Department of Haematology and Transfusion Medicine, National Centre of Haemostasis and Thrombosis, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, Martin, Slovakia.
First Department of Internal Medicine, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, Martin, Slovakia.
Clin Appl Thromb Hemost. 2021 Jan-Dec;27:1076029620983902. doi: 10.1177/1076029620983902.
A rapid and reliable assessment of the dabigatran effect is desirable in dabigatran treated patients with uncontrolled bleeding or before acute surgery. The aim of this study was to study the anticoagulant effects of dabigatran in patients with atrial fibrillation (AF) as assessed by the whole blood assays ROTEM, and how data from these methods correlate to plasma dabigatran concentrations measured by Hemoclot. ROTEM was performed with ROTEM Gamma (Pentapharm GmbH, Munich, Germany). The assays used in our study were Ex-tem and In-tem assay. Plasma dabigatran concentrations were determined by hemoclot thrombin inhibitor assay (Hyphen BioMed, France) at trough and post-dose in 27 patients on dabigatran 150 mg BID. Median plasma dabigatran concentrations at trough were 74 ng/mL (11.2-250) and post-dose (2 h after ingestion) 120 ng/mL (31-282). The ROTEM clotting time (CT) and maximum clot firmnes (MCF) correlated strongly with dabigatran concentrations when activated with the reagents Ex-tem (p < 0.0001) and In-tem (p < 0.0001). In summary, in our study, we have found that the ROTEM variable CT and MCF, when activated with triggers Ex-tem and In-tem, has a strong and highly significant correlation with the plasma dabigatran concentration in a real-life population of AF-patients and could thereby be an alternative to estimate dabigatran concentration in emergency situations. However, additional studies are needed to further validate these findings.
在接受达比加群治疗且有未控制出血或需进行急性手术的患者中，需要快速可靠地评估达比加群的作用。本研究旨在通过全血检测 ROTEM 评估房颤（AF）患者的达比加群抗凝效果，并研究这些方法的数据与用 Hemoclot 测量的血浆达比加群浓度的相关性。ROTEM 使用 ROTEM Gamma（Pentapharm GmbH，慕尼黑，德国）进行。我们的研究中使用的检测方法为 Ex-tem 和 In-tem 检测。在 27 名接受达比加群 150 mg BID 治疗的患者中，在谷值和给药后 2 小时用 Hemoclot 凝血酶抑制剂检测（Hyphen BioMed，法国）测定血浆达比加群浓度。谷值时的中位血浆达比加群浓度为 74ng/ml（11.2-250），给药后（摄入后 2 小时）为 120ng/ml（31-282）。当用 Ex-tem 试剂（p < 0.0001）和 In-tem 试剂（p < 0.0001）激活时，ROTEM 凝血时间（CT）和最大凝块硬度（MCF）与达比加群浓度密切相关。总之，在我们的研究中，我们发现，当用 Ex-tem 和 In-tem 激活时，ROTEM 变量 CT 和 MCF 与 AF 患者真实人群中的血浆达比加群浓度具有很强的高度显著相关性，因此可作为在紧急情况下估计达比加群浓度的替代方法。然而，需要进一步的研究来进一步验证这些发现。
