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脓毒症诱导凝血病(INSIC)发生率试验:一项回顾性与前瞻性相结合、多中心、国际性、横断面、纵向及流行病学观察性试验的研究方案

Incidence of Sepsis-Induced Coagulopathy (INSIC) Trial: Study Protocol of a Combined Retrospective and Prospective, Multicenter, International, Cross-Sectional, Longitudinal, and Epidemiological Observational Trial.

作者信息

Schmoch Thomas, Möhnle Patrick, Weigand Markus A, Dietrich Maximilian, Gregorius Jonas, Frank Sandra, Briegel Josef, Radke David I, Bauer Michael, Bloos Frank, Meybohm Patrick, Bogatsch Holger, Brenner Thorsten

机构信息

Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, 45141 Essen, Germany.

Department of Anesthesiology and Intensive Care Medicine, Hôpitaux Robert Schuman-Hôpital Kirchberg, L-2540 Luxembourg City, Luxembourg.

出版信息

J Clin Med. 2025 Jun 13;14(12):4222. doi: 10.3390/jcm14124222.

Abstract

Sepsis and septic shock are the most severe forms of infection. Due to the intensive cross-talk of the coagulation and immune system, coagulopathies regularly occur in sepsis. The International Society on Thrombosis and Hemostasis refers to these coagulation abnormalities as sepsis-induced coagulopathies (SICs). The presence of SICs can be assessed using the SIC score. In parallel, a score for "sepsis-associated coagulopathy" (SAC) was introduced that, in contrast to the SIC score, allows coagulopathy to be classified according to its severity. In the past, multicenter, randomized controlled trials have repeatedly failed to prove the efficacy of specific therapeutic measures targeting SICs or SACs. This could potentially be explained by insufficient knowledge about the prevalence and incidence of SIC and the rate of spontaneous recovery. The Incidence of Sepsis-Induced Coagulopathy (INSIC) trial is intended to address this problem. The aim of the INSIC trial is to measure the incidence and prevalence of SIC-in addition to the rate of spontaneous SIC recoveries-during the first days of sepsis treatment to provide a solid base of data for future interventional trials. We aim to include all patients with sepsis treated in any one of 150 participating intensive care units in 100 hospitals located in Austria, Luxembourg, and Germany to determine the prevalence of SIC (on day 1 of the study period as well as on three selected days in the fourth quarter of each year from 2019 to 2024). SIC incidence will be assessed over a 14-day period starting on 10 March 2025. Secondary endpoints are 28-day survival and the occurrence of severe thromboembolic events and bleeding. In addition, each of the aforementioned outcome parameters will be assessed for correlation with the severity classification of the SAC score. The INSIC trial is the first study to determine the prevalence as well as the incidence of SIC, to prospectively examine the course of SIC longitudinally over a 14-day period, and to determine the rate of spontaneous recoveries within 72 h under standard treatment in a large cohort of patients. This information will provide a sound basis for future studies.

摘要

脓毒症和脓毒性休克是最严重的感染形式。由于凝血系统和免疫系统之间存在强烈的相互作用,脓毒症患者经常出现凝血病。国际血栓与止血协会将这些凝血异常称为脓毒症诱导的凝血病(SICs)。SICs的存在可以通过SIC评分来评估。与此同时,还引入了一个“脓毒症相关凝血病”(SAC)评分,与SIC评分不同的是,该评分可以根据凝血病的严重程度进行分类。过去,多中心随机对照试验多次未能证明针对SICs或SACs的特定治疗措施的有效性。这可能是由于对SIC的患病率、发病率以及自发恢复率了解不足所致。脓毒症诱导凝血病发病率(INSIC)试验旨在解决这一问题。INSIC试验的目的是在脓毒症治疗的最初几天测量SIC的发病率和患病率,以及SIC的自发恢复率,为未来的干预试验提供坚实的数据基础。我们的目标是纳入在奥地利、卢森堡和德国100家医院的150个参与研究的重症监护病房中接受治疗的所有脓毒症患者,以确定SIC的患病率(在研究期第1天以及2019年至2024年每年第四季度的三个选定日期)。SIC发病率将从2025年3月10日开始的14天内进行评估。次要终点是28天生存率、严重血栓栓塞事件和出血的发生情况。此外,还将评估上述每个结局参数与SAC评分严重程度分类的相关性。INSIC试验是第一项确定SIC患病率和发病率、在14天内纵向前瞻性研究SIC病程、并在一大群患者的标准治疗下确定72小时内自发恢复率的研究。这些信息将为未来的研究提供坚实的基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/645d/12194450/eff933baec2d/jcm-14-04222-g001.jpg

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