Preemptive Approach to Plerixafor Use Is Optimal in Patients With Relapsed/Refractory Germ Cell Tumors Undergoing Peripheral Blood Hematopoietic Stem Cell Collection: Effect on Collection Days, Yields, and Cost.

Evidence describing the use of plerixafor in the off-label population of relapsed/refractory germ cell tumors (GCT) is limited. We aim to describe the effect of rescue versus preemptive plerixafor use on apheresis collection days, collection yields, and cost. We retrospectively collected data on 77 consecutive patients (at least 15 years of age) with GCT who underwent peripheral blood stem cell (PBSC) collection for autologous stem cell transplant between January 1, 2020 and May 1, 2022. Depending on insurance approval, plerixafor was given either as "rescue" (after a first apheresis collection of < 5 × 106 CD34+ cells/kg) or as "preemptive" on Day 4 of granulocyte-colony stimulating factor (G-CSF) prior to the first apheresis collection, if the Day 4 peripheral blood CD34+ count was < 40 cells/µL. A total of 66% of patients who received preemptive plerixafor completed collection in 1 day, similar to good mobilizers who only needed G-CSF (71%, p = 0.366). In contrast, all poor mobilizers in the rescue group required at least 2 days of collection and had lower CD34+ cell yields than the preemptive group (7.15 vs. 9.81 × 106/kg, p = 0.0055). A cost analysis revealed that preemptive plerixafor may save approximately $7000 per patient compared with a rescue approach. Preemptive plerixafor in GCT patients undergoing PBSC collection allows relatively poor mobilizers to collect in fewer days and with lower overall cost. Fewer apheresis procedures result in less risk to the patient, increased patient satisfaction, and the ability to schedule more patients within the constraints of staffing.

Lipoprotein apheresis and PCSK9 inhibitors for severe familial hypercholesterolaemia: Experience from Australia and New Zealand.

INTRODUCTION: Severe familial hypercholesterolaemia (FH) causes premature disability and death due to atherosclerotic cardiovascular disease and is refractory to standard lipid-lowering therapies. Lipoprotein apheresis (LA) has long been a standard of care for patients with severe FH, but is invasive, expensive and time-consuming for patients and their caregivers. Newer drug therapies, including the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, may reduce the need for LA. MATERIALS AND METHODS: We audited the records of 16 patients (eight homozygous, eight heterozygous) treated with LA in Australia and New Zealand, 14 of whom subsequently commenced PCSK9 inhibitor therapy. LA was performed by cascade filtration in all centres. RESULTS: LDL-cholesterol was acutely lowered by 69 ± 7% in patients with homozygous FH and by 72 ± 9% in those with heterozygous FH, representing time-averaged reductions of 36 ± 12% and 34 ± 5%, respectively. LA was well-tolerated, and patients reported comparable quality of life to population and disease-related norms. After commencement of PCSK9 inhibitors, four of seven patients with homozygous FH had meaningful biochemical responses, with a reduction in the frequency of LA permitted in one patient and complete cessation in another. Four of seven patients with heterozygous FH were able to be managed without LA after commencing PCSK9 inhibitors. CONCLUSION: While PCSK9 inhibitors have reduced the need for LA, some patients with severe FH continue to require LA, and will require it for the foreseeable future. However, emerging therapies, including angiopoetin-like 3 inhibitors, may further reduce the need for LA.

Current Role of Lipoprotein Apheresis.

PURPOSE OF REVIEW: Lipoprotein apheresis is a very efficient but time-consuming and expensive method of lowering levels of low-density lipoprotein cholesterol, lipoprotein(a)) and other apoB containing lipoproteins, including triglyceride-rich lipoproteins. First introduced almost 45 years ago, it has long been a therapy of "last resort" for dyslipidaemias that cannot otherwise be managed. In recent years new, very potent lipid-lowering drugs have been developed and the purpose of this review is to define the role of lipoprotein apheresis in the current setting. RECENT FINDINGS: Lipoprotein apheresis still plays an important role in managing patients with homozygous FH and some patients with other forms of hypercholesterolaemia and cardiovascular disease. In particular, patients not achieving treatment goals despite modern lipid-lowering drugs, either because these are not tolerated or the response is insufficient. Recently, lipoprotein(a) has emerged as an important cardiovascular risk factor and lipoprotein apheresis has been used to decrease lipoprotein(a) concentrations in patients with marked elevations and cardiovascular disease. However, there is considerable heterogeneity concerning the recommendations by scientific bodies as to which patient groups should be treated with lipoprotein apheresis. Lipoprotein apheresis remains an important tool for the management of patients with severe drug-resistant dyslipidaemias, especially those with homozygous FH.

