Removal of EpCAM-positive tumor cells from blood collected during major oncological surgery using the Catuvab device- a pilot study.

BACKGROUND: Intraoperative blood salvage (IBS) is regarded as an alternative to allogeneic blood transfusion excluding the risks associated with allogeneic blood. Currently, IBS is generally avoided in tumor surgeries due to concern for potential metastasis caused by residual tumor cells in the erythrocyte concentrate. METHODS: The feasibility, efficacy and safety aspects of the new developed Catuvab procedure using the bispecific trifunctional antibody Catumaxomab was investigated in an ex-vivo pilot study in order to remove residual EpCAM positive tumor cells from the autologous erythrocyte concentrates (EC) from various cancer patients, generated by a IBS device. RESULTS: Tumor cells in intraoperative blood were detected in 10 of 16 patient samples in the range of 69-2.6 × 105 but no residual malignant cells in the final erythrocyte concentrates after Catuvab procedure. IL-6 and IL-8 as pro-inflammatory cytokines released during surgery, were lowered in mean 28-fold and 52-fold during the Catuvab procedure, respectively, whereas Catumaxomab antibody was detected in 8 of 16 of the final EC products at a considerable decreased and uncritical residual amount (37 ng in mean). CONCLUSION: The preliminary study results indicate efficacy and feasibility of the new medical device Catuvab allowing potentially the reinfusion of autologous erythrocyte concentrates (EC) produced by IBS device during oncological high blood loss surgery. An open-label, multicenter clinical study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the Catuvab device is initiated to validate these encouraging results.

Intraoperative cell salvage with autologous transfusion in elective right or repeat hepatectomy: a propensity-score-matched case-control analysis.

BACKGROUND: Liver resection may be associated with substantial blood loss, and cell saver use has been recommended for patients at high risk. We performed a study to compare the allogenic erythrocyte transfusion rate after liver resection between patients who had intraoperative cell salvage with a cell saver device versus patients who did not. Our hypothesis was that cell salvage with autologous transfusion would reduce the allogenic blood transfusion rate. METHODS: Cell salvage was used selectively in patients at high risk for intraoperative blood loss based on preoperatively known predictors: right and repeat hepatectomy. Patients who underwent elective right or repeat hepatectomy between Nov. 9, 2007, and Jan. 27, 2016 were considered for the study. Data were retrieved from a liver resection database and were analyzed retrospectively. Patients with cell saver use (since January 2013) constituted the experimental group, and those without cell salvage (2007-2012), the control group. To reduce selection bias, we matched propensity scores. The primary outcome was the allogenic blood transfusion rate within 90 days postoperatively. Secondary outcomes were the number of transfused erythrocyte units, and rates of overall and infectious complications. RESULTS: Ninety-six patients were included in the study, 41 in the cell saver group and 55 in the control group. Of the 96, 64 (67%) could be matched, 32 in either group. The 2 groups were balanced for demographic and clinical variables. The allogenic blood transfusion rate was 28% (95% confidence interval [CI] 12.5%-43.7%) in the cell saver group versus 72% (95% CI 56.3%-87.5%) in the control group (p < 0.001). The overall and infectious complication rates were not significantly different between the 2 groups. CONCLUSION: Intraoperative cell salvage with autologous transfusion in elective right or repeat hepatectomy reduced the allogenic blood transfusion rate.

