The Hemochron® Response RxDx® Heparin and Protamine Dosing System

Stacy A. Jaryno, M. Zucker, F. Laduca
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Abstract

The use of dosing assays to calculate heparin and protamine dose requirements during cardiac surgery has been shown to significantly improve overall postoperative patient outcome. When patients are managed with an individualized dosing system, intraoperative and postoperative transfusion requirements and bleeding are reduced. The Hemochron® RxDx® system is widely used as a complement to traditional activated clotting time testing to optimize anticoagulation management. The system consists of the heparin response test, the protamine response test, and the protamine dose assay. All are modifications of the activated clotting time using either Celite® (Celite Corporation, Santa Barbara, CA) or kaolin as the activator. Dosing is calculated manually using earlier version Hemochron instruments (model 801) or automatically with the Hemochron 8000 or with the early versions of the Hemochron® Response and the personal digital assistant (PDA) RxDx calculator. Missing from available user options is an automated RxDx system for the Response. A study was conducted at four clinical sites to compare recently developed Response RxDx software, which eliminates the need for the PDA RxDx calculator, to the existing Hemochron 8000 RxDx and to the Response-PDA RxDx systems. Similar to the current system, the operator inputs the patient’s height, weight, and gender, and the software automatically calculates the blood volume. Using the clotting times determined on the Response, bolus heparin and protamine doses and any additional heparin and protamine requirements are calculated automatically. Data were collected from 76 patients, of which, 64 patients were on pump, 11 patients were off pump, and 1 patient was converted from off to on pump. The Response estimated blood volume calculations showed a correlation coefficient of 0.989 when compared with available systems. A good correlation was also observed for the bolus heparin (r = 0.925) and protamine doses (r = 0.900) with equivalence confirmed by a paired student’s t test. These data confirm that the Response RxDx system yields results that are identical (P > 0.05) to those obtained using the Hemochron 8000 RxDx or Response-PDA RxDx calculator. The Response RxDx also offers expanded user options related to blood volume limits, expanded clotting time ranges for presetting default values, and flexibility in test sequence. Case records can be printed or downloaded to a PC via the HRDM data management program. The Hemochron Response RxDx represents a complete anticoagulation management system for the cardiac surgical patient.
hemchron®Response RxDx®肝素和鱼精蛋白给药系统
使用剂量测定法计算心脏手术期间肝素和鱼精蛋白的剂量需求已被证明可显著改善患者术后总体预后。当患者采用个体化给药系统时,术中和术后输血需求和出血减少。haemchron®RxDx®系统被广泛用作传统活化凝血时间测试的补充,以优化抗凝管理。该系统由肝素反应试验、鱼精蛋白反应试验和鱼精蛋白剂量试验组成。所有这些都是使用Celite®(Celite Corporation, Santa Barbara, CA)或高岭土作为活化剂来改变活化凝血时间。使用早期版本的hemchron仪器(型号801)手动计算剂量,或使用hemchron 8000或早期版本的hemchron®Response和个人数字助理(PDA) RxDx计算器自动计算剂量。可用的用户选项中缺少用于响应的自动RxDx系统。在四个临床站点进行了一项研究,比较了最近开发的Response RxDx软件,该软件消除了对PDA RxDx计算器的需求,与现有的Hemochron 8000 RxDx和Response-PDA RxDx系统。与目前的系统类似,操作者输入病人的身高、体重和性别,软件自动计算出血容量。根据反应测定的凝血时间,自动计算肝素和鱼精蛋白剂量以及任何额外的肝素和鱼精蛋白需要量。收集76例患者的数据,其中64例患者使用泵,11例患者停用泵,1例患者由停泵转为开泵。与现有系统相比,响应估计血容量计算的相关系数为0.989。肝素剂量(r = 0.925)与鱼精蛋白剂量(r = 0.900)也有良好的相关性,并通过配对学生t检验证实了等效性。这些数据证实,Response RxDx系统产生的结果与使用hemchron 8000 RxDx或Response- pda RxDx计算器获得的结果相同(P > 0.05)。Response RxDx还提供了与血容量限制相关的扩展用户选项,预置默认值的扩展凝血时间范围,以及测试顺序的灵活性。病例记录可以通过HRDM数据管理程序打印或下载到个人电脑。RxDx为心脏手术患者提供了一套完整的抗凝管理系统。
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