Jaryno Stacy A, Zucker Marcia L, LaDuca Frank M
Clinical Affairs, International Technidyne Corporation, Edison, New Jersey, USA.
J Extra Corpor Technol. 2004 Sep;36(3):258-62.
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.
在心脏手术期间,使用剂量测定法来计算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的总体预后。当采用个体化给药系统管理患者时,术中及术后的输血需求和出血量会减少。Hemochron RxDx系统被广泛用作传统活化凝血时间检测的补充手段,以优化抗凝管理。该系统由肝素反应测试、鱼精蛋白反应测试和鱼精蛋白剂量测定组成。所有这些都是对活化凝血时间的改良,使用硅藻土(硅藻土公司,加利福尼亚州圣巴巴拉)或高岭土作为激活剂。使用早期版本的Hemochron仪器(801型)手动计算剂量,或者使用Hemochron 8000自动计算剂量,也可使用Hemochron Response的早期版本和个人数字助理(PDA)RxDx计算器自动计算剂量。现有的用户选项中缺少用于Response的自动化RxDx系统。在四个临床地点进行了一项研究,以比较最近开发的Response RxDx软件(该软件不再需要PDA RxDx计算器)与现有的Hemochron 8000 RxDx以及Response - PDA RxDx系统。与当前系统类似,操作人员输入患者的身高、体重和性别,软件会自动计算血容量。利用在Response上测定的凝血时间,自动计算肝素和鱼精蛋白的推注剂量以及任何额外的肝素和鱼精蛋白需求。收集了76例患者的数据,其中64例患者使用体外循环,11例患者未使用体外循环,1例患者从非体外循环转换为体外循环。与现有系统相比,Response估算血容量的计算显示相关系数为0.989。推注肝素(r = 0.925)和鱼精蛋白剂量(r = 0.900)也观察到良好的相关性,配对学生t检验证实了两者的等效性。这些数据证实,Response RxDx系统产生的结果与使用Hemochron 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更多用户选项、用于预设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。Hemochron Response RxDx代表了一种针对心脏手术患者的完整抗凝管理系统。