CONTEXTE: La résection hépatique peut s'accompagner de pertes sanguines importantes et l'utilisation d'un système de récupération de sang autologue est recommandée chez les patients à risque élevé. Nous avons procédé à une étude pour comparer le taux de transfusion de sang allogénique après la résection hépatique selon que les patients avaient ou non été soumis à une intervention de récupération de sang autologue. Notre hypothèse est que la récupération de sang autologue peropératoire pourrait réduire le taux de transfusion de sang allogénique. MÉTHODES: La récupération de sang autologue a été utilisée sélectivement chez des patients exposés à un risque élevé à l'égard de pertes sanguines peropératoires, en fonction de facteurs prédictifs préopératoires connus : hépatectomie droite et reprise de l'hépatectomie. Les patients ayant subi une intervention chirurgicale non urgente pour hépatectomie droite ou reprise d'hépatectomie entre le 9 novembre 2007 et le 27 janvier 2016 ont été considérés comme admissibles à l'étude. Les données ont été récupérées à partir d'une base de données sur la résection hépatique et analysées de manière rétrospective. Les patients soumis à la récupération de sang autologue (à partir de janvier 2013) ont constitué le groupe expérimental, et les autres (2007-2012) ont constitué le groupe témoin. Pour réduire le risque de biais de sélection, nous avons apparié les scores de propension. Le paramètre principal était le taux de transfusion de sang allogénique dans les 90 jours suivant l'opération. Les paramètres secondaires étaient le nombre d'unités transfusées, le taux de complications infectieuses et le taux global de complications. RÉSULTATS: Quatre-vingt-seize patients ont pris part à l'étude, 41 dans le groupe soumis à la récupération de sang autologue et 55 dans le groupe témoin. Parmi les 96 patients de l'étude, 64 (67 %) ont pu être assortis, 32 dans chaque groupe. Les 2 groupes étaient équilibrés aux plans des variables démographiques et cliniques. Le taux d'allotransfusions a été de 28 % (intervalle de confiance [IC] de 95 % 12,5 %-43,7 %) dans le groupe soumis à la récupération de sang autologue, contre 72 % (IC de 95 % 56,3 %-87,5 %) dans le groupe témoin (p < 0,001). Le taux de complications infectieuses et le taux global de complications n'ont pas été significativement différents entre les 2 groupes. CONCLUSION: La récupération de sang autologue peropératoire dans les cas d'hépatectomie droite ou d'hépatectomie répétée a réduit le taux de transfusion de sang allogénique.

Development of a portable blood salvage and autotransfusion technology to enhance survivability of personnel requiring major medical interventions in austere or military environments.

INTRODUCTION: Uncontrolled haemorrhage is the leading cause of death on the battlefield, and two-thirds of these deaths result from non-compressible haemorrhage. Blood salvage and autotransfusion represent an alternative to conventional blood transfusion techniques for austere environments, potentially providing blood to the casualty at point of injury. The aim of this paper is to describe the design, development and initial proof-of-concept testing of a portable blood salvage and autotransfusion technology to enhance survivability of personnel requiring major medical interventions in austere or military environments. METHOD: A manually operable, dual-headed pump was developed that removes blood from site of injury to a collection reservoir (upper pump) and back to casualty (lower pump). Theoretical flow rate calculations determined pump configuration and a three-dimensionally printed peristaltic pump was manufactured. Flow rates were tested with fresh bovine blood under laboratory conditions representative of the predicted clinical environment. RESULTS: Mathematical modelling suggested flow rates of 3.6 L/min and 0.57 L/min for upper and lower pumps. Using fresh bovine blood, flow rates produced were 2.67 L/min and 0.43 L/min. To mimic expected battlefield conditions, upper suction pump flow rate was calculated using a blood/air mixture. CONCLUSION: The authors believe that this technology can potentially enhance survivability for casualties in austere and deployed military settings through autotransfusion and cell concentration. It reduces negative effects of blood donation on the conventional donor pool, and potentially negates the logistical constraints associated with allogenic transfusions.

The impact of bowl size, program setup, and blood hematocrit on the performance of a discontinuous autotransfusion system.

