Henriette Røed-Undlien, Nina Haagenrud Schultz, Erik Koldberg Amundsen, Birgit M. Wollmann, Espen Molden, Rupali R. Akerkar, Johannes Lagethon Bjørnstad
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We wanted to study whether hemolysis would increase apixaban concentration and investigate the impact of hemolytic interference on apixaban concentration measurements.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Blood samples from 20 apixaban-treated patients and 8 healthy controls were hemolyzed in vitro by a freeze method. The degree of hemolysis was measured with plasma free hemoglobin (PfHb) at baseline and two levels of hemolysis. Apixaban concentration was measured in plasma using both the chromogenic anti-Xa method and the ultraperformance liquid chromatography mass spectrometry (UPLC-MS). Thrombin generation assay was performed to assess coagulability.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>UPLC-MS measurements showed a mean concentration change of −1.66% (±3.2%, <i>p</i> = 0.005) and anti-Xa assay showed a mean concentration change of 3.37% (±6.5%, <i>p</i> = 0.09) with increasing hemolysis. Thrombin generation lagtime decreased, and endogenous thrombin potential and peak thrombin increased with increasing hemolysis in both the control group and the apixaban group.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Apixaban concentration measurements by anti-Xa assay and UPLC-MS were not affected by hemolysis to a clinically relevant extent. 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引用次数: 0
摘要
导言溶血干扰可能会影响各种实验室检测，包括凝血分析。阿哌沙班是挪威最常用的直接口服抗凝剂，目前还不清楚溶血会如何影响阿哌沙班的浓度测量。此外，溶血引起的阿哌沙班浓度变化可能会影响特定临床情况下的出血风险。我们希望研究溶血是否会增加阿哌沙班的浓度，并调查溶血干扰对阿哌沙班浓度测量的影响：方法：采用冷冻法对 20 名阿哌沙班治疗患者和 8 名健康对照者的血样进行体外溶血。用血浆游离血红蛋白（PfHb）测量基线和两个溶血水平的溶血程度。血浆中的阿哌沙班浓度采用显色抗 Xa 法和超高效液相色谱质谱法（UPLC-MS）进行测定。进行凝血酶生成测定以评估凝血能力：超高效液相色谱-质谱测定显示，随着溶血量的增加，平均浓度变化为-1.66%（±3.2%，p = 0.005），抗 Xa 检测显示平均浓度变化为 3.37%（±6.5%，p = 0.09）。对照组和阿哌沙班组随着溶血量的增加，凝血酶生成滞后时间减少，内源性凝血酶潜能和凝血酶峰值增加：通过抗 Xa 检测法和超高效液相色谱-质谱法测量的阿哌沙班浓度不会受到溶血的临床影响。此外，通过凝血酶生成评估溶血并不会导致低凝状态。
Does in vitro hemolysis affect measurements of plasma apixaban concentration by UPLC-MS and anti-Xa assay?
Introduction
Hemolytic interference may impact various laboratory tests, including coagulation analyses. Apixaban is the most commonly used direct oral anticoagulant in Norway, and there is lacking knowledge on how apixaban concentration measurements might be influenced by hemolysis. Moreover, hemolysis-induced alterations in apixaban levels could potentially impact the risk of bleeding in specific clinical scenarios. We wanted to study whether hemolysis would increase apixaban concentration and investigate the impact of hemolytic interference on apixaban concentration measurements.
Methods
Blood samples from 20 apixaban-treated patients and 8 healthy controls were hemolyzed in vitro by a freeze method. The degree of hemolysis was measured with plasma free hemoglobin (PfHb) at baseline and two levels of hemolysis. Apixaban concentration was measured in plasma using both the chromogenic anti-Xa method and the ultraperformance liquid chromatography mass spectrometry (UPLC-MS). Thrombin generation assay was performed to assess coagulability.
Results
UPLC-MS measurements showed a mean concentration change of −1.66% (±3.2%, p = 0.005) and anti-Xa assay showed a mean concentration change of 3.37% (±6.5%, p = 0.09) with increasing hemolysis. Thrombin generation lagtime decreased, and endogenous thrombin potential and peak thrombin increased with increasing hemolysis in both the control group and the apixaban group.
Conclusion
Apixaban concentration measurements by anti-Xa assay and UPLC-MS were not affected by hemolysis to a clinically relevant extent. Furthermore, hemolysis did not lead to hypocoagulability when assessed by thrombin generation.
期刊介绍：
The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology.
The journal publishes invited reviews, full length original articles, and correspondence.
The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines.
The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.
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