Haemostatic Imbalance in Patients With Chronic Liver Disease

July 16, 2018 updated by: Sara Mohammed Mahrous Sayed, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Acquired deficiency of АТ III can be caused by decreased synthesis due to damage to hepatic cells Patients with CLD were (and are still) subjected to laboratory screening with the prothrombin and activated partial thromboplastin times (PT and APTT), and those with abnormal values were (are) treated with plasma or procoagulant agents to correct the abnormalities and to prevent haemorrhage during invasive procedures or to stop bleeding from the gastrointestinal tract. Saja et al., and Saray et al 2009 found significantly low protein C value in both chronic hepatitis and cirrhosis group when compared with control group. This was a sign of reduced hepatocyte synthetic capacity in chronic hepatitis. Zocco et al 2009 showed that in CLD reduction in plasma levels of PC correlate with a higher Model For End-Stage Liver Disease (MELD) score. These findings, including the present one, confirm that levels of PC are sensitive markers .

Determination of the levels of AT III and aminotransferase activity in patients with liver disease may be used for differential diagnoses and the monitoring of disease progression.

Little attention had been paid to the fact that, similar to procoagulant factors, their anticoagulant counterparts (namely protein C [PC] and antithrombin) are also reduced to the same extent in this setting.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with liver cirrhosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 child A
child A liver cirrhosis
Other: Laboratory investigations ( protein C, protein S , antithrombin III)
laboratory investigations ( protein C , protein S , antithrombin)
2 child B
child B liver cirrhosis
Other: Laboratory investigations ( protein C, protein S , antithrombin III)
laboratory investigations ( protein C , protein S , antithrombin)
3 child C
child C liver cirrhosis
Other: Laboratory investigations ( protein C, protein S , antithrombin III)
laboratory investigations ( protein C , protein S , antithrombin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assesment of haemostatic profile in different stages of liver cirrhosis
Time Frame: 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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The value of anticoagulant use in patients with liver cirrhosis
Time Frame: baseline
Cirrhotic patients has bleeding disorders and also high possibility of developing thrmobosis , so secondary to this study which assess the cause of hypercoaguability state in liver cirrhosis, new studies can be based on this study to assess the value of use of anticoagulant therapy in cirrhotic patients who are at high risk of developing thrombosis
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

March 30, 2020

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Haemostasis imbalance in CLD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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