BACKGROUND: Cell salvage is an essential element in the concept of blood management. Modern devices provide different bowl sizes and sensor-directed programs to optimally adjust to varying clinical situations. STUDY DESIGN AND METHODS: In an experimental performance study, the discontinuous autotransfusion device XTRA (LivaNova/Sorin) was evaluated using fresh donor blood anticoagulated with heparin 5 U/mL and adjusted to a hematocrit of 10% or 25%, representing orthopedic or cardiac surgery. Test blood was processed with the autotransfusion device XTRA in four different bowls (55 mL, 125 mL, 175 mL, and 225 mL) and in three different program modes (a standard program, an optimized program, and an emergency program). RESULTS: Processing speed increased with bowl size and with the emergency program (range, 6.4-29.8 mL red blood cells [RBCs]/min). The RBC recovery rate exceeded 90% for all bowls and programs except the 55-mL bowl with the emergency program. Plasma elimination exceeded 95% for all bowls and programs except the 225-mL bowl with the emergency and standard programs. Maximal RBC recovery (range, 94.7%-97.6%) and plasma elimination (range, 98.7%-99.5%) were obtained with the medium-sized bowls (125 mL and 175 mL) and the optimized program. Elimination rates for potassium or plasma free hemoglobin were consistently lower than for protein or albumin and were highest for heparin. CONCLUSIONS: Increased hematocrit and RBC recovery rates are obtained with the optimized program Popt with the discontinuous autotransfusion device. The emergency program Pem speeds up the process but leads to RBC loss and reduced plasma elimination rates; therefore, it should be restricted to emergency situations. All four different sized bowls have high performance. Plasma elimination is represented best by protein or albumin elimination rates.

Autologous blood salvage in the era of patient blood management.

Almost 150 years after the first autologous blood transfusion was reported, intraoperative blood salvage has become an important method of blood conservation. The primary goal of autologous transfusion is to reduce or avoid allogeneic red blood cell transfusion and the associated risks and costs. Autologous salvaged blood does not result in immunological challenge and its consequences, provides a higher quality red blood cell that has not been subjected to the adverse effects of blood storage, and can be more cost-effective than allogeneic blood when used for carefully selected surgical patients. Cardiac, orthopaedic and vascular surgery procedures with large anticipated blood loss can clearly benefit from the use of cell salvage. There are safety concerns in cases with gross bacterial contamination. There are theoretical safety concerns in obstetrical and cancer surgery; however, careful cell washing as well as leucoreduction filters makes for a safer autologous transfusion in these circumstances. Further studies are needed to determine whether oncologic outcomes are impacted by transfusing salvaged blood during cancer surgery. In this new era of patient blood management, where multimodal methods of reducing dependence on allogeneic blood are becoming commonplace, autologous blood salvage remains a valuable tool for perioperative blood conservation. Future studies will be needed to best determine how and when cell salvage should be utilized along with newer blood conservation measures.

In Vitro Evaluation of the Fresenius Kabi CATSmart Autotransfusion System.

Use of autotransfusion systems to collect, wash, and concentrate shed blood during surgical procedures is a widely used method for reducing postoperative anemia and the need for blood transfusions. The aim of this study was to evaluate the CATSmart Continuous Autotransfusion System wash program performance with small (200 or 700 mL) and large volumes (1,000 mL) of shed blood and to determine non-inferiority of the CATSmart to the C.A.T.S plus system. Human whole blood was collected in citrate phosphate dextrose, diluted, and divided into two aliquots to be processed as a pair using the C.A.T.S plus and CATSmart systems with their corresponding wash programs: low-volume, high quality/smart, or emergency wash. Final packed red cell product was analyzed for red blood cell (RBC), white blood cell, and platelet counts; hemoglobin; hemolysis; RBC recovery rates; and elimination of albumin, total protein, and potassium. The mean hematocrit (HCT) after processing with CATSmart and C.A.T.S plus systems were 59.63% and 57.71%, respectively. The calculated overall RBC recovery rates on the CATSmart and C.A.T.S plus systems were 85.41% and 84.99%, respectively. Elimination of albumin (97.5%, 98.0%), total proteins (97.1%, 97.5%), and potassium (92.1%, 91.9%) were also calculated for the CATSmart and C.A.T.S plus systems. The CATSmart and C.A.T.S plus systems both provided a high-quality product in terms of HCT, protein elimination, and hemolysis rates across the range of tested shed blood volumes and all wash programs. The study was able to confirm the CATSmart is non-inferior to the C.A.T.S plus system.

Fat removal during cell salvage: an optimized program for a discontinuous autotransfusion device.

