Oxidative Stress and Haemostasis Abnormalities in Cirrhosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Oxidative stress markers
研究概览
简要总结
Patients with cirrhosis can have abnormalities in laboratory tests reflecting changes in primary and secondary haemostasis.
Such changes have been considered particularly relevant in the bleeding complications that occur in cirrhosis.
However, several studies have shown that routine diagnostic tests are not clinically useful to stratify bleeding risk in patients with cirrhosis. Moreover, treatments used to increase platelet count or to modulate platelet function could potentially do harm. Consequently the optimal management of bleeding complications is still a matter of discussion.
Moreover, in the last two decades there has been an increased recognition that not only bleeding but also thrombosis complicates the clinical course of cirrhosis. Over the last years, emerge that in vivo platelet function and coagulation cascade might be modulated by an alteration of pro-oxidant and antioxidant balance. Thus It has previously been demonstrated that chronic liver diseases are characterized by increased oxidative stress state.
Aim of the study is to analyse the relationship between oxidative stress, haemostatic balance and clinical complications in cirrhosis.
详细描述
Natural history of cirrhotic patients is complicated by gastrointestinal bleeding which remains the most dramatic event considering is acute onset and is negative impact on life expectancy of LC patient. Over the last decade, improvements in therapy produce a sensible reduction in mortality of at least 20% at 6 weeks (8% at 24 hours) for each one episode of gastrointestinal bleeding.
Furthermore, portal vein thrombosis (PVT) is a frequent (10-20%) event in liver cirrhosis (LC), often asymptomatic, which may worsen its clinical course by favouring gastrointestinal bleeding, in particular precipitating the grade of portal hypertension.
Standing the coexistence of thrombotic and bleeding manifestations of difficult interpretation and management, only the elucidation of the mechanism leading to this complex hemostatic disturbance occurring in LC, would help us to explore new therapeutic strategies to prevent bleeding improving clinical outcomes.
However the mechanisms underlying specific cirrhotic hemostatic disturbance is still unclear.
On the last decade, has been investigated the presence of abnormalities in all hemostatic phases such as primary haemostasis (altered platelet function) or fibrinolysis and coagulation (impaired synthesis and activity of coagulation factors or hyperfibrinolysis.). The derangement of coagulation balance has been investigated and several studies identified abnormal haemostasis tests or coagulation factors as useful prognostic indexes of survival in LC patients Observational studies have shown that Factor VII, vitamin k dependent with short half-life (2 hours) is useful prognostic index of both acute and chronic liver insufficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis of any etiology and severity
- •Signed Written Informed Consent
排除标准
- •Treatment with non steroidal anti-inflammatory drugs or antithrombotic drugs (antiplatelets and anticoagulants)
- •Vitamin Supplementation
- •Pregnancy
- •Cholestatic liver disease
- •Hepatocarcinoma and Extrahepatic neoplasm
- •Active infective or inflammatory diseases
- •Recent major or minor surgery (< 3 months)
结局指标
主要结局
Oxidative stress markers
时间窗: 2 years
Evaluate the F2-Isoprostanes, in vivo oxidative stress markers, production in cirrhotic patients and its influence on haemostatic balance.
次要结局
- Thrombotic Events(2 years)
- Bleeding Events(2 years)
研究者
Francesco Violi
Director, Head of Internal Medicine, Principal Investigator, Clinical Professor
University of Roma La Sapienza