Comparison of automated erythrocytapheresis versus manual exchange transfusion to treat cerebral macrovasculopathy in sickle cell anemia.

BACKGROUND: Chronic exchange transfusion is effective for primary and secondary prevention of stroke in children with sickle cell anemia (SCA). Erythrocytapheresis is recognized to be the most efficient approach; however, it is not widely implemented and is not suitable for all patients. The aim of our study was to compare automated exchange transfusion (AET) with our manual method of exchange transfusion and, in particular, to evaluate the efficacy, safety, and cost of our manual method. STUDY DESIGN AND METHODS: Thirty-nine SCA children with stroke and/or abnormal findings on transcranial Doppler were included in the study. We retrospectively analyzed 1353 exchange sessions, including 333 sessions of AET and 1020 sessions of manual exchange transfusion (MET). RESULTS: Both methods were well tolerated. The median decrease in hemoglobin (Hb)S per session was 21.5% with AET and 18.8% with our manual method (p < 0.0001) with no major increase in red blood cell consumption. Iron overload was well controlled, even with the manual method, with a median (interquartile range) ferritin level of 312 (152-994) µg/L after 24 months of transfusions. The main differences in annual cost relate to equipment costs, which were 74 times higher with the automated method. CONCLUSION: Our study shows that continuous MET has comparable efficacy to the automated method in terms of stroke prevention, decrease in HbS, and iron overload prevention. It is feasible in all hospital settings and is often combined with AET successively over time.

Comparative evaluation of the depletion-red cell exchange program with the Spectra Optia and the isovolemic hemodilution-red cell exchange method with the COBE Spectra in sickle cell disease patients.

BACKGROUND: This study aims to compare in patients with sickle cell disease (SCD), the technical performance and packed red blood cell unit consumption between the automated depletion/Red Blood Cell exchange (RBCx) program (Spectra Optia Apheresis System) with the isovolemic hemodilution (IHD)/RBCx procedure (COBE Spectra Apheresis System) in a routine clinical setting. METHODS: We retrospectively reviewed the data of 23 patients treated between October 2010 and August 2013 who underwent repeated RBCx on both apheresis systems for preventive indications. Each patient was their own control and had undergone two procedures on each system, totaling 46 sessions per group. On Spectra Optia, we performed the automated depletion/RBCx program. For COBE Spectra, we used a modified IHD/RBCx protocol. All patients had an initial 250 mL depletion offset by a 5% albumin prior to the exchange procedure, for the respective device, with leucodepleted Rh/Kell compatible and cross-matched RBC packs. RESULTS: All procedures were well tolerated except three mild febrile nonhemolytic reactions. Postprocedure hemoglobin S (HbS), fraction of cells remaining (FCR), procedure duration and processed blood and anticoagulant volumes were comparable in the two groups. However, the RBCx volume was significantly higher for the Spectra Optia group (+71 mL, P = 0.01), with no significant difference in the number of RBC units used. CONCLUSIONS: Technical performance and packed RBC unit consumption were not compromised when switching from the COBE Spectra IHD/RBCx protocol to the depletion/RBCx protocol on the Spectra Optia. Tolerability was equal for both protocols. J. Clin. Apheresis 31:429-433, 2016. © 2015 Wiley Periodicals, Inc.

Quality of red blood cells washed using a second wash sequence on an automated cell processor.

BACKGROUND: Washed red blood cells (RBCs) are indicated for immunoglobulin (Ig)A-deficient recipients when RBCs from IgA-deficient donors are not available. Canadian Blood Services recently began using the automated ACP 215 cell processor (Haemonetics Corporation) for RBC washing, and its suitability to produce IgA-deficient RBCs was investigated. STUDY DESIGN AND METHODS: RBCs produced from whole blood donations by the buffy coat (BC) and whole blood filtration (WBF) methods were washed using the ACP 215 or the COBE 2991 cell processors and IgA and total protein levels were assessed. A double-wash procedure using the ACP 215 was developed, tested, and validated by assessing hemolysis, hematocrit, recovery, and other in vitro quality variables in RBCs stored after washing, with and without irradiation. RESULTS: A single wash using the ACP 215 did not meet Canadian Standards Association recommendations for washing with more than 2 L of solution and could not consistently reduce IgA to levels suitable for IgA-deficient recipients (24/26 BC RBCs and 0/9 WBF RBCs had IgA levels < 0.05 mg/dL). Using a second wash sequence, all BC and WBF units were washed with more than 2 L and had levels of IgA of less than 0.05 mg/dL. During 7 days' postwash storage, with and without irradiation, double-washed RBCs met quality control criteria, except for the failure of one RBC unit for inadequate (69%) postwash recovery. CONCLUSION: Using the ACP 215, a double-wash procedure for the production of components for IgA-deficient recipients from either BC or WBF RBCs was developed and validated.

