Synergistic effects of rivaroxaban and hypothermia or acidosis on coagulation initiation measured with ROTEM^®: a prospective observational study.

IF 2.6 4区医学 Q2 HEMATOLOGY

Thrombosis Journal Pub Date : 2024-10-18 DOI:10.1186/s12959-024-00661-0

Lotta Sunnersjö, Isak Ymén, Ulf Schött, Andreas Hillarp, Johan Undén, Thomas Kander

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引用次数: 0

Abstract

Background: Hypothermia and acidosis individually inhibit haemostasis. We designed this study with the aim to investigate whether rivaroxaban combined with hypothermia or acidosis exhibit synergistic inhibitory effects on haemostasis using ROTEM^®.

Methods: Patients with a clinical indication to start rivaroxaban treatment were prospectively included. Blood samples were collected before initiation of treatment and the day after. All blood samples were in vitro modified with respect to temperature (incubated and analysed at 28, 33, 37 and 40 degrees Celsius (°C)) and pH (6.8, 7.0, 7.2 and 7.4). The temperature and acidosis effects on the ROTEM EXTEM variables clotting time (CT), clot formation time (CFT) and alpha-angle (AA) were measured along with the individual effect of rivaroxaban on the same variables. The additive effect was calculated. The observed (potential synergistic) effects for the temperature and pH modified rivaroxaban samples on the same ROTEM variables, were registered. Differences between the additive and observed (potential synergistic) effects were analysed using matched non-parametric hypothesis testing.

Results: In total, 13 patients were included. Hypothermia and rivaroxaban exhibited a synergistic effect on CT at 28 °C (p = 0.0002) and at 33 °C (p = 0.0007). The same applied for acidosis at pH 6.8 (p = 0.003) and pH 7.0 (p = 0.003). There were no signs of synergistic effects of rivaroxaban and temperature or acidosis on CFT. In AA there were signs of synergism at 28 °C (p = 0,001), but not at other tested temperatures or pH levels.

Conclusions: The combination rivaroxaban together with hypothermia or acidosis demonstrated inhibitory synergistic effects on haemostasis.

Trial registration: The study was retrospectively registered 2023-03-01 at ClinTrials.gov with NCT05669313.

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利伐沙班和低体温或酸中毒对使用 ROTEM® 测量的凝血启动的协同效应：一项前瞻性观察研究。

背景：低体温和酸中毒可单独抑制止血。我们设计了这项研究，旨在利用 ROTEM® 研究利伐沙班与低体温或酸中毒结合是否会对止血产生协同抑制作用：方法：前瞻性纳入具有利伐沙班治疗临床指征的患者。在开始治疗前和治疗后的第二天采集血液样本。所有血液样本都在体外进行了温度（在 28、33、37 和 40 摄氏度下培养和分析）和 pH 值（6.8、7.0、7.2 和 7.4）的调整。测量了温度和酸中毒对 ROTEM EXTEM 变量凝血时间（CT）、血块形成时间（CFT）和α-角（AA）的影响，以及利伐沙班对相同变量的单独影响。计算出了叠加效应。记录了温度和 pH 值改良的利伐沙班样品对相同 ROTEM 变量的观察效应（潜在协同效应）。使用匹配非参数假设检验分析相加效应和观察效应（潜在协同效应）之间的差异：共纳入 13 名患者。低温和利伐沙班在 28 °C（p = 0.0002）和 33 °C（p = 0.0007）时对 CT 有协同作用。在 pH 值为 6.8（p = 0.003）和 pH 值为 7.0（p = 0.003）时，酸中毒的情况也是如此。利伐沙班和温度或酸中毒对 CFT 没有协同作用。AA在28 °C时有协同作用的迹象（p = 0.001），但在其他测试温度或pH水平下没有协同作用：结论：利伐沙班联合低体温或酸中毒对止血具有抑制性协同作用：该研究于 2023-03-01 在 ClinTrials.gov 进行了回顾性注册，注册号为 NCT05669313。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Thrombosis Journal Medicine-Hematology

CiteScore

3.80

自引率

3.20%

发文量

审稿时长

16 weeks

期刊介绍： Thrombosis Journal is an open-access journal that publishes original articles on aspects of clinical and basic research, new methodology, case reports and reviews in the areas of thrombosis. Topics of particular interest include the diagnosis of arterial and venous thrombosis, new antithrombotic treatments, new developments in the understanding, diagnosis and treatments of atherosclerotic vessel disease, relations between haemostasis and vascular disease, hypertension, diabetes, immunology and obesity.