Fricke W, Kouides P, Kessler C, Schmaier A H, Krijanovski Y, Jagadeesan K, Joist J
Department of Internal Medicine, Georgetown University, Washington, DC, USA.
J Thromb Haemost. 2004 May;2(5):763-8. doi: 10.1111/j.1538-7836.2004.00695.x.
The Clot Signature Analyzer (CSA) was designed to assess global hemostasis as a screening assay using non-anticoagulated whole blood. Three different measurements are produced by the instrument: platelet hemostasis time (PHT), clot time (CT), and collagen-induced thrombus formation (CITF).
The purpose of the present study was to determine normal ranges for these measurements and assess the performance of the CSA in patients with well-characterized hemostatic disorders and in normal subjects.
Four institutions participated in the study. Each established their own normal reference ranges. Patients with well-characterized hemostatic disorders and concurrent normal controls were subsequently examined.
Normal ranges between institutions were similar although statistically different. One hundred and eight patients were examined: 46 individuals with von Willebrand disease (VWD) (type 1, 26; type 2A, 11; type 2B, six; type 3, three); 38 patients with a coagulation factor deficiency; 13 individuals with platelet function defects; 10 patients taking warfarin; and one individual on low-molecular-weight heparin. Of these patients, 89% had at least one abnormality by CSA: 42/46 VWD patients, 35/38 coagulation protein defect patients, 9/13 patients with platelet function defects, 9/10 patients on warfarin and 1/1 patient on low-molecular-weight heparin. Of 116 normal subjects, 103 (89%) fell within the centers' normal range. These data suggest that the CSA has a good sensitivity for bleeding disorders.
凝块特征分析仪（CSA）旨在使用非抗凝全血作为筛查检测来评估整体止血情况。该仪器可产生三种不同的测量结果：血小板止血时间（PHT）、凝血时间（CT）和胶原诱导血栓形成（CITF）。
本研究的目的是确定这些测量结果的正常范围，并评估CSA在具有明确止血障碍的患者和正常受试者中的性能。
四家机构参与了该研究。每家机构都建立了自己的正常参考范围。随后对具有明确止血障碍的患者及同期正常对照进行了检查。
各机构之间的正常范围相似，尽管在统计学上存在差异。共检查了108例患者：46例血管性血友病（VWD）患者（1型26例；2A型11例；2B型6例；3型3例）；38例凝血因子缺乏患者；13例血小板功能缺陷患者；10例服用华法林的患者；以及1例使用低分子量肝素的患者。在这些患者中，89%的患者通过CSA检测至少有一项异常：46例VWD患者中有42例，38例凝血蛋白缺陷患者中有35例，13例血小板功能缺陷患者中有9例，10例服用华法林的患者中有9例，1例使用低分子量肝素的患者中有1例。在116名正常受试者中，103名（89%）在各中心的正常范围内。这些数据表明CSA对出血性疾病具有良好的敏感性。
