Arends Sven, Thomas Michael, Nosch Michael, Droll Thomas, Zwanziger Denise, Brenner Thorsten, Haddad Ali
Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Department of Anesthesiology, Intensive Care Medicine, and Pain Therapy, Marien Hospital Bottrop gGmbH, Bottrop, Germany.
Transfus Med Hemother. 2024 Apr 2;51(6):367-372. doi: 10.1159/000536322. eCollection 2024 Dec.
The use of cell salvage and autologous blood transfusion is an important and widespread method of blood conservation during surgeries with expected high blood loss. The continuous autotransfusion device CATSmart (Fresenius Kabi, Germany) contains two new washing programs on the device called Flex wash 3 and Flex wash 5. To the best of our knowledge, there are no published clinical data regarding the performance of the two new washing programs.
In total, 69 patients undergoing cardiac or orthopedic surgery were included in this randomized, controlled, bicentric trial to validate the red cell separation process and washout quality of Flex wash 3 compared to Flex wash 5. After washing, the primary quality target was to determine hematocrit value, recovery rate, albumin, and total protein elimination rate in the packed red cells (PRCs). The secondary objective was to assess the elimination of heparin by measuring the factor anti-Xa activity by a 1- and 2-stage assay in PRC after washing.
In the whole cohort of patients, hematocrit was 16.00% [9.15%; 21.30%] (median [Q1; Q3]) in the wound blood and 69.90% [51.10%; 80.90%] in the PRC resulting in a recovery rate of 63.92% [47.06%; 88.13%]. The albumin elimination rate was 98.77% [97.94%; 99.27%], and the total protein elimination rate was 98.85% [97.76%; 99.42%]. The heparin elimination rate was 99.95% [99.90%; 99.97%] in the 1-stage assay and 99.70% [99.41%; 99.87%] in the 2-stage assay. There was no difference between Flex wash 3 and Flex wash 5 washing procedure regarding the recovery rate 63.75% [46.64%; 78.65%] versus 67.89% [47.20%; 92.69%] ( = 0.85), albumin elimination rate 98.74% [97.67%; 99.27%] versus 98.78% [98.10%; 99.28%] ( = 0.97), protein elimination rate 98.79% [97.94%; 99.47%] versus 98.92% [97.58%; 99.42%] ( = 0.88), and anti-Xa elimination rate in the 1-stage assay 99.94% [99.79%; 99.97%] versus 99.95% [99.92%; 99.97%] ( = 0.24) and in 2-stage assay 99.66% [99.20%; 99.86%] versus 99.77% [99.47%; 99.90%] ( = 0.23).
The two new washing procedures, Flex wash 3 and Flex wash 5, enable sufficient and comparable red cell separation and washout quality of albumin, total protein, as well as heparin.
细胞回收和自体输血的应用是预计失血量大的手术中一种重要且广泛使用的血液保护方法。连续自动输血装置CATSmart（德国费森尤斯卡比公司）在设备上包含两个新的清洗程序，称为Flex wash 3和Flex wash 5。据我们所知，尚无关于这两个新清洗程序性能的已发表临床数据。
本随机、对照、双中心试验共纳入69例接受心脏或骨科手术的患者，以验证Flex wash 3与Flex wash 5相比的红细胞分离过程和洗脱质量。清洗后，主要质量指标是测定浓缩红细胞（PRC）中的血细胞比容值、回收率、白蛋白和总蛋白清除率。次要目标是通过在清洗后的PRC中进行1期和2期测定来测量抗Xa因子活性，以评估肝素的清除情况。
在整个患者队列中，伤口血液中的血细胞比容为16.00%[9.15%；21.30%]（中位数[Q1；Q3]），PRC中的血细胞比容为69.90%[51.10%；80.90%]，回收率为63.92%[47.06%；88.13%]。白蛋白清除率为98.77%[97.94%；99.
