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无乙醇自体凝血酶系统。

An Ethanol-Free Autologous Thrombin System.

作者信息

Matuska Andrea M, Klimovich Marina K, Chapman John R

机构信息

Arthrex, Inc., Naples, Florida; and.

出版信息

J Extra Corpor Technol. 2018 Dec;50(4):237-243.

Abstract

Thrombin is a coagulation protein of central importance to hemostasis and wound healing that can be sourced from human blood, bovine blood, and engineered cell lines. Only autologous thrombin lacks the risks of transmitting emergent pathogens or eliciting an immunogenic response. Previous commercial autologous thrombin devices require the use of high concentrations of ethanol to achieve thrombin stability, introducing cytotoxicity risks. A new point of care device for preparing an ethanol-free autologous thrombin serum was investigated. The ethanol-free autologous serum (AS) was prepared using the Thrombinator System (Arthrex, Inc., Naples, FL). A total of 120 devices were tested with the blood of 30 healthy donors to determine the reliability and flexibility of the procedure. AS was prepared from both whole blood (WB) and platelet-poor plasma (PPP). Study endpoints were thrombin activity determined using a coagulation analyzer and formation of cohesive bone graft composites objectively measured using a durometer. The average thrombin activity produced by this system from 24 donors was 20.6 ± 2.7 IU/mL for WB and 13.4 ± 3.8 IU/mL for PPP which correlated to clot times of 3.9 and 5.9 seconds, respectively. The device tolerated use of varying volumes of blood to prepare AS. In addition, the system was able to generate four successive and comparable AS productions. When combined with platelet-rich plasma and bone graft material, cohesive scaffolds were always formed. A new device and method for preparing single donor, ethanol-free, AS with thrombin activity was demonstrated.

摘要

凝血酶是一种对止血和伤口愈合至关重要的凝血蛋白,可从人血、牛血和工程细胞系中获取。只有自体凝血酶没有传播新兴病原体或引发免疫原性反应的风险。以前的商业自体凝血酶装置需要使用高浓度乙醇来实现凝血酶的稳定性,这带来了细胞毒性风险。研究了一种用于制备无乙醇自体凝血酶血清的新型即时护理设备。使用凝血酶生成系统(Arthrex公司,佛罗里达州那不勒斯)制备无乙醇自体血清(AS)。总共用30名健康供体的血液测试了120个设备,以确定该程序的可靠性和灵活性。AS由全血(WB)和少血小板血浆(PPP)制备。研究终点是使用凝血分析仪测定的凝血酶活性,以及使用硬度计客观测量的粘性骨移植复合材料的形成。该系统从24名供体产生的平均凝血酶活性,WB为20.6±2.7 IU/mL,PPP为13.4±3.8 IU/mL,分别对应于3.9秒和5.9秒的凝血时间。该设备能够耐受使用不同体积的血液来制备AS。此外,该系统能够连续产生四次且效果相当的AS。当与富血小板血浆和骨移植材料结合时,总能形成粘性支架。展示了一种用于制备具有凝血酶活性的单供体、无乙醇AS的新设备和方法。

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