跳至主要内容
临床试验/NCT05995093
NCT05995093招募中不适用

The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

Qilu Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 462 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
462
试验地点
1
主要终点
whether DIC occured

研究概览

简要总结

The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.

详细描述

Disseminated intravascular coagulation (DIC) is a life-threatening condition with high mortality, necessitating timely and accurate diagnosis for effective management. However, current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing for proactive diagnosis before the disease progresses into its irreversible phase.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 94 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old, non-perinatal period, a hospitalization length of≥3 days.

排除标准

  • primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.

结局指标

主要结局

whether DIC occured

时间窗: From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.

DIC includes pre-DIC and overt-DIC

次要结局

  • whether death occurred(From date of admission until the date of death, assessed up to 5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miao Xu, MD

Principal Investigator

Qilu Hospital of Shandong University

研究点 (1)

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