BACKGROUND: Fat in wound blood observed in orthopedic or cardiac surgery might pose a risk for fat embolism during blood salvage. Fat removal was optimized in the washing process. STUDY DESIGN AND METHODS: In an experimental study blood from fresh donations was adjusted to a hematocrit (Hct) of 25% and an admixture of 1.25% human tissue fat. This blood was processed with the cell salvage device XTRA in a modified program mode. Volumetric quantification of fat was performed after centrifugation of blood samples in Pasteur pipettes. From the volumes, the Hct levels and the concentrations of fat and other variables elimination rates and RBC recovery were calculated. RESULTS: Pretests showed wash volume, wash flow, and process interruptions affecting fat elimination. With the new optimized fat elimination program Pfat removal rate of fat increased to 98.5 ± 0.9% for the 225-mL bowl. The product had a mean Hct of 48.7 ± 1.2% and a RBC recovery rate of 93.5 ± 2.3%. The program conserved the high elimination rates for albumin, heparin, potassium, and free plasma hemoglobin (98.8, 99.3, 95.3, and 94.9%, respectively). Similar high fat removal was also observed with bowls of smaller size, namely, 98.1% for the 175-mL bowl and 98.2% for the 125- and the 55-mL bowls. With test blood of Hct 10% a mean fat elimination of 99.6 ± 01% was observed. CONCLUSIONS: A special program modification Pfat involving extra washing and RBC concentration steps significantly improves fat removal by the Latham bowl-based autotransfusion device XTRA, thus yielding results equivalent to the continuous cell salvage system.

Argatroban for anticoagulation of a blood salvage system - an ex-vivo study.

BACKGROUND: Blood salvage systems help to minimize intraoperative transfusion of allogenic blood. So far no data is available on the use of argatroban for anticoagulation of such systems. We conducted an ex-vivo trial to evaluate the effectiveness of three different argatroban doses as compared to heparin and to assess potential residual anticoagulant in the red cell concentrates. METHODS: With ethical approval and individual informed consent, blood of 23 patients with contraindications for use of blood salvage systems during surgery was processed by the Continuous-Auto-Transfusion-System (C.A.T.S. ® Cell Saver System, Fresenius Kabi, Bad Homburg, Germany) using 5,50 or 250 mg of argatroban or 25.000 U of heparin in 1000 ml saline for anticoagulation of the system. Emergency and high-quality washing modes were applied in random order. Patency of the system and residual amount of anticoagulants in the re-transfusion bag were measured. The collected blood was not re-infused, but only used for analysis of hematocrit, heparin and argatroban concentrations. RESULTS: Patency of the system was provided by all anticoagulants except for 3/8 cases with 5 mg of argatroban. Residual anticoagulant was found in 2/10 (20 %) heparin samples in two different patients (1 emergency and 1 high-quality washing) and in all argatroban samples. High quality washing eliminated 89-95 % and emergency washing 60-90 % of the initial argatroban concentration. Residual argatroban concentrations ranged from 55 ng ml(-1) to 6810 ng ml(-1), with initial argatroban concentrations of 5 and 250 mg, respectively. CONCLUSION: The C.A.T.S. does not reliably remove heparin and should therefore not be used in HIT patients. Anticoagulation with 50 and 250 mg argatroban, maintains the systems patency and is significantly removed during washing. In this ex-vivo study a concentration of 50 µg ml(-1) argatroban provided the best ratio of system patency and residual argatroban concentration. Additional dose-finding studies with different blood salvage systems are needed to evaluate the optimal argatroban concentration.

A Novel Centrifugation Method Using a Cell Salvage Device Offers an Alternative to the Use of Leukocyte-Depleting Filters for Autologous Blood Transfusions.

Autotransfusion protocols often use the use of costly filters, such as leukocyte-depleting filters (LDFs), to minimize reinfusion of activated leukocytes and inflammatory mediators associated with reperfusion injury (RI). LDFs are used extensively in hospital settings; however, they represent an additional capital expenditure for hospitals, as well as a constraint on the reinfusion rate of blood products for health-care providers. We compared a commonly used LDF to a novel centrifugation method employing a widely used cell salvage device. Complete blood counts and enzyme-linked immunosorbent assays (ELISAs) measuring tumor necrosis factor-α (TNF-α) and interleukin-2 (IL-2) were performed to compare the efficacy of these methodologies. The LDF removed, on average, 94% of all leukocytes, including 96% of neutrophils. The centrifugation method removed, on average, 89% of all leukocytes, including 91% of neutrophils and resulted in a highly concentrated red blood cell product. Our results suggest both methods offer equivalent leukocyte reduction. TNF-α was also comparably reduced following our novel centrifugation method and the LDF method and IL-2 levels were undetectable in all samples. These results indicate our novel centrifugation method may preclude the need for a LDF during select autotransfusion applications.