Preparation of red blood cell concentrates and plasma units from whole blood held overnight using a hollow-fibre separation system.

BACKGROUND: The ErySep system represents an alternative to centrifuge-based whole blood (WB) separation, using gravity and filtration through hollow-fibres (0·2 µm pore size) to produce red blood cell (RBC) and plasma components. The aim of this study was to characterise the quality of ErySep RBC and plasma units compared with standard products from WB held overnight. METHODS/MATERIALS: Two ABO-compatible WB units (n = 24) were pooled and split to produce matched products. One of the WB units was separated into components using the ErySep system (ErySep; n = 12), whereas the other units were separated by centrifugation (control; n = 12). RBC units were stored at 2-6 °C and assessed for in vitro quality over 42 days of storage. Plasma was frozen at -30 °C and tested upon thawing. RESULTS: Processing WB with the ErySep system took longer than controls. The ErySep RBC units were of an appropriate volume (307 ± 17 mL) and contained sufficient Hb (50 ± 2 g unit(-1) ). ErySep RBC components contained more microparticles relative to controls at expiry. The plasma volume, total protein, coagulation factor activity (fibrinogen, FV, FVIII) and number of microparticles was lower in the ErySep units compared with controls. CONCLUSION: Following overnight hold of WB, the ErySep system was capable of producing RBC components that met specifications. However, the ErySep plasma components did not meet quality specifications.

Effective collection of peripheral blood stem cells in children weighing 20 kilogram or less in a single large-volume apheresis procedure.

INTRODUCTION: Peripheral blood stem cell (PBSC) transplantation has become a routine procedure in pediatric oncology. A special group of PBSC donors are children weighing 20 kg or less. Limited vascular access and low blood volume puts them at a higher risk. Central line placement and a priming apheresis machine are recommended to avoid these complications. PATIENTS AND METHODS: PBSC collections performed from July 2006 to May 2013 in children weighing less than 20 kg were included. All donors had a central venous catheter (CVC). An apheresis machine was primed with packet red blood cells. RESULTS: Twenty-seven PBSC collections were performed in 22 children weighing 20 kg or less, 14 for allogeneic and 8 for autologous transplantation, in order to collect at least 2 × 10(6) CD34+ cells/kg. In the allogeneic group, median age and weight were 3 years (0.8-7) and 15.5 kg (8-20). In the autologous group, median age and weight were 3 years (2-7) and 15.35 kg (12.5-19.5). A single large-volume apheresis was sufficient to obtain the CD34+ cells needed in 78.5% and 75% of the allogeneic and autologous groups, respectively, with a median 11.84 × 10(6) and 5.79 × 10(6) CD34+ cells collected per kilogram of weight of the recipient. No serious complications related to the apheresis procedure or CVC placement occurred. CONCLUSION: PBSC collection in a single large-volume apheresis for allogeneic and autologous transplants in children weighing 20 kg or less is a safe and effective procedure when based on standardized protocols.

[TERMINOLOGY OF THE PROCEDURES OF DRAWING BLOOD AND RECEIVING IT COMPONENTS].

The paper discusses the appropriate use of terminology denoting different types and different ways of blood sampling those of its components with the semantic, phonetic and technological point of view.

Erythrocyte-exchange with the OPTIA™ cell separator in patients with sickle-cell disease.

