An Observational Study on the Prognostic Function of Early Coagulopathy in Sepsis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- 28-day all course mortality
研究概览
简要总结
In this cohort study, the parameters (TM, TAT, PIC, tPAIC, et al.) associated with the hemostatic system will be collected in sepsis patients when admitted to the Intensive Critical Unit. Parameters will be evaluated for their prognostic function of 28 days mortality.
详细描述
The object of this study is to find the early mortality prognostic biomarkers within the hemostatic system in sepsis patients. Blood samples will be collected from sepsis patients at admission. Parameters reflect endothelial injury, such as thrombomodulin (TM), tissue type plasminogen activator inhibitor complex (tPAIC), parameters reflect procoagulation condition, such as thrombin-antithrombin complex (TAT), and parameters reflect hyperfibrinolysis, such as plasmin-plasmin inhibitor complex (PIC) will be tested. Based on the results of these parameters, sepsis patients will be divided into coagulation parameter normal or abnormal groups. Twenty-eight days of mortality will be determined by patient follow-up. Regression analysis will be used to evaluate the relationship between these parameters and the mortality of sepsis patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from August 2020 to July
- •Patients diagnosed with sepsis. The criteria for diagnosis is:
- •Infection or suspected infection;
- •SOFA score ≥
- •Age interval: 18 years -- 80 years.
- •Gender: unlimited.
- •Signed informed consent form received.
- •Results of the coagulation parameters tested within 24 hours after admission are available.
排除标准
- •Pregnant and lactating women.
- •With primary diseases that can cause thrombocytopenia or prolong prothrombin time, such as leukemia.
- •Patients with severe liver dysfunction.
- •Patients with anticoagulation or fibrinolysis medications within 72 hours before admission.
- •Patients are in a procoagulation condition, such as VTE patients, protein C or protein S deficient individuals.
- •Patients with chronic renal failure.
- •Patients need ECMO therapy.
- •Patients with severe cardiopulmonary diseases or nervous system diseases.
- •Patients at the end-stage of disease.
- •Patients without signed informed consent forms.
结局指标
主要结局
28-day all course mortality
时间窗: 28 days from ICU-admission
次要结局
- Length of stay(28 days from ICU-admission)
- Length of using vasopressor(28 days from ICU-admission)
研究者
Hua-Qing Shu
Associated Professor
Wuhan Union Hospital, China