Combined Platelet and Erythrocyte Salvage: Evaluation of a New Filtration-based Autotransfusion Device

Abstract

Background The SAME device (i-SEP, France) is an innovative filtration-based autotransfusion device able to salvage and wash both red blood cells and platelets. This study evaluated the device performances using human whole blood with the hypothesis that the device will be able to salvage platelets while achieving a erythrocyte yield of 80% and removal ratios of 90% for heparin and 80% for major plasma proteins without inducing signification activation of salvaged cells. Methods Thirty healthy human whole blood units (median volume, 478 ml) were diluted, heparinized, and processed by the device in two consecutive treatment cycles. Samples from the collection reservoir and the concentrated blood were analyzed. Complete blood count was performed to measure blood cell recovery rates. Flow cytometry evaluated the activation state and function of platelets and leukocytes. Heparin and plasma proteins were measured to assess washing performance. Results The global erythrocyte yield was 88.1% (84.1 to 91.1%; median [25th to 75th]) with posttreatment hematocrits of 48.9% (44.8 to 51.4%) and 51.4% (48.4 to 53.2%) for the first and second cycles, respectively. Ektacytometry did not show evidence of erythrocyte alteration. Platelet recovery was 36.8% (26.3 to 43.4%), with posttreatment counts of 88 × 109/l (73 to 101 × 109/l) and 115 × 109/l (95 to 135 × 109/l) for the first and second cycles, respectively. Recovered platelets showed a low basal P-selectin expression at 10.8% (8.1 to 15.2%) and a strong response to thrombin-activating peptide. Leukocyte yield was 93.0% (90.1 to 95.7%) with no activation or cell death. Global removal ratios were 98.3% (97.8 to 98.9%), 98.2% (96.9 to 98.8%), and 88.3% (86.6 to 90.7%) for heparin, albumin, and fibrinogen, respectively. The processing times were 4.4 min (4.2 to 4.6 min) and 4.4 min (4.2 to 4.7 min) for the first and second cycles, respectively. Conclusions This study demonstrated the performance of the SAME device. Platelets and red blood cells were salvaged without significant impact on cell integrity and function. In the meantime, leukocytes were not activated, and the washing quality of the device prevented reinfusion of high concentrations of heparin and plasma proteins. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

A novel autotransfusion device saving erythrocytes and platelets used in a 72 h survival swine model of surgically induced controlled blood loss

“…Indeed, the obtained treatment rate was higher than 80 mL/min, which is faster than the rate encountered by machines treating blood per centrifugation, even when using the emergency mode [59], and allowed the treatment of 500 mL to 700 mL diluted shed blood in less than 6 minutes. Moreover, platelet yield was always greater than 40% and higher than that obtained in the preliminary in vitro study of i-SEP using human blood [30]. Platelet concentration yields with the i-SEP device is higher than the ones that are usually observed with devices using centrifugation as a concentration method in in vitro and in vivo studies [59].…”

“…The reinfusion of platelets is considered as a potential prothrombotic risk. However, it was shown that the i-SEP autotransfusion system does not activate platelets during the treatment, and that platelets keep their ability to be activated after the treatment [30]. However, platelet activation was not evaluated in this animal study.…”

“…The RBCs sensitivity to hemolysis has two consequences when compared to human blood treatment: hemolysis in the treated blood is higher and RBCs yield is lower. Indeed, in a preliminary in vitro study testing the system with human blood, RBC yield was over 88.1% and the final hemolysis was 0.12% [30]. A comparative study in swine with a system already available would allow confirmation of the fragility of porcine RBCs under these conditions and would rule out a specific impact of the i-SEP device.…”

“…The treatment set consists mainly of tubings, a hollow fiber cartridge to separate blood cells from plasma, a blood treatment bag that ensures blood washing, a waste bag collecting plasma and contaminants, and a reinfusion bag to store filtered, washed and concentrated blood. A more detailed processing is described elsewhere [30].…”

“…The device integrates an innovative filtration technology through hollow fibers, allowing RBCs concentration but also platelets within the concentrated blood product and contaminant elimination. A preliminary in vitro study demonstrated the ability to efficiently wash and concentrate red blood cells, white blood cells and platelets without significant impact on cell integrity and function [30]. The dual objective of this study was first to develop a swine surgical model of controlled blood loss with a 72-hour post-operative follow-up, and then to evaluate the use of the autotransfusion device in this swine model.…”