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Training courses for pediatric apheresis on site; how apheresis technology transfer can be performed.

机译:现场进行小儿血液分离培训课程;如何进行单采技术转让。

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摘要

Apheresis technology for pediatric patients and donors is still cumbersome, it is rare, mostly done in departments specialized for apheresis in adult patients, and therefore the staff is more or less anxious about dealing with especially little pediatric patients or donors. Our center is specialized in pediatrics and has a department for apheresis. We offered training courses for interested centers, which want to use the AMICUS system for leukapheresis in small children. In a 1-2 ay course the principles of leukapheresis in very small children were trained. To investigate the reproducibility of this training courses we invited the centers to share their data with us. As a standard we used a formula (C=[(AD):Bx0.5]:1000) for predicting the CD34+ cell yield (C) by calculating the yield from total blood volume (D) processed, bodyweight (B), CD34+ cell count in peripheral blood (A) and an assumption of the collection efficiency of 50% (0.5). We hypostasized that the deviation of different centers should be in comparable limits of agreement as our own data. Thirteen centers from Germany, Poland, Ukraine, Romania, Italy, Hungary, and Slovakia asked from 1999 until today for support for pediatric leukapheresis. 6 centers sent 20 case report forms back (9 blood priming, 6 saline priming), from which 15 were completely filled in and available for the evaluation. The data were compared to 129 leukapheresis (41 blood priming, 88 saline priming) performed in our institution. The limit of agreement to the formula was -17.6% (+/-43) compared to -10.5% (+/-36). There was no statistically differences by the Mann-Whitney-U-test (p=0.5607). We conclude that training course held on site in different centers in different country could led to reproducible performance of standardized leukapheresis procedures in small children. In the future this could be a way for quality control in pediatric apheresis.
机译:儿科患者和捐献者的剥离技术仍然很麻烦,很少见,主要是在成年患者的单采血液分离部门中完成的,因此工作人员或多或少地担心与很少的儿科患者或捐献者打交道。我们的中心专门从事儿科研究,并设有血液分离部门。我们为有兴趣的中心提供了培训课程,这些中心希望使用AMICUS系统进行小儿白细胞分离术。在1-2 ay的课程中,对很小的孩子进行了白细胞分离术的原理训练。为了调查此培训课程的可重复性,我们邀请各中心与我们共享其数据。作为标准,我们使用公式(C = [((AD):Bx0.5]:1000)通过计算来自处理的总血容量(D),体重(B),CD34 +的产量来预测CD34 +细胞的产量(C)。外周血细胞计数(A),并假设收集效率为50%(0.5)。我们假设不同中心的偏差应与我们自己的数据在可比较的一致限制范围内。从1999年到今天,来自德国,波兰,乌克兰,罗马尼亚,意大利,匈牙利和斯洛伐克的13个中心向小儿白细胞分离术寻求支持。 6个中心送回了20份病例报告表(9份血液灌注,6份生理盐水灌注),其中15份已完全填写并可供评估。将该数据与我们机构中进行的129例白细胞分离术(41次血液灌注,88次生理盐水灌注)进行比较。公式的一致性限制为-17.6%(+/- 43),而-10.5%(+/- 36)。通过Mann-Whitney-U检验没有统计学差异(p = 0.5607)。我们得出的结论是,在不同国家/地区的不同中心举行的培训课程可能会导致幼儿进行标准化白细胞分离术程序的可重复执行。将来,这可能是小儿血液分离术质量控制的一种方法。

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