Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic

• Conditions: Venous Thromboembolism; Liver Cirrhosis
• Interventions: Device: thromboelastography

• Registration Number: NCT03580577
• Lead Sponsor: Assiut University

Brief Summary

patient with liver cirrhosis was supposed to have autoanticoagulation which approved to be wrong, with absence of conventional method to detect all abnormalities in coagulation state. Thromboelastography (TEG) give a broad picture for the coagulation defects.

In addition to that no guidelines prescribed anticoagulants for venous thromboembolism in cirrhotic, so the investigators will do a study to demonstrate frequency and risk factors for acute venous thromboembolism in cirrhotic patients, find a conventional laboratory method and test TEG to assess risk of thrombosis in cirrhotic patients.Also, to validate current algorithm for use of anticoagulant and antiplatelet for thromboembolism for non cirrhotic in cirrhotic patients.

Detailed Description

Nowadays, the term "autoanticoagulated" ,which prescribed coagulopathy state in chronic liver disease (CLD) patients due to impaired synthesis of coagulation factors and elevated international normalized ratio(INR), has been approved to be wrong and those patients are liable for venous thromboembolism (VTE) with 0.5% - 6.3% incidence of deep venous thrombosis (DVT) and pulmonary thromboembolism (PE) among cirrhotic patients.

This may be explained by normal or even increased production of factor VIII and von Willebrand factor, enhanced thrombin activity and Low level of protein C, protein S and antithrombin III due to impaired liver synthesis, other risk factor include sedentary lifestyle, fractures, immobility, hospitalization, elevated estrogen levels, surgery, concomitant disease states and cancer, damaged vasculature that increases inflammation, and sluggish splanchnic blood flow, which are all common in those patients.

Absence of gold standard estimation for hypercoagulability in cirrhotic patients, is a big problem. During measurement of conventional parameters such as international normalized ratio (INR) or partial thromboplastin time, reagents used to measure the prothrombin time do not contain thrombomodulin on which protein C depend for activation, so it does not adequately reflect reduced levels protein C. Thromboelastography a device that has the ability to measure whole blood coagulation cascade including platelet function, It can be used to monitor coagulation status before liver transplantation operation to properly identify and treat coagulation abnormalities.

No worldwide guidelines is established neither for management nor prophylaxis of VTE in cirrhotic patients, this may be due to safety concerns regarding the risk of