Erythrocyte-exchange (EEX) has proven to be a very useful tool in sickle-cell disease (SCD) patients either during acute painful crisis unresponsive to hydration and/or analgesia or as a prophylactic treatment in high risk patients in those who do not tolerate hydroxyurea (HU), with the aim of lowering HbS levels. EEX may be performed either by using continuous- or discontinuous flow devices, the former being of choice in children or in low-weight patients. Thus, a low extracorporeal blood volume (EBV) could allow for a better and safer procedure management. In this study we compared EEX procedure performed with the recently released OPTIA device with EEX procedures performed using the COBE Spectra device (EBV 185 vs 270 mL, respectively). Twenty-one EEX (4 as emergency treatment) were performed in 12 patients with the Spectra device and 25 (9 as emergency treatment) in 15 patients with the OPTIA device. All the procedures were well tolerated and uneventful. We did not observe significant differences between the two devices as to pre- and post-EEX parameters, namely in target hematocrit and in HbS reduction. Noteworthy, due to the lowest EBV allowed by the OPTIA device, an EEX procedure performed in a 13 Kg- child did not require a preliminary priming of the circuit. In conclusion, the OPTIA device proved to be as effective as the Spectra device in treating SCD patients either during sickling crisis or as prophylactic therapy. The OPTIA device can be safely used in the pediatric setting since it allows a lower EBV.

[Promising technologies of packed red blood cells production and storage].

The current article is dedicated to promising technologies of packed red blood cells production and storage. The following new technical approaches are presented: (1) erythrocytes storage in strict anaerobic argon-hydrogen environment, (2) lyophilization of erythrocyte suspension by its atomization in nitrogen gas, (3) lyophilization of erythrocytes by directional freezing under the influence of radio frequency radiation, (4) automated pharming of antigen free packed red blood cells from progenitor cell directly at the battlefield.

Automated processing of whole blood units: operational value and in vitro quality of final blood components.

BACKGROUND: The Community Transfusion Centre in Madrid currently processes whole blood using a conventional procedure (Compomat, Fresenius) followed by automated processing of buffy coats with the OrbiSac system (CaridianBCT). The Atreus 3C system (CaridianBCT) automates the production of red blood cells, plasma and an interim platelet unit from a whole blood unit. Interim platelet unit are pooled to produce a transfusable platelet unit. In this study the Atreus 3C system was evaluated and compared to the routine method with regards to product quality and operational value. MATERIALS AND METHODS: Over a 5-week period 810 whole blood units were processed using the Atreus 3C system. The attributes of the automated process were compared to those of the routine method by assessing productivity, space, equipment and staffing requirements. The data obtained were evaluated in order to estimate the impact of implementing the Atreus 3C system in the routine setting of the blood centre. Yield and in vitro quality of the final blood components processed with the two systems were evaluated and compared. RESULTS: The Atreus 3C system enabled higher throughput while requiring less space and employee time by decreasing the amount of equipment and processing time per unit of whole blood processed. Whole blood units processed on the Atreus 3C system gave a higher platelet yield, a similar amount of red blood cells and a smaller volume of plasma. DISCUSSION: These results support the conclusion that the Atreus 3C system produces blood components meeting quality requirements while providing a high operational efficiency. Implementation of the Atreus 3C system could result in a large organisational improvement.

[Effectiveness of therapeutic erythrocytapheresis to achieve iron depletion in hereditary type 1 hemochromatosis: report of 30 cases]. / Intérêt des érythraphérèses à la phase initiale du traitement des hémochromatoses génétiques de type 1: expérience à propos de 30 cas.