Haemoconcentration of residual cardiopulmonary bypass blood using Hemosep ®: a randomised controlled trial.

Cardiac surgery and cardiopulmonary bypass are associated with haemodilution, activation of haemostasis and blood transfusion. We undertook a randomised controlled trial that included 53 patients in order to compare autotransfusion of residual cardiopulmonary bypass blood with residual blood concentrated using the novel Hemosep(®) device. There was no difference in patients' mean (SD) haemoglobin concentration after autotransfusion of unprocessed blood compared with Hemosep; 103.5 (10.2) g.l(-1) vs 106.2 (12.4) g.l(-1), respectively, p = 0.40. The mean (SD) change in haemoglobin concentration after autotransfusion was 5.9 (5.3) g.l(-1) in the control group compared with 4.9 (6.3) g.l(-1) in the Hemosep group, p = 0.545. Adjusted for baseline haemoglobin concentrations, the estimated mean (95% CI) difference in change in haemoglobin concentration (control vs Hemosep) was 0.57 (-2.65 to 3.79) g.l(-1), p = 0.72. This was despite Hemosep's reducing the weight of the blood from a mean (SD) of 778.7 (243.0) g to 607.3 (248.2) g, p < 0.001. The haemoglobin concentration in the processed blood increased from a mean (SD) of 87.0 (15.1) g.l(-1) to 103.7 (17.4) g.l(-1), p < 0.001. We conclude that Hemosep is capable of haemoconcentration when employed to process residual cardiopulmonary bypass blood, but that this is insufficient to increase patient haemoglobin.

Processing of small volumes in blood salvage devices.

BACKGROUND: New technical developments such as a small Latham bowl, a continuous autotransfusion system, and a dynamic disk designed for postoperative autotransfusion raise hopes for a possible application of blood salvage in young children. However, the minimal blood volume for effective processing under clinically relevant conditions has yet to be determined. STUDY DESIGN AND METHODS: Fresh blood from volunteer donations adjusted to a hematocrit (Hct) of 10% was used to test ELECTA (Sorin) equipped with a 55-mL bowl, C.A.T.S (Fresenius) in the pediatric program mode, and OrthoPAT (Haemonetics). Twenty-milliliter portions of red blood cells (RBCs) were added and processed under various conditions, including clinically relevant first filling and intermittent emptying. RBC recovery and availability and plasma elimination were calculated from the Hct, free hemoglobin, and total protein. RESULTS: The main impediment to recovery and availability was the first filling. There, RBC recovery was significantly reduced, while it subsequently varied between 93 and 98%. To produce the first 30 mL of RBCs, ELECTA required 42 mL and C.A.T.S and OrthoPAT 62 mL owing to the dead space of the separation chamber or reservoir, respectively. RBC availability was much higher in subsequent processes, with only minimal differences between the three devices. They all consistently provided high plasma elimination rates. CONCLUSION: The continuous system showed no advantage over a small Latham bowl. From the results it can be calculated that the limit for feasible cell salvage at present is an infant of 6 months. All three devices are suitable for the processing of small volumes, but have the scope for further optimization.

Impact of intraoperatively salvaged and washed blood on stimulated cytokine release in vitro.

