CARDIOPULMONARY BYPASS , MYOCARDIAL MANAGEMENT , AND SUPPORT TECHNIQUES MEASUREMENT OF HEPARIN CONCENTRATION IN WHOLE BLOOD WITH THE HEPCON / HMS DEVICE DOES NOT AGREE WITH LABORATORY DETERMINATION OF PLASMA HEPARIN CONCENTRATION USING A CHROMOGENIC SUBSTRATE FOR ACTIVATED FACTOR X

CARDIOPULMONARY BYPASS , MYOCARDIAL MANAGEMENT , AND SUPPORT TECHNIQUES MEASUREMENT OF HEPARIN CONCENTRATION IN WHOLE BLOOD WITH THE HEPCON / HMS DEVICE DOES NOT AGREE WITH LABORATORY DETERMINATION OF PLASMA HEPARIN CONCENTRATION USING A CHROMOGENIC SUBSTRATE FOR ACTIVATED FACTOR X
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体外循环、心肌管理和支持技术 使用 Hepcon/HMS 装置测量全血中的肝素浓度与使用显色底物激活因子 X 的实验室测定血浆肝素浓度不一致

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发表时间:
2004
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影响因子:
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通讯作者:
Frcpc Jean Perrault
Frcpc Jean Perrault
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文献类型:
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作者:
Jean;Sylvain Bdlisle;Danielle Robitaille;Frcpc Jean Perrault

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Jean-Francois Hardy,医学博士,FRCPC Sylvain Bdlisle,医学博士,FRCPC Danielle Robitaille,医学博士,FRCPC Jean Perrault,博士 Micheline Roy,RT Line Gagnon,RT 建议测量循环肝素浓度以优化体外循环期间的抗凝作用。 Hepcon/HMS 装置(Medtronic HemoTec, Inc., Parker, Colo.)使用肝素/鱼精蛋白滴定来定量测定肝素浓度。该仪器仍缺乏广泛的验证。方法:在 16 名接受心脏手术的患者中评估了 Hepcon/HMS 系统测量的肝素浓度与实验室测定的肝素浓度之间的一致性。对于实验室测定,血浆肝素浓度是通过显色底物技术测量抗 Xa 活性而得出的。 Hepcon/HMS 仪器和试剂盒测量全血肝素浓度。在施用肝素后 5 分钟、体外循环开始后 15 和 30 分钟、主动脉松开后 5 分钟、体外循环结束时以及施用鱼精蛋白后对样品进行分析。根据 Bland 和 Altman 的方法绘制和解释数据:首先,选择小于 1.4 U/ml(即 ---0.7 U/ml)的差异为可接受的,因为它不会对临床解释造成重大困难;其次,根据两种测量方法的平均值绘制两种测量技术之间的差异。结果:Hepcon/HMS 装置得出的肝素浓度与实验室测定获得的肝素浓度之间的平均差异(偏差)与对全血与血浆进行的测量的预期一致(1.45 U/ml)。然而,Hepcon/HMS 装置得出的肝素浓度可能比实验室测量的浓度高 2.76 U/ml 或低 6.17 U/ml,差异远远超出了预定的一致限度,对于临床目的来说显然是不可接受的。结论:我们得出结论,使用 Hepcon/HMS 仪器测定的肝素浓度与实验室测定的肝素浓度不一致。不建议在旁路期间使用 Hepcon/HMS 设备监测肝素浓度。 (胸心血管外科杂志 1996 年;112:154-61)
Jean-Francois Hardy, MD, FRCPC Sylvain Bdlisle, MD, FRCPC Danielle Robitaille, MD, FRCPC Jean Perrault, PhD Micheline Roy, RT Line Gagnon, RT Measurement of circulating heparin concentration has been suggested to optimize anticoagulation during cardiopulmonary bypass. The Hepcon/HMS device (Medtronic HemoTec, Inc., Parker, Colo.) uses heparin/protamine titration to quantitatively determine heparin concentration. Extensive validation of this instrument is still lacking. Methods: Agreement between heparin concentrations measured by the Hepcon/HMS system and by laboratory determination was evaluated in 16 patients undergoing cardiac operations. For laboratory determinations, plasma heparin concentration was derived from the measure of anti-Xa activity by means of a chromogenic substrate technique. The Hepcon/HMS instrument and cartridges measured whole blood heparin concentration. Samples were analyzed 5 minutes after administration of heparin, 15 and 30 minutes after the start of cardiopulmonary bypass, 5 minutes after aortic unclamping, at the end of cardiopulmonary bypass, and after administration of protamine. Data were plotted and interpreted according to the method of Bland and Altman: First, a difference less than 1.4 U/ml (i.e., ---0.7 U/ml) was chosen as acceptable, because it would not cause major difficulties in clinical interpretation; second, the difference between the two measurement techniques was plotted against the mean of the two measures. Results: The mean difference (bias) between heparin concentrations derived by the Hepcon/HMS device and those obtained by laboratory determination was as expected for measures performed on whole blood versus plasma (1.45 U/ml). Nevertheless, heparin concentrations derived by the Hepcon/HMS device may be as much as 2.76 U/ml above or 6.17 U/ml below the concentrations measured in the laboratory, differences well outside the predetermined limits of agreement and clearly unacceptable for clinical purposes. Conclusion: We conclude that heparin concentrations determined with the Hepcon/HMS instrument do not agree with laboratory determination of heparin concentration. Monitoring of heparin concentrations during bypass with the Hepcon/HMS device cannot be recommended. (J Thorac Cardiovasc Surg 1996;112:154-61)