PURPOSE OF THE STUDY: Weekly phlebotomy schedule is commonly recommended to achieve iron depletion in hereditary hemochromatosis (HH). However, in patients with severe iron overload, more than 2 years may be required, leading to fatigue and lack of compliance. For more than 10 years, we have used erythrocytapheresis (EA) as an alternative treatment. PATIENTS AND METHODS: To assess the number of EA to achieve iron depletion and the duration of the iron depletion therapy as well of the tolerance, we retrospectively analysed the data of newly diagnosed hemochromatosis patients, homozygote for the C282Y mutation, followed in our department between 2001 and 2007. EA were performed using a discontinuous or a continuous flow cell separators. The protocol consisted in a bimonthly EA until normalisation of the serum ferritin, with the aim of reducing the patient's hematocrit between 32-35% at the end of each session. Then we performed monthly EA until complete desaturation, defined as serum ferritin concentration below 50 µg/L and transferrin saturation below 40%. RESULTS: Thirty patients were included (23 male, mean age 52 years, range 25-78) and 625 procedures analyzed. The mean volume of removed erythrocytes in each procedure was 416.4 mL (range 150-948), which equals to 374 mg of removed iron. Iron depletion (ferritin < 50 µg/L) was achieved after 11 months with 20 sessions (range 14-78). No serious adverse reactions or citrate toxicity were observed during and after the apheresis procedures. No specific fatigue was reported during the iron depletion therapy. Patient compliance was 100%. Clinical improvement was noted in 12 out of 18 of symptomatic patients. CONCLUSION: We conclude that HH patients treated with bimonthly EA achieved iron depletion in less than 1 year under good condition of tolerance. These data support the use of EA in patients with a severe iron overload, since it may reduce the number of the procedures as well as the duration of the iron depletion therapy.

Preliminary studies for the development of a second generation granulocytapheresis (G-CAP) column. Part II: in vitro and ex vivo studies.

Our previous studies concluded Egyptian cotton was the most appropriate material for making a second generation granulocytapheresis (G-CAP) column as structural dimensions of the cotton fibers are able to attract granulocytes. Unfortunately, it is considered to be blood incompatible as its fibers are of non-synthetic origins. In this study we examined the alteration of the removal rates of blood cells with different surface modifications of Egyptian cotton to enhance its blood compatibility. The surface-modified cotton fibers were compared after three kinds of combination treatments. There were no differences in the removal rates of white blood cells (WBCs) and particularly neutrophils with the use of three kinds of biolized cottons. Next, an ex vivo animal study with a healthy dog was performed with the prototype of the G-CAP column. The dog's blood pressure (BP) decreased to approximately 80% of the initial values of BP at 20 min after the start of the extracorporeal circulation. The decrease in BP gradually reverted to normal. WBCs and particularly neutrophils decreased significantly at 15 min after the start of the extracorporeal circulation and remained low during the extracorporeal circulation. The ability of this column to remove WBCs was maintained during extracorporeal circulation. Especially, neutrophils at the inlet of the column were thoroughly removed for 1 h. Based upon these results, a second generation G-CAP column could be fabricated with Egyptian cotton and applied for clinical use on the condition that the biocompatibility of the Egyptian cotton needs to be improved by the appropriate biolization method.

Mobilized allogeneic peripheral stem/progenitor cell apheresis with Spectra Optia v.5·0, a novel, automatic interface-controlled apheresis system: results from the first feasibility trial.

BACKGROUND AND OBJECTIVES: G-CSF mobilized peripheral blood stem/progenitor cells are frequently used for allogeneic transplantation. Available manual apheresis systems generate stem cell products of consistently high quality. Short-comings include need for continuous interface monitoring/adjustment, interface instability in donors with inconsistent blood flow, high collection variability, high platelet loss, and failure to electronically document apheresis parameters. MATERIAL AND METHODS: A fundamentally different, novel apheresis system, Spectra Optia v.5·0, featuring optical sensors, which provide real-time automatic interface and product collect line control, and newly developed tubing sets, was designed to address these short-comings. In a prospective validation study, 30 healthy volunteer stem cell donors were subjected to apheresis with Spectra Optia to test feasibility and effectiveness. Results were compared to 608 historic first-day allogeneic aphereses with COBE Spectra MNC. RESULTS: Usability and function of automatic interface control of Spectra Optia were good. Most collection parameters, including collection efficiency and product size, were similar. Cells were viable and provided timely engraftment. Platelet loss with Spectra Optia was 25% less than with COBE Spectra MNC. Products contained fewer erythrocytes, but more granulocytes. CONCLUSION: The automatic apheresis system Spectra Optia is functional and user-friendly. Thus Spectra Optia aphereses are associated with similar, and equally variable, collection efficiencies as COBE Spectra MNC.