BACKGROUND: Intraoperative blood salvage and processing it with commercially available devices is a widespread standard procedure to reduce allogeneic blood transfusion in patients undergoing major orthopedic surgery. The aim of this study was to investigate the impact of such processed blood on the immune system by measuring pro- and anti-inflammatory cytokines. STUDY DESIGN AND METHODS: Salvaged blood from 20 patients undergoing hip arthroplasty was processed with a continuous autotransfusion system. One part of the processed blood was left without further treatment, one part was additionally leukoreduced, one part was irradiated, and one part was separated into its cellular and soluble fraction by centrifugation. Specimens from each part were mixed in vitro with venous blood from the patient in ratios of 3:1, 1:1, and 1:3 and incubated with endotoxin for 24 hours. Tumor necrosis factor (TNF)-α and interleukin (IL)-10 were measured in cell culture supernatants by enzyme-linked immunosorbent assay. RESULTS: All parts of the salvaged blood were without a significant influence on TNF-α release. In contrast, IL-10 was significantly increased, independently of the admixtured salvaged blood being plain, additionally irradiated, or additionally leukoreduced. This IL-10 increase was also found with the cellular fraction of the plain salvaged blood, whereas the soluble fraction had no influence on IL-10 release. CONCLUSION: Intraoperative salvaged blood is not immunologically inert. We observed a significant increase in the anti-inflammatory IL-10 response without affecting the proinflammatory TNF-α release. Neither leukofiltration nor gamma irradiation eliminated this effect that was limited only to the cellular fraction of the salvaged blood, suggesting red blood cells to be responsible for the observed immunomodulation.

Patient blood management in elective total hip- and knee-replacement surgery (Part 1): a randomized controlled trial on erythropoietin and blood salvage as transfusion alternatives using a restrictive transfusion policy in erythropoietin-eligible patients.

BACKGROUND: Patient blood management combines the use of several transfusion alternatives. Integrated use of erythropoietin, cell saver, and/or postoperative drain reinfusion devices on allogeneic erythrocyte use was evaluated using a restrictive transfusion threshold. METHODS: In a factorial design, adult elective hip- and knee-surgery patients with hemoglobin levels 10 to 13 g/dl (n = 683) were randomized for erythropoietin or not, and subsequently for autologous reinfusion by cell saver or postoperative drain reinfusion devices or for no blood salvage device. Primary outcomes were mean allogeneic intra- and postoperative erythrocyte use and proportion of transfused patients (transfusion rate). Secondary outcome was cost-effectiveness. RESULTS: With erythropoietin (n = 339), mean erythrocyte use was 0.50 units (U)/patient and transfusion rate 16% while without (n = 344), these were 0.71 U/patient and 26%, respectively. Consequently, erythropoietin resulted in a nonsignificant 29% mean erythrocyte reduction (ratio, 0.71; 95% CI, 0.42 to 1.13) and 50% reduction of transfused patients (odds ratio, 0.5; 95% CI, 0.35 to 0.75). Erythropoietin increased costs by €785 per patient (95% CI, 262 to 1,309), that is, €7,300 per avoided transfusion (95% CI, 1,900 to 24,000). With autologous reinfusion, mean erythrocyte use was 0.65 U/patient and transfusion rate was 19% with erythropoietin (n = 214) and 0.76 U/patient and 29% without (n = 206). Compared with controls, autologous blood reinfusion did not result in erythrocyte reduction and increased costs by €537 per patient (95% CI, 45 to 1,030). CONCLUSIONS: In hip- and knee-replacement patients (hemoglobin level, 10 to 13 g/dl), even with a restrictive transfusion trigger, erythropoietin significantly avoids transfusion, however, at unacceptably high costs. Autologous blood salvage devices were not effective.

Patient blood management in elective total hip- and knee-replacement surgery (part 2): a randomized controlled trial on blood salvage as transfusion alternative using a restrictive transfusion policy in patients with a preoperative hemoglobin above 13 g/dl.

