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临床试验/NCT03589430
NCT03589430Unknown不适用

Haemostatic Imbalance in Patients With Chronic Liver Disease- Its Relation to Severity and Outcome

Assiut University0 个研究点目标入组 100 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Assesment of haemostatic profile in different stages of liver cirrhosis

研究概览

简要总结

To assess the level of protein C, S ,antithrombin in patients with liver cirrhosis To correlate the level of these parameters with the degree of liver cirrhosis To correlate the level of procoagulants with the level of anticoagulant proteins in liver cirrhosis

详细描述

The liver has a cardinal role in the haemostatic system. Liver has the major role in synthesizing all clotting factors and coagulation inhibitors. Under the physiological conditions the balanced levels of procoagulant and anticoagulants determine the risk of hemorrhage and thrombosis.

In chronic liver disease due to chronic hepatitis and underlying cirrhosis, this haemostatic imbalance leads to hypercoagulability which favors thrombosis despite the longer coagulation times of their plasma, compared with that of healthy individuals. The end stage cirrhosis is however predominately associated with bleeding tendency.

Protein C (PC) and protein S (PS) are vitamin K-dependent glycoproteins, that act as natural anticoagulants.

Antithrombin III (AT III) is a natural anticoagulant that is synthesized exclusively in parenchymal cells of the liver The cause of hypercoagulability in chronic liver disease is the reduced level of protein C and increased level of factor VIIIa .As a consequence of hypercoagulability, the deep vein thrombosis, pulmonary embolism, hepatic and portal vein thrombosis may occur.

Varnika et al 2017 found a significantly low protein C value in both chronic hepatitis and cirrhosis group when compared with control group.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed as liver cirrhosis confirmed clinical , biochemical and ultrasonography.
  • severity of cirrhosis was assessed according to Child-Pugh score and MELD score.

排除标准

  • history of bleeding or thrombotic disorder,
  • history of renal disease, diabetes mellitus,
  • ongoing or recent pregnancy,
  • recent history of transfusion of blood products,
  • current anticoagulation therapy.
  • Hepatocellular carcinoma

结局指标

主要结局

Assesment of haemostatic profile in different stages of liver cirrhosis

时间窗: baseline

assessment of the level of protein C, S ,antithrombin in patients with liver cirrhosis, and correlate the level of these parameters with the degree of liver cirrhosis

次要结局

  • The value of anticoagulant use in patients with liver cirrhosis(baseline)

研究者

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

Sara Mohammed Mahrous Sayed

principal investigator

Assiut University

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