Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Changes in endogenous thrombin potential as assessed by thrombin generation test
研究概览
简要总结
Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of inflammation, which could lead either to hypercoagulability or hypocoagulability. It is currently not possible to determine the hemostatic status of a given patient. This instability of hemostatic system is not revealed by classical tests. Thus, a better characterization of hemostatic status could certainly improve patient care. This study aims at characterizing disorders of coagulation and fibrinolysis using "global" tests such as thrombin generation test or coagulolytic test. Furthermore, the association with biological markers of interest (such as microparticles, neutrophil elastase or histones) will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria for patients with septic schock
- •Inclusion Criteria:
- •septic shock (Dellinger, 2013)
- •age >18y
- •hospitalized patients
- •signature of an informed consent (emergency consent)
- •affiliation to a social security regimen
排除标准
- •pregnancy or breast-feeding women
- •moribund patient
- •oral anticoagulant therapy
- •thrombophilia
- •Minor patients
- •Patients under tutelage
- •Eligibility criteria from subject without septic shock Subject blood samples without septic shock are collected from a historical healthy volunteers cohort.
结局指标
主要结局
Changes in endogenous thrombin potential as assessed by thrombin generation test
时间窗: 48 hours
thrombin generation will be measured using CAT method (fluorescence) in plasma from patients within 48 hours. Endogenous thrombin potential is defined as the area under the thrombin generation curve and will be compared with values obtained in healthy subjects
次要结局
- Correlation of neutrophil elastase with changes in endogenous thrombin potential(48 hours)
- Correlation of cell-derived microparticles with changes in endogenous thrombin potential(48 hours)
- Changes in Thrombin peak as assessed by thrombin generation test(48 hours)
- Changes in clot lysis time as assessed by clot lysis assay(48 hours)
- Correlation of circulating histones with changes in endogenous thrombin potential(48 hours)
研究者
Pr Bruno LEVY
Professor
Central Hospital, Nancy, France