New subcutaneous PowerFlow port results in cost and time-savings in a busy outpatient apheresis clinic.

Many vascular access options, such as subcutaneous ports, are currently on the market for use in both medication infusion and for procedures, such as therapeutic plasma exchange and extracorporeal photopheresis. We compared the cost and time necessary to complete apheresis procedures using either Angiodynamic's Vortex or Bard's PowerFlow subcutaneous ports by reviewing our experience on two patients undergoing long-term apheresis treatments with at least 10 procedures with each type of port. We analyzed the cost of needles and thrombolytic therapy, staff time, overall procedure length, and the total time the patient was in the apheresis unit. We also compared flow rates and alarm rates between the two ports. In this small pilot study, use of the PowerFlow port resulted in significant cost and time savings, with mixed results for flow rates. Our results need to be confirmed in a larger patient population prior to recommending wide implementation of Bard's PowerFlow port.

Comparison and cost analysis of three protocols for mobilization and apheresis of haematopoietic progenitor cells.

INTRODUCTION: Autologous bone marrow transplantation is a component of the malignant hemopathy therapy. The preferred mobilization and collection method is apheresis. The aim of this study is to compare three protocols analyzing the effect of plerixafor, higher dose of G-CSF and large volume leukapheresis (LVL). MATERIALS AND METHODS: A retrospective cohort study including 119 patients referred for mobilization. Three protocols were compared: (a) G-CSF 10 µg/kg/day subcutaneous (sc) × 4 days mobilizing 1 to 1.5 blood volumes. (b) G-CSF 10 µg/kg/day sc × 4 days + plerixafor 0.24 mg/kg/day sc preventively or as a rescue agent mobilizing 1 to 1.5 blood volumes. (c) G-CSF 20 µg/kg/day sc × 4 days ± plerixafor 0.24 mg/kg/day sc preventively or as a rescue agent mobilizing 3 to 4 blood volumes. RESULTS: The average number of days of apheresis was reduced to 1.37 with protocol 3. The average cost per patient was reduced by 67% compared with protocol 2 and increased by only 5% compared with protocol 1, reducing the failure rate to 0%. CONCLUSION: Adding preemptive or rescue plerixafor (protocol 2) to G-CSF 10 µg/kg/day alone (protocol 1) did not improve the days of apheresis nor the number of CD34+ cells collected but had higher cost and failure rate. Using LVL, plerixafor and G-CSF 20 µg/kg/day (protocol 3) decreased the number of sessions to 1.37, reduced the failure rate to 0% and led to a significant increase in the number of CD34+ cells collected without toxicity and with a similar cost to protocol 1.

Impact of plerixafor (mozobil) on hospital efficiency: A single center experience.

Plerixafor (Mozobil) in combination with granulocyte colony-stimulating factor (G-CSF) has shown to increase mobilization of peripheral blood stem cells (PBSC) as compared to G-CSF alone in patients undergoing autologous stem cell transplantation (ASCT). However, up to 25% of patients treated with G-CSF alone still fail mobilization. Adding plerixafor to poor mobilizers allows to rescue these patients from mobilization failure and to reduce the number of apheresis sessions. The goal of this retrospective study was to capture the impact of plerixafor on treatment outcome and on apheresis department efficiency. The latter was measured in terms of time-slots lost, that is, the number of apheresis sessions scheduled but not carried out due to poor mobilization, and the number of elective apheresis sessions performed for patients undergoing extracorporeal photopheresis (ECP). Hospital records of patients treated before and after introduction of plerixafor were collected and analyzed. With plerixafor, the mobilization failure rate dropped from 12% to 4% and the mean number of time-slots lost per patient dropped from 1.39 to 0.89. Additional drug costs due to plerixafor were partially balanced by a reduction in apheresis sessions, resulting in an additional cost of 759€ per ASCT candidate. More importantly, with the use of plerixafor, the availability of time-slots turned from erratic to predictable such that freed capacity could be dedicated to other apheresis procedures. As a result, the number of ECP sessions increased from 0 in 2005 to 685 sessions in 2014.

