Role of Thromboelastography in Septic Shock: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- risk of bleeding
研究概览
简要总结
Coagulation dysfunction is frequent in septic patients and it is associated with an increase risk of mortality. During sepsis platelets number usually decreases and their function is reduced and this mechanism is sustained by an inflammatory induced coagulopathy. Some recent studies evaluated the possibility to use viscoelastic whole blood tests of the haemostasis, such as thromboelastography (TEG), which analyze all blood components and their interactions during clot formation and dissolution and might be useful for assessing bleeding risk in septic patients. Maximun amplitude (MA) is one of the variables obtained from TEG analysis and it expresses the strength of the clot and the efficacy of platelet function. A low level of MA describes a lower strength of the clot determined by a lower number or a reduced function of platelet.
The aim of the present study is to evaluate whether a lower level of MA and a pattern of hypocoagulability might be associated with an increased risk of bleeding and need of transfusion in patients with sepsis.
We want to conduct a prospective multicenter observational study, enrolling 100 consecutive adults patients with sepsis. We will exclude patients under 18 years old of age, chronic use of oral anticoagulant and anti platelet treatment, hematologic malignancy, congenital bleeding disorders, oral contraceptives, lack of consent.
Primary end point To evaluate whether a lower level of MA might be associated with an increased risk of bleeding.
Secondary end points: to evaluate whether a different level of MA correlates with the biomarker of the severity of sepsis such as presepsin, with the biomarker of the severity of infection and whether a pattern of hypocoagulability might be associated with a risk of mortality.
All enrolled patients will undergo a blood sample at admission (T0), after 72 hours (T1) and after 7 days (T2) and all the following parameters will be measured:
Platelet count, APTT, PT, INR, fibrinogen, procalcitonin and presepsin .
Additionally, all viscoelastic parameters (reaction time (R), clot formation speed (K), angle (alpha) and maximum amplitude (MA)) will be performed at bedside, at T0, T1, T2:
Outcome measurements: Intensive Care Unit Length of Stay and mortality at 28 days and at 90 days.
详细描述
Introduction
Coagulation dysfunction is frequent in patients with severe sepsis and it is associated with an increase risk of mortality. During sepsis platelets number usually decreases and their function is reduced and this mechanism is sustained by an inflammatory induced coagulopathy. Several studies have showed a correlation between altered function of platelets and sepsis severity.
Conventional coagulation tests such as activated partial thromboplastin time (APTT), prothrombin time (PT) and international normalized ratio (INR) were developed mainly to monitor anticoagulation treatment and may not fully reflect the complex in vivo coagulation disturbances that usually characterizes sepsis. More recently some studies evaluated the possibility to use viscoelastic whole blood tests of the haemostasis, such as thromboelastography (TEG) and thromboelastometry (ROTEM), which analyze all blood components and their interactions during clot formation and dissolution and might be useful for assessing bleeding risk in septic patients.
A more recent study identified a possible hypocoagulability pattern among septic patients at risk of bleeding using TEG variable and the authors found a strong correlation with increased risk of death. Maximun amplitude (MA) is one of the variables obtained from TEG analysis and it expresses the strength of the clot and the efficacy of platelet function. A low level of MA describes a lower strength of the clot determined by a lower number or a reduced function of platelet. In one recent study it has been described that a lower MA describing a hypocoagulability pattern might be associated with an increased risk of death.
The aim of the present study is to evaluate whether a lower level of MA and a pattern of hypocoagulability might be associated with an increased risk of bleeding and need of transfusion in patients with sepsis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •all adult patients with diagnosis of sepsis admitted for more than 48 hours will be enrolled
排除标准
- •patients younger than 18 years old of age; chronic use of oral anticoagulant and anti platelet treatment; hematologic malignancy; congenital bleeding disorders; oral contraceptives; lack of consent
结局指标
主要结局
risk of bleeding
时间窗: 7 days
To evaluate whether a lower level of MA might be associated with an increased risk of bleeding
次要结局
- mortality(28 days and 90 days)
- Intensive Care Unit Length of Stay(28 days)
研究者
Daniela Pasero
Medical Doctor
University of Turin, Italy