventable through continuous and dedicated monitoring by expert personnel.

EVALUATION OF CLINICAL AND LABORATORY FINDINGS OF THERAPEUTIC PLASMAPHERESIS IN CHILDREN

Therapeutic plasmapheresis is an extracorporeal treatment method. The abnormal component of the patient's plasma is removed from the blood and replaced with the remaining blood components with a selected replacement fluid. We aimed to evaluate the demographic characteristics, procedure indications, procedure methods, differences between pre- and post-procedure laboratory parameters, and procedure-related complications of pediatric patients who underwent therapeutic plasma exchance (TPE). Pediatric patients who underwent therapeutic plasmapheresis in Adana City Training and Research Hospital between 2018-2021 were included in our study. In this period, the number of pediatric patients who underwent therapeutic plasmapheresis was 61, and the total number of procedures was 238. The data of the patients were obtained from the files of the apheresis unit and the hospital registry system by retrospective analysis. Statistical analysis of the study was made with the SPSS v20 program. 25 patients were female, 36 patients were male. Youngest patient was 6 months old and eldest was 17 years old. Patients weight range was between 5 and 104 kilograms. 191 of the procedures were TPE, 47 of them were lipid apheresis. The most common indications were hepatic failure, familial hyperlipidemia, neurological disorders, hematological disorders, sepsis with MODS and intoxications. 119 transactions were in ASFA category-1. Complications were observed on 59 (%24,8) procedures. The most common complications are; vascular access releated (obstruction) (21/59), hypotension (11/59), urticaria (7/59), technical malfunctions (7/59) and hypocalcemia (4/59). No exitus was observed due to the procedures. Therapeutic plasmapheresis procedure doesn't cause serious undesirable changes in laboratory values ​​and serious complications are rare. Therapeutic plasmapheresis can be safely applied to pediatric patients in appropriate indications by making necessary adjustments.

581 - Streamlining Documentation Systems and Providing Timely Feedback to Improve Good Documentation Practices in an Apheresis Unit

581 - Streamlining Documentation Systems and Providing Timely Feedback to Improve Good Documentation Practices in an Apheresis Unit

The 4-Year Experience with Implementation and Routine Use of Pathogen Reduction in a Brazilian Hospital.

(1) Background: We reviewed the logistics of the implementation of pathogen reduction (PR) using the INTERCEPT Blood System™ for platelets and the experience with routine use and clinical outcomes in the patient population at the Sírio-Libanês Hospital of São Paulo, Brazil. (2) Methods: Platelet concentrate (PC), including pathogen reduced (PR-PC) production, inventory management, discard rates, blood utilization, and clinical outcomes were analyzed over the 40 months before and after PR implementation. Age distribution and wastage rates were compared over the 10 months before and after approval for PR-PC to be stored for up to seven days. (3) Results: A 100% PR-PC inventory was achieved by increasing double apheresis collections and production of double doses using pools of two single apheresis units. Discard rates decreased from 6% to 3% after PR implementation and further decreased to 1.2% after seven-day storage extension for PR-PCs. The blood utilization remained stable, with no increase in component utilization. A significant decrease in adverse transfusion events was observed after the PR implementation. (4) Conclusion: Our experience demonstrates the feasibility for Brazilian blood centers to achieve a 100% PR-PC inventory. All patients at our hospital received PR-PC and showed no increase in blood component utilization and decreased rates of adverse transfusion reactions.

BLEEDING MANAGEMENT DURING DELIVERY AND POSTPARTUM PERIOD IN GLANZMANN THROMBASTHENIA: EXPERIENCES FROM TWO CASES

Glanzmann thrombasthenia (GT) is a hereditary bleeding disorder. The platelets lack αIIbβ3integrin and fail to aggregate. Pregnancy can also lead to isoantibody formation when fetal cells with β3integrins pass into the circulation of a mother lacking them; a consequence is neonatal thrombocytopenia and a high risk of mortality. We here present our experience with two GT patients, in which rFVIIa was our choice for bleeding prophylaxis and/or control during delivery and postpartum period. Case 1: A 28-year-old woman with GT was hospitalized. She was on 38th gestational week (GW). Vaginal delivery was completed with rFVIIa prophylaxis. Postpartum 5th day rFVIIa stopped. The patient discharged with a minimal vaginal bleeding. Postpartum10th day, she developed severe bleeding. GT seemed to be the only related factor. rFVIIa restarted with tranexamic acid and misoprostol. Two apheresis units of platelets were transfused. That time, rFVIIa continued 7 days. Case 2: A 26-year-old woman with GT developed hematuria on 30th GW. No urinary system pathology was found. With. rFVIIa treatment, hematuria was ceased. On 39th GW, during labor she developed massive bleeding. As urgent management, 8 random units of platelet and 5 units of packed red blood cell were transfused with local vaginal compress. rFVIIa treatment was initiated. On 10th days of rFIIa with minimal vaginal bleeding the patient was discharged from the hospital. In both of the patients, no major neonatal bleeding problem was experienced. GT patients are at risk for heavy bleeding during labor, deliver or postpartum. Platelet transfusion is simple and easy option for bleeding control. In alloimmunized patients pooled platelet should be used. The use of rFVIIa appears to be safe and relatively effective.

Acute pancreatitis due to severe hypertriglyceridemia in the COVID-19 era: The role of therapeutic plasma exchange

The psychosocial consequences of the COVID-19 pandemic caused multifaceted challenges in clinical and therapeutic practices. This was the case at the Therapeutic Apheresis Unit of the Padua University Hospital too.Several published reports describe the increase in alcohol and food addiction diseases. In this context, during the last months, the Padua Therapeutic Apheresis Unit treated many more patients with acute pancreatitis due to severe hypertriglyceridemia with therapeutic plasma exchange than in the previous ten years. Furthermore, retrospective cohort studies have been recently published describing the onset of acute pancreatitis during the COVID-19 infection even if, to date, there is still insufficient evidence to estabilish a direct causality.Anyway, the COVID-19 pandemic translated into changes of the overall disease prevalence scenario and therefore the Padua Therapeutic Apheresis Unit will need to reorganise its Therapeutic Apheresis activity.