Evaluation of a new cell separator for collection of peripheral blood CD34+ progenitor cells in pediatric patients.

BACKGROUND: This study was conducted to evaluate the performance of the COM.TEC cell separator (Fresenius HemoCare GmbH) for collecting CD34+ cells in pediatric patients who were intended to have autologous peripheral blood progenitor cell transplantation, with respect to collection variables, prediction power of CD34+ cell yield, and influence on donors. STUDY DESIGN AND METHODS: A total of 26 pediatric solid tumor patients who received mobilization chemotherapy and granulocyte-colony-stimulating factor underwent CD34+ cell collection (n = 96) using the COM.TEC auto mononuclear cell (MNC) program. Patients were divided into a neuroblastoma (NBL) group and a brain tumor group according to the intensity of prior chemotherapy regimens. The collection variables, cellular variables of leukapheresis products, and the peripheral blood cell counts of patients were compared with those acquired using the COBE Spectra (GambroBCT). The CD34+ cell collection efficiency (CE) and the percentage ratios of actual to predicted CD34+ cell yield indicating prediction power were analyzed. RESULTS: Using the COM.TEC auto MNC program, the processing rate was higher and the product volume was smaller (p < 0.05) than those of the COBE Spectra. Platelet (PLT) reduction in peripheral blood and PLT contamination of the products were significantly lower (p < 0.01). The median CE was less than 60% in both patient groups (50.0 and 48.4%, respectively). The actual collected CD34+ cell yields were medians of 66.9 and 76.1% of the predicted values in NBL group and brain tumor group, respectively. CONCLUSION: PBPC collections by the COM.TEC cell separator had advantages of high processing rate, low product volume, and low contamination by PLTs of product. Low PLT loss was observed in pediatric patients who need to collect autologous PBPCs. However, applying CD34+ cell yield prediction was not practical for prospective scheduling of the next collection. More specified data need to be accumulated for more accurate prediction of CD34+ cell yield in pediatric patients.

Double red cell concentrates -in vitro quality after delayed refrigeration.

Automated collection of red cell concentrates (RCC) presents a number of potential advantages to donors, blood services and recipients, and allows the collection of finished components from sites that are remote from a blood centre. However, data are lacking on how long the collected RCC may be stored at ambient temperature prior to their final storage at 4 °C. In this study, the Haemonetics Cymbal device was used to collect RCC using citrate, phosphate and dextrose (CPD-50) anticoagulant. A total of 10 procedures each yielded two leucodepleted RCC in saline, adenine, glucose and mannitol (SAGM) additive solution. One of each pair of RCC was kept warm in an insulated transport bag for 8 h and the other for 6 h. In vitro assessments of the quality of the RCC were made during subsequent 42-day storage of the RCC at 2-6 °C, and compared with reference data. All collected RCC were within UK and European limits for volume, haematocrit and haemoglobin content. Haemolysis was within specification at Day 42 and was no different in RCC held warm for 6 or 8 hours, but tended to be higher than reference data from whole blood derived RCC. ATP, 2,3 DPG and supernatant potassium levels were all similar in RCC held warm for 6 or 8 hours and reference data. We conclude that the Cymbal device may be used to collect two RCC in SAGM, and the in vitro assessment indicates that RCC may be stored without refrigeration for up to 8 h following collection, prior to final storage at 4 °C.

Reducing blood transfusion requirements in preterm infants by a new device: a pilot study.

OBJECTIVE: To test a new device designed to salvage red blood cells (RBCs) from blood samples drawn from preterm infants, with the intent of decreasing blood loss and lowering the requirements for RBC transfusions. DESIGN: A case-controlled pilot study was conducted in two Israeli neonatal intensive care units in large municipal hospitals. Twenty low-birthweight preterm infants were randomly and equally divided into the ErythroSave group or a control group. All blood tests in the study group (except for complete blood count and coagulation parameters) were obtained during the first week of life by the new device in the study group and by ordinary syringes in the control group. The main outcome measure was the total number of units of blood needed. RESULTS: The average volume of blood obtained for laboratory analyses from each infant was 27 mL in the ErythroSave group and 24 mL in controls (not significant). The average volume of transfused packed cells was 6.4 mL for the ErythroSave group and 21.3 mL for the controls (p = 0.008). CONCLUSION: The use of ErythroSave for sampling blood significantly reduced blood transfusion requirements in premature infants compared to sampling by conventional syringes.