The use of a medico economic database as a part of French apheresis registry.

An apheresis registry is a part of each learned apheresis society. The interest in this is obvious, in terms of knowledge of the practice of apheresis, adverse events, and technical issues. However, because of the weight of data entry it could never be exhaustive and some data will be missing. While continuing our registry efforts and our efforts to match with other existing registries, we decided to extend the data collection to a medico-economic database that is available in France, the Programme de Médicalisation du Système d'Information (PMSI) that has covered reimbursement information for each public or private hospital since 2007. It contains almost all apheresis procedures in all apheresis fields, demographic patient data, and primary and related diagnoses, among other data. Although this data does not include technical apheresis issues or other complications of the procedures, its interest is great and it is complementary to the registry. From 2003-2014, we have recorded 250,585 apheresis procedures, for 48,428 patients. We showed that the data are reliable and exhaustive. The information shows a perfect real life practice in apheresis, regarding indications, the rhythm and the duration of apheresis treatment. This prospective data collection is sustainable and allows us to assess the impact of healthcare guidelines. Our objective is to extend the data collection and match it to other existing databases; this will allow us to conduct, for example, a cohort study specifically for ECP.

Cost analysis of a randomized stem cell mobilization study in multiple myeloma.

Upfront autologous stem cell transplantation (ASCT) is the standard therapy for younger multiple myeloma (MM) patients. MM patients usually undergo stem cell mobilization with cyclophosphamide (CY) followed by granulocyte colony-stimulating factor (G-CSF), or with G-CSF alone. A limited number of randomized studies are available comparing costs of different mobilization strategies. Eighty transplant-eligible patients aged up to 70 years with untreated MM were included in this prospective study. The patients were treated with RVD induction for three 21-day cycles and randomized 1:1 at inclusion into one of the two mobilization arms CY 2 g/m(2) + G-CSF [arm A] vs. G-CSF alone [arm B]. Plerixafor was given according to a specific algorithm if needed. Sixty-nine patients who received mobilization followed by blood graft collection were included in the cost analysis. The median total costs of the mobilization phase were significantly higher in arm A than in arm B (3855 € vs. 772 €, p ≤ 0.001). The cumulative median cost of the mobilization and collection phases was significantly lower in arm B than in arm A (8524 € vs. 11,622 €, p = 0.012). There was no significant difference between the arms in the total median costs of ASCT (n = 59) (34,997 € in arm A vs. 31,981 € in arm B, p = 0.118). Mobilization with G-CSF alone seems to be a preferable mobilization method for MM patients in terms of mobilization and apheresis costs. In addition, it requires less hospital resource utilization.

Red blood cell depletion from bone marrow and peripheral blood buffy coat: a comparison of two new and three established technologies.

BACKGROUND: Red blood cell (RBC) depletion is a standard technique for preparation of ABO-incompatible bone marrow transplants (BMTs). Density centrifugation or apheresis are used successfully at clinical scale. The advent of a bone marrow (BM) processing module for the Spectra Optia (Terumo BCT) provided the initiative to formally compare our standard technology, the COBE2991 (Ficoll, manual, "C") with the Spectra Optia BMP (apheresis, semiautomatic, "O"), the Sepax II NeatCell (Ficoll, automatic, "S"), the Miltenyi CliniMACS Prodigy density gradient separation system (Ficoll, automatic, "P"), and manual Ficoll ("M"). C and O handle larger product volumes than S, P, and M. STUDY DESIGN AND METHODS: Technologies were assessed for RBC depletion, target cell (mononuclear cells [MNCs] for buffy coats [BCs], CD34+ cells for BM) recovery, and cost/labor. BC pools were simultaneously purged with C, O, S, and P; five to 18 BM samples were sequentially processed with C, O, S, and M. RESULTS: Mean RBC removal with C was 97% (BCs) or 92% (BM). From both products, O removed 97%, and P, S, and M removed 99% of RBCs. MNC recovery from BC (98% C, 97% O, 65% P, 74% S) or CD34+ cell recovery from BM (92% C, 90% O, 67% S, 70% M) were best with C and O. Polymorphonuclear cells (PMNs) were depleted from BCs by P, S, and C, while O recovered 50% of PMNs. Time savings compared to C or M for all tested technologies are considerable. CONCLUSION: All methods are in principle suitable and can be selected based on sample volume, available technology, and desired product specifications beyond RBC depletion and MNC and/or CD34+ cell recovery.

