跳至主要内容
临床试验/NCT04356144
NCT04356144已完成不适用

Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2020年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
ETP (AUC) without rhThrombomodulin (rhTM)

研究概览

简要总结

Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Admission to ICU
  • Clinical signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2
  • Neutrophil-Lymphocyte Ratio (NLR) >3

排除标准

  • Intake of oral anticoagulants or any kind of parenteral therapeutic anticoagulation prior to ICU admission
  • Congenital coagulation disorder
  • Treatment with Prothrombin complex concentrate (F. II, VII, IX, X) or activated Prothrombin complex within past 48 hours
  • Treatment with recombinant factor VIIa (e.g. eptacog alfa) within past 48 hours
  • Treatment with recombinant protein C within past 48 hours
  • Active bleeding
  • Acute myocardial infarction
  • HIV infection
  • Chronic pancreatitis
  • Liver cirrhosis

结局指标

主要结局

ETP (AUC) without rhThrombomodulin (rhTM)

时间窗: 6 months

nM;

ETP (AUC) with rhThrombomodulin (rhTM)

时间窗: 6 months

nM;

ETP-ratio

时间窗: 6 months

Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM

ETP-Normalisation

时间窗: 6 months

Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors

次要结局

未报告次要终点

研究者

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

Lukas Infanger

Principal Investigator

Medical University of Vienna

研究点 (1)

Loading locations...

相似试验

Thrombomodulin-modified Thrombin Generation Assay... | 临床试验