BACKGROUND: Patient blood management is introduced as a new concept that involves the combined use of transfusion alternatives. In elective adult total hip- or knee-replacement surgery patients, the authors conducted a large randomized study on the integrated use of erythropoietin, cell saver, and/or postoperative drain reinfusion devices (DRAIN) to evaluate allogeneic erythrocyte use, while applying a restrictive transfusion threshold. Patients with a preoperative hemoglobin level greater than 13 g/dl were ineligible for erythropoietin and evaluated for the effect of autologous blood reinfusion. METHODS: Patients were randomized between autologous reinfusion by cell saver or DRAIN or no blood salvage device. Primary outcomes were mean intra- and postoperative erythrocyte use and proportion of transfused patients (transfusion rate). Secondary outcome was cost-effectiveness. RESULTS: In 1,759 evaluated total hip- and knee-replacement surgery patients, the mean erythrocyte use was 0.19 (SD, 0.9) erythrocyte units/patient in the autologous group (n = 1,061) and 0.22 (0.9) erythrocyte units/patient in the control group (n = 698) (P = 0.64). The transfusion rate was 7.7% in the autologous group compared with 8.3% in the control group (P = 0.19). No difference in erythrocyte use was found between cell saver and DRAIN groups. Costs were increased by €298 per patient (95% CI, 76 to 520). CONCLUSION: In patients with preoperative hemoglobin levels greater than 13 g/dl, autologous intra- and postoperative blood salvage devices were not effective as transfusion alternatives: use of these devices did not reduce erythrocyte use and increased costs.

Effects of the Sangvia blood collection system on patients undergoing elective hip surgery.

We have conducted a randomized controlled study where 164 patients were randomized to receive autologous salvaged blood collected by Sangvia™ Blood Salvage System or allogeneic red cell concentrates if transfusion was indicated by clinical judgement. The study was powered to detect if transfusion of autologous blood reduced the occurrence of postoperative infections. We found no statistical significant difference in postoperative infection rate between the groups, but this may be due to the fact that postoperative infections were diagnosed in only five patients. Increased C-reactive protein concentrations slightly above level of significance indicate that autologous blood transfusions stimulate the patient's immune system. However, there was no indication of increased transfusion reaction rate, including febrile reactions, in the autologous group. Transfusion of autologous blood did not reduce the use of allogeneic red cell concentrates. The mean use of allogeneic red cell concentrates was 0.93 units (both groups combined), indicating that the transfusion policy may have been too liberal. There was a highly significant inverse correlation between pre-operative haemoglobin concentration and transfusion of allogeneic blood. In a patient population with a low frequency of postoperative infection, a larger study is needed to clarify if autologous salvaged blood protects against postoperative infections.

Prospects for using a hemoconcentrator as an alternative hemodialysis method in cardiopulmonary bypass surgeries.

OBJECTIVE: Cardioplegic solutions often cause high blood concentrations of potassium. The conventional hemoconcentration circuit was improved to correct electrolyte imbalances through a method involving dilutional ultrafiltration (DUF) and an alternative hemodialysis (ALTHD) method. This study aimed to determine the effectiveness of this ALTHD method. METHODS: Bovine blood was used, in conjunction with a hemoconcentrator, in an experimental hemodialysis (HD) circuit to evaluate an ALTHD method. The effectiveness of the method was determined by electrolyte and hematocrit measurements following the procedure. RESULTS: The ALTHD method corrected electrolyte levels as effectively as DUF and was less affected by dilution than DUF. CONCLUSION: The ALTHD method may provide faster electrolyte adjustments than DUF because its efficiency depends on both the blood and dialysate flow rates. In addition, the ALTHD method is expected to provide increased efficiency. Thus, our DUF/ALTHD circuit-switching method may be clinically useful when rapid electrolyte correction is required.

Washing of banked blood by three different blood salvage devices.

BACKGROUND: Storage lesions in red blood cells (RBCs) lead to an accumulation of soluble contaminants that can compromise the patient. Organ failures, coagulopathies, and cardiovascular events including lethal cardiac arrest have been reported, especially with massive transfusion or in pediatric patients. Washing improves the quality of stored RBCs, and autotransfusion devices have been proposed for intraoperative processing, but these devices were designed for diluted wound blood, and limited data on their performance with RBCs are available. STUDY DESIGN AND METHODS: Three autotransfusion devices (Electa, Sorin; CATS, Fresenius; OrthoPAT, Haemonetics) differing in function of their centrifugation chambers were evaluated with RBCs at the end of their shelf life and with dilutions thereof. Elimination rates of potassium, plasma free hemoglobin, total protein, citrate, acid equivalents, and iomeprol added as a marker substance were analyzed, in addition to RBC recoveries. RESULTS: Product hematocrit (Hct) levels ranged between 54.8 and 72.6%. RBC recovery rates were between 62.7 and 95.0%, the lowest being with the OrthoPAT processing of undiluted RBCs. Plasma elimination rates increased with predilution and ranged from 46.6% to 99.5%, the lowest being with the CATS and undiluted RBCs. Washing did not change pH and buffering capacity of RBCs. CONCLUSION: Autotransfusion devices offer a practical and obviously economical option to wash banked RBCs intraoperatively to prevent hyperkalemia and other disturbances in massive transfusion or pediatric patients. Predilution improves elimination rates, especially in devices that produce high product Hct levels. With a Y-tubing the RBCs should bypass reservoir and vacuum, and the procedure should be guarded by a policy and procedure manual and a quality management system.