Granulocytapheresis in the treatment of patients with active ulcerative colitis.

In recent years, considering the role of inflammatory processes and the involvement of the immune system in ulcerative colitis, granulocytapheresis, a technique for removing circulating leukocytes and preventing their migration into the intestinal mucosa, has been proposed for the treatment of acute ulcerative colitis. Initially introduced for the treatment of patients who did not respond to conventional therapy only, this new therapy may become a useful and safe method to induce clinical remission in patients with acute disease. This article will review the clinical applications and issues concerning the use of granulocytapheresis in ulcerative colitis.

Cytapheresis in inflammatory bowel diseases: current evidence and perspectives.

Ulcerative colitis and Crohn's disease are inflammatory bowel diseases with a chronic relapsing course. Management of both conditions is far from being fully satisfactory. For this reason in the last decade a large number of biological therapies, targeting cytokines involved in intestinal inflammation, has been developed with various results in terms of efficacy, safety and costs. Activated granulocytes and monocytes represent the major sources of pro-inflammatory cytokines in the intestinal mucosa, playing a pivotal role in inducing and maintaining intestinal inflammation. Leukocytapheresis using an adsorptive carrier-based system (Adacolumn) or a removal filter column (Cellsorba) has been proposed as a feasible, safe and effective therapy for ulcerative colitis and Crohn's disease. The objective of this paper is to provide an overview on the current knowledge about mechanisms of action, available clinical data and the possible future perspectives for the use of Adacolumn and Cellsorba in the management of inflammatory bowel diseases.

Cryopreserving and deglycerolizing sickle cell trait red blood cell components using an automated cell-processing system.

RBC components with rare phenotypes are sometimes required for patients with sickle cell disease, and these rare components can often be found among donors with sickle cell trait. Cryopreserving RBC components from sickle cell trait donors requires a modified deglycerolization method to preserve the integrity of the RBCs. This study evaluated the feasibility of using an automated cell-processing system to cryopreserve and deglycerolize sickle cell trait donor RBC components. CP2D/AS-3 RBC components were collected from three donors with sickle cell trait. Each component was processed with an automated cell-processing system (ACP 215, Haemonetics Corp., Braintree, MA) and cryopreserved within 6 days of collection. The components were stored at -65 degrees C or less for at least 2 days and were deglycerolized using the automated cell-processing system's standard procedure. Before cryopreservation and after deglycerolization, several variables were measured. Deglycerolization resulted in recovery of 43.0, 76.5, and 67.5 percent of RBCs from the three sickle-cell-trait donor components compared with 80 percent or greater for all six control components. A small, dark red, jelly-like mass was noted in the bowl of the disposable set after deglycerolization of each of the three RBC sickle cell trait components. The osmolalities of all three sickle cell trait components were less than 400 mOsm/kg, but only one of the three was acceptable for a 14-day outdate. Freezing and deglycerolization of sickle cell trait donor RBC components with the automated cell-processing system resulted in recovery of some RBCs, but a decrease in RBC recovery was problematic. Modifications of the procedure are needed for processing sickle cell trait donor RBC components.

[Cytoapheresis for IBD].

Ulcerative colitis (UC) is associated with chronic relapsing inflammation of the colon. Cytoapheresis is a therapeutic strategy of extracorporeal immunomodulation that has been used in several immunological disorders. In Japan, several open trials of cytoapheresis for UC patients accumulated encouraging results in bringing steroid-resistant patients into remission. In this paper, three types of cytoapheresis [leukocytapheresis (LCAP), granulocytapheresis (GCAP), and centrifugal leukocyte apheresis] are reviewed.