Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.
Department of Internal Medicine and Cardiology, Charité University Medicine Berlin - Campus Virchow Klinikum, Berlin, Germany.
Crit Care. 2017 Feb 15;21(1):32. doi: 10.1186/s13054-017-1619-z.
Point-of-care testing (POCT) of coagulation has been proven to be of great value in accelerating emergency treatment. Specific POCT for direct oral anticoagulants (DOAC) is not available, but the effects of DOAC on established POCT have been described. We aimed to determine the diagnostic accuracy of Hemochron® Signature coagulation POCT to qualitatively rule out relevant concentrations of apixaban, rivaroxaban, and dabigatran in real-life patients.
We enrolled 68 patients receiving apixaban, rivaroxaban, or dabigatran and obtained blood samples at six pre-specified time points. Coagulation testing was performed using prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (aPTT), and activated clotting time (ACT+ and ACT-low range) POCT cards. For comparison, laboratory-based assays of diluted thrombin time (Hemoclot) and anti-Xa activity were conducted. DOAC concentrations were determined by liquid chromatography-tandem mass spectrometry.
Four hundred and three samples were collected. POCT results of PT/INR and ACT+ correlated with both rivaroxaban and dabigatran concentrations. Insufficient correlation was found for apixaban. Rivaroxaban concentrations at <30 and <100 ng/mL were detected with >95% specificity at PT/INR POCT ≤1.0 and ≤1.1 and ACT+ POCT ≤120 and ≤130 s. Dabigatran concentrations at <30 and <50 ng/mL were detected with >95% specificity at PT/INR POCT ≤1.1 and ≤1.2 and ACT+ POCT ≤100 s.
Hemochron® Signature POCT can be a fast and reliable alternative for guiding emergency treatment during rivaroxaban and dabigatran therapy. It allows the rapid identification of a relevant fraction of patients that can be treated immediately without the need to await the results of much slower laboratory-based coagulation tests.
Unique identifier, NCT02371070 . Retrospectively registered on 18 February 2015.
床边凝血检测（POCT）已被证明在加速急诊治疗方面具有重要价值。目前尚无针对直接口服抗凝剂（DOAC）的特定 POCT，但已描述了 DOAC 对已建立的 POCT 的影响。我们旨在确定 Hemochron®Signature 凝血 POCT 定性排除现实生活中接受阿哌沙班、利伐沙班和达比加群相关浓度的诊断准确性。
我们招募了 68 名接受阿哌沙班、利伐沙班或达比加群治疗的患者，并在六个预定时间点采集血液样本。使用凝血酶原时间/国际标准化比值（PT/INR）、活化部分凝血活酶时间（aPTT）和活化凝血时间（ACT+和 ACT-low 范围）POCT 卡进行凝血检测。为了比较，还进行了基于实验室的稀释凝血酶时间（Hemoclot）和抗-Xa 活性测定。通过液相色谱-串联质谱法测定 DOAC 浓度。
共采集 403 个样本。PT/INR 和 ACT+ 的 POCT 结果与利伐沙班和达比加群的浓度相关。阿哌沙班的相关性不足。在 PT/INR POCT≤1.0 和≤1.1 以及 ACT+ POCT≤120 和≤130 s 时，检测到<30 和<100 ng/mL 的利伐沙班浓度的特异性>95%。在 PT/INR POCT≤1.1 和≤1.2 以及 ACT+ POCT≤100 s 时，检测到<30 和<50 ng/mL 的达比加群浓度的特异性>95%。
Hemochron®Signature POCT 可以成为利伐沙班和达比加群治疗期间快速可靠的替代方法，指导急诊治疗。它可以快速识别出大量需要立即治疗的患者，而无需等待更慢的基于实验室的凝血检测结果。
唯一标识符，NCT02371070。于 2015 年 2 月 18 日回顾性注册。