Reduction of allogeneic red blood cell usage during cardiac surgery by an integrated intra- and postoperative blood salvage strategy: results of a randomized comparison.

BACKGROUND: The amount of allogeneic blood transfusion may relate to worse outcome in cardiac surgery. The reinfusion of red blood cells (RBCs) lost by patients, including those of chest drains, is a promising strategy to minimize allogeneic transfusions. STUDY DESIGN AND METHODS: To verify this hypotheis, 1047 cardiac surgery patients were randomly assigned to either traditional intraoperative blood salvage followed by chest drain insertion or intra- and postoperative strategy with the Haemonetics cardioPAT system. Allogeneic RBC transfusion rate (primary endpoint) and postoperative complications (secondary endpoint) were recorded at the time of discharge from the hospital and at first month follow-up visit, respectively. RESULTS: The cardioPAT arm received 1.20 units of allogeneic RBCs per patient, whereas the control group required 2.11 units per patient, and this difference proved to be highly significant (p=0.02). We observed a comparable 45-day mortality rate but a lower rate of deep vein thrombosis (p=0.04) and atrial fibrillation (p=0.04) in the cardioPAT arm. DISCUSSION: A significant reduction in patient exposure to allogeneic RBCs was observed in the cardioPAT system arm. Complications were slightly less frequent in the cardioPAT group. The use of the cardioPAT is a safe and effective strategy to reduce allogeneic RBC transfusions in cardiac surgery.

Acute hypotension associated with intraoperative cell salvage using a leukocyte depletion filter during management of obstetric hemorrhage due to amniotic fluid embolism.

Amniotic fluid embolism (AFE) is a rare but catastrophic obstetric complication that can lead to profound coagulopathy and hemorrhage. The role of cell salvage and recombinant human Factor VIIa (rFVIIa) administration in such cases remains unclear. We present a case of AFE and describe our experience with the use of cell salvage and rFVIIa administration during the resuscitation. Cell salvage and transfusion through a leukocyte depletion filter was attempted after the diagnosis of AFE was made, but the attempted transfusion was immediately followed by hypotension and a worsening of hemodynamics. rFVIIa, on the contrary, was used with clinical improvement in coagulopathy and without apparent adverse thrombotic effect.

A laboratory study of the effects of processing blood through a cell salvage device and leucocyte depletion filter on levels of pro-inflammatory cytokines and bradykinin.

We investigated changes in concentrations of interleukin-1ß, interleukin-6, tumour necrosis factor-α and bradykinin in blood during passage through a cell salvage device and a leucocyte depletion filter, with or without application of subatmospheric pressure across the filter. Blood samples from 19 healthy women undergoing scheduled caesarean section showed concentrations of cytokines and bradykinin in blood filtered under gravity flow that were equal to or significantly lower than those of pre-operative venous blood samples. They were also significantly lower than that in postoperative orthopaedic shed blood, which is commonly reinfused after orthopaedic surgery. A minority of samples taken from blood that had been filtered using subatmospheric pressure showed raised interleukin-6 concentrations. We suggest that use of a leucocyte depletion filter for cell-salvaged blood with gravity flow is likely to be safe with regard to concentrations of cytokines and bradykinin. However, this may not hold true for the filter used with subatmospheric pressure. If transfusion of salvaged blood using a leucocyte depletion filter seems to induce hypotension, elevation of interleukin-6 should be suspected.