Apheresis in developing countries around the World.

At the combined American Society for Apheresis (ASFA) Annual Meeting/World Apheresis Association (WAA) Congress in San Francisco, California, in April of 2014, the opening session highlighted the status of apheresis outside of the United States. The organizers invited physicians active in apheresis in countries not usually represented at such international gatherings to give them a forum to share their experiences, challenges, and expectations in their respective countries with regard to both donor and therapeutic apheresis. Apheresis technology is expensive as well as technically and medically demanding, and low and median income countries have different experiences to share with the rest of the world. Apheresis procedures also require resources taken for granted in the developed world, such as reliable electrical power, that can be unpredictable in parts of the developing world. On the other hand, it was obvious that there are significant disparities in access to apheresis within the same country (such as in Brazil), as well as between neighboring nations in Africa and South America. A common trend in the presentations from Brazil, Indonesia, Malaysia, Nigeria, and South Africa, was the need for more and better physicians and practitioners' training in the indications of the various apheresis modalities and patient oversight during the procedures. As ASFA and WAA continue to work together, and globalization allows for increased knowledge-sharing, improved access to apheresis procedures performed by qualified personnel with safety and high-quality standards will be increasingly available.

Plerixafor on-demand combined with chemotherapy and granulocyte colony-stimulating factor: significant improvement in peripheral blood stem cells mobilization and harvest with no increase in costs.

To date, no prospective study on Plerixafor 'on-demand' in combination with chemotherapy and granulocyte colony-stimulating factor (G-CSF) has been reported. We present an interim analysis of the first prospective study in which Plerixafor was administered on-demand in patients affected by multiple myeloma and lymphoma who received high dose cyclophosphamide or DHAP (dexamethasone, cytarabine, cisplatin) plus G-CSF to mobilize peripheral blood stem cells (PBSC). One hundred and two patients were evaluable for response. A cohort of 240 patients receiving the same mobilizing chemotherapy was retrospectively studied. Failure to mobilize CD34(+) cells in peripheral blood was reduced by 'on-demand' strategy compared to conventional mobilization; from 13·0 to 3·0% (P = 0·004). Failure to harvest CD34(+) cells 2 × 10(6) /kg decreased from 20·9 to 4·0% (P = 0·0001). The on-demand Plerixafor strategy also resulted in a lower rate of mobilization failure (P = 0·03) and harvest failure (P = 0·0008) when compared to a 'bias-adjusted set of controls'. Evaluation of economic costs of the two strategies showed that the overall cost of the two treatments were comparable when salvage mobilizations were taken into account. When in combination with cyclophosphamide or DHAP plus G-CSF, the 'on-demand' use of Plerixafor showed, in comparison to conventionally treated patients, a significant improvement in mobilization of PBSC with no increase in overall cost.

Model calculations to quantify clinical and economic effects of pathogen inactivation in platelet concentrates.

BACKGROUND: Future shortages in platelet supply are expected in Germany due to demographic changes. A rising cancer incidence will lead to an increasing demand for platelet concentrates (PCs) while the number of potential donors will decrease. Pathogen inactivation (PI) aims to inactivate various infectious agents including emerging pathogens to extend the shelf-life of PCs and reduce the frequency of acute transfusion reactions (ATRs). In this context, the clinical and economic impact of PI on platelet transfusion was evaluated. MATERIAL AND METHODS: Model calculations were conducted for 2 scenarios considering different production settings. Frequencies of ATRs were based on literature analyses, platelet and ATR costs on cost analyses. RESULTS: The estimated average costs for ATRs of grade 1 and 2, irrespective of origin, and grade 3 (allergic) were € 104, € 238, and € 1,200, respectively. Approximately 400 PC-related ATRs per 10(5) transfusions can be avoided, with estimated savings amounting to € 77,000. The total cost increase was calculated to approximately € 30-50 per PI-treated PC. CONCLUSION: PI potentially saves plasma, prolongs shelf-life, decreases donor deferral, and reduces ATRs. Model calculations considering clinical and safety benefits of PI show a rational cost increase. The impact of PI should be further evaluated from a societal perspective regarding future blood supply and infectious disease globalization.

Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial.

BACKGROUND: Standard treatment of newly diagnosed HFE hemochromatosis patients is phlebotomy. Erythrocytapheresis provides a new therapeutic modality that can remove up to three times more red blood cells per single procedure and could thus have a clinical and economic benefit. STUDY DESIGN AND METHODS: To compare the number of treatment procedures between erythrocytapheresis and phlebotomy needed to reach the serum ferritin (SF) target level of 50 µg/L, a two-treatment-arms, randomized trial was conducted in which 38 newly diagnosed patients homozygous for C282Y were randomly assigned in a 1:1 ratio to undergo either erythrocytapheresis or phlebotomy. A 50% decrease in the number of treatment procedures for erythrocytapheresis compared to phlebotomy was chosen as the relevant difference to detect. RESULTS: Univariate analysis showed a significantly lower mean number of treatment procedures in the erythrocytapheresis group (9 vs. 27; ratio, 0.33; 95% confidence interval [CI], 0.25-0.45; Mann-Whitney p < 0.001). After adjustments for the two important influential factors initial SF level and body weight, the reduction ratio was still significant (0.43; 95% CI, 0.35-0.52; p < 0.001). Cost analysis showed no significant difference in treatment costs between both procedures. The costs resulting from productivity loss were significantly lower for the erythrocytapheresis group. CONCLUSION: Erythrocytapheresis is highly effective treatment to reduce iron overload and from a societal perspective might potentially also be a cost-saving therapy.

Pegfilgrastim- versus filgrastim-based autologous hematopoietic stem cell mobilization in the setting of preemptive use of plerixafor: efficacy and cost analysis.

BACKGROUND: Plerixafor enhances the ability of filgrastim (FIL) to mobilize CD34+ cells but adds cost to the mobilization. We hypothesized that replacing weight-based FIL with flat-dose pegfilgrastim (PEG) in a validated cost-based mobilization algorithm for patient-adapted use of plerixafor would add convenience without increased cost. STUDY DESIGN AND METHODS: A single-center retrospective analysis compared two consecutive cohorts undergoing FIL or PEG mobilization before autologous hematopoietic stem cell transplantation for multiple myeloma or lymphoma. FIL dose was 10 µg/kg/day continuing until completion of collection and a 12-mg flat dose of PEG. Peripheral blood CD34+ cells (PB-CD34+) enumeration was performed on the fourth day after initiation of growth factor. Subjects surpassing a certain target-specific threshold of PB-CD34+ started apheresis immediately while subjects with lower PB-CD34+ received plerixafor with apheresis starting on the fifth day. RESULTS: Overall 68 of 74 in the FIL group and 52 of 57 patients in the PEG group met the mobilization target. Only one patient in each cohort required remobilization. Median PB-CD34+ on Day 4 was significantly higher in patients in the PEG group (18.1×10(6) vs. 28.7×10(6)cells/L, p=0.01). Consequently, patients in the PEG group were less likely to require administration of plerixafor (67.5% vs. 45.6%, p=0.01). Cohorts had near identical mean number of apheresis sessions and comparable CD34+ yield. The estimated cost associated with growth factor was higher in patients in the PEG group, but it was counterbalanced by lower cost associated with use of plerixafor. CONCLUSION: Single administration of 12 mg of PEG is associated with better CD34+ mobilization than FIL allowing for effective, convenient mobilization with less frequent use of plerixafor.

Preparation of blood products for transfusion: is there a best method?

There are a number of possible methods for the preparation of blood components. These vary with respect to risks and benefits to the blood system operation, to the donor and to the recipient. An understanding of these risks is necessary when deciding what component production strategies to pursue. This manuscript reviews the elements that should be considered when choosing which components to produce. The two broad schemas for component production are apheresis and the production of components from whole blood donations. The development of apheresis technologies brought significant benefits to the patient including improving the access to specialty products such as HLA-matched platelets. Benefits to blood centers include the collection of multiple transfusion doses from a single collection procedure. The challenges include the cost of the technology and a small increased risk to donors. Whole blood component preparation offers two main forms of technology: platelet rich plasma, and buffy coat, both of which are driven by platelet production. The two have different risk profiles, with overall benefits being more favorable to buffy coat production methods particularly with respect to improved process control. Issues such as donor variability affect all production methods and require further research.

[Apheresis in ABO-incompatible kidney transplant]. / L'aferesi nel trapianto di rene ABO-incompatibile.

Living donor kidney transplantation is the preferred therapeutic option for patients with end stage renal disease. Unfortunately, about 20-30% of potential living kidney donors are rejected because of incompatible immunological barriers such as ABO incompatibility. The newest desensitization protocols based on therapeutic apheresis and perioperative immunosuppressive drugs have allowed to overcome antibody barriers. The aim of these protocols is to wash out and suppress as many anti-A or anti-B antibodies as possible and to prevent rebound phenomena after transplantation. Standard plasmapheresis, double-filtration plasmapheresis, and selective immunoadsorption are among the most common apheresis modalities applied in ABO-incompatible transplantation. Selective immunoadsorption appears to be much safer and to have markedly increased efficacy compared with plasmapheresis, as it eliminates almost exclusively blood-group antibodies, thus avoiding plasma and coagulation abnormalities. According to the literature, long-term patient and graft survival rates are similar to those achieved with ABO-compatible kidney transplants. We have used selective immunoadsorption in two ABO-incompatible kidney transplants performed at our institution. No acute rejection was observed at 12 and 32 months' follow-up and both grafts are functioning well. Despite the widespread use of ABO-incompatible kidney transplant, however, the mechanisms of accommodation, the best desensitization protocol, the upper baseline and perioperative isoagglutinin titer limit, and the most accurate isoagglutinin measurement assay are still to be defined.

Cost and clinical analysis of autologous hematopoietic stem cell mobilization with G-CSF and plerixafor compared to G-CSF and cyclophosphamide.

Plerixafor plus granulocyte-colony stimulating factor (G-CSF) has been shown to mobilize more CD34(+) cells than G-CSF alone for autologous hematopoietic stem cell transplantation (HSCT). However, many centers use chemotherapy followed by G-CSF to mobilize CD34(+) cells prior to HSCT. We performed a retrospective study of patients who participated in the expanded access program (EAP) of plerixafor and G-CSF for initial mobilization of CD34(+) cells, and compared outcomes to matched historic controls mobilized with cyclophosphamide 3-5 g/m(2) and G-CSF at 2 centers that participated in the EAP Control patients were matched for age, sex, disease, disease stage, and number of prior therapies. Mobilization costs were defined to be the costs of medical procedures, resource utilization, and medications. Median national CMS reimbursement rates were used to establish the costs of procedures, hospitalization, provider visits, apheresis, CD34(+) cell processing and cryopreservation. Average sale price was used for G-CSF, plerixafor, cyclophosphamide, MESNA, antiemetics, and antimicrobials. A total of 33 patients from the EAP and 33 matched controls were studied. Two patients in the control group were hospitalized for neutropenic fever during the mobilization period. Apheresis started on the scheduled day in 33 (100%) study patients and in 29 (88%) control patients (P = 0.04). Sixteen (48%) control patients required weekend apheresis. There was no difference in number of CD34(+) cells collected between the groups, and all patients proceeded to HSCT with no difference in engraftment outcomes. Median total cost of mobilization was not different between the plerixafor/G-CSF and control groups ($14,224 versus $18,824; P = .45). In conclusion, plerixafor/G-CSF and cyclophosphamide/G-CSF for upfront mobilization of CD34(-) cells resulted in similar numbers of cells collected, costs of mobilization, and clinical outcomes. Additionally, plerixafor/G-CSF mobilization resulted in more predictable days of collection, no weekend apheresis procedures, and no unscheduled hospital admissions.

The implementation of rapid cooling and overnight hold of whole blood at ambient temperature before processing into components in Israel.

BACKGROUND: The quality of blood components prepared from whole blood (WB) units rapidly cooled to 20 to 24°C and stored for prolonged periods using butane-1,4-diol "cooling plates," and the factors that determine the functional activity of these cooling systems under various temperature conditions were investigated. STUDY DESIGN AND METHODS: Validation of the cooling systems functions, performed in different environmental temperature-time schemes using WB-mock units, were recorded and analyzed in 106 temperature curves, simulating environmental conditions of blood storage at the blood drives and transport to the blood services component laboratory. The quality of red blood cells, fresh-frozen plasma, platelet concentrates, and cryoprecipitate units was studied on components routinely prepared in 2007 to 2009 from WB units collected in citrate-phosphate-dextrose-adenine or citrate-phosphate-dextrose (CPD), rapidly cooled, and stored in ambient temperature for up to 22 hours postdonation using the cooling systems. RESULTS: Quality variables of blood components prepared from WB units rapidly cooled and held overnight for up to 22 hours postcollection, using both cooling systems, met the allowed ranges of American, European, and Israeli standards. Temperature validation of the cooling systems resulted in national standard operating procedures for the proper use in different ambient temperature ranges. CONCLUSION: The rapid cooling of WB and prolonged storage under different environmental conditions using cooling plate systems enabled standardization of blood storage at and transportation from all collection sites. It provided an efficient, reproducible, and cost-effective way to ensure good quality blood components, while utilizing more efficient logistic and administrative means.

Low-cost protocol for the production of autologous serum eye drops by blood collection and processing centres for the treatment of ocular surface diseases.

OBJECTIVES: To create a low-cost protocol for the production of autologous serum eye drops (ASEs) by blood collection and processing centres using standard equipment and staff already available. The protocol must observe local and federal regulatory authorities' requirements for good manufacturing practice. AIM: The final aim is to improve accessibility to ASEs for patients who need them and to implement similar production parameters at all institutions producing ASEs. BACKGROUND: Despite evidence of the beneficial effects of ASEs in the treatment of severe ocular surface diseases, ASEs are not approved by most federal regulatory bodies in the United States or Europe. In some countries, such as the United States, access to ASEs is extremely limited and cost-prohibitive. Blood processing centres are in optimal position to help in increasing accessibility and lowering the cost of these products. MATERIALS/METHODS: Standard blood processing equipment, staff and materials were chosen for the protocol. The protocol was designed to minimise the risk of contamination as much as possible. RESULTS: A low-cost, open system protocol for production of ASEs was generated that can be implemented by most blood collection and processing centres in the United States and Europe. CONCLUSION: Efforts should be made to propagate a similar protocol for the production of ASEs in blood centres capable of collecting and processing blood products, making this service affordable and uniformly accessible to patients.

Comparison of plasmapheresis with medical apheresis in terms of efficacy and cost in the acute treatment of hypertriglyceridemia in children with lipoprotein lipase deficiency.

OBJECTIVES: We aimed to compare plasmapheresis and medical apheresis as lipid-lowering therapies in children with familial lipoprotein lipase (LPL) deficiency. METHODS: The data of 13 patients who were followed up after a diagnosis of LPL deficiency were retrospectively analyzed. Plasma triglyceride, cholesterol, amylase, and lipase values and complications were recorded before and after each patient underwent plasmapheresis or medical apheresis. RESULTS: The mean follow-up period of the patients was 99.64 ± 52.92 months in the medical apheresis group and 118 ± 16.97 months in the plasmapheresis group. While the mean triglyceride level before plasmapheresis was 1,875.38 ± 547.46 mg/dL, it was 617 ± 228.28 mg/dL after plasmapheresis. While the mean triglyceride level before medical apheresis was 1,756.86 ± 749.27 mg/dL, it was found to be 623.03 ± 51.36 mg/dL after medical apheresis. Triglyceride levels were decreased by 59.62% with medical apheresis and 65.57% with plasmapheresis. The cost of treatment for medical apheresis was found to be lower compared to plasmapheresis 296.93 ± 29.94 Turkish lira (USD 43.34 ± 4.01) vs. 3,845.42 ± 156.17 Turkish lira (USD 561.37 ± 20.93; p<0.001). CONCLUSIONS: Although there is no standardized strategy for the acute treatment of hypertriglyceridemia due to LPL deficiency, medical apheresis is a safe and effective treatment with a low risk of side effects. Unlike plasmapheresis, medical apheresis can be performed in any center, which is another important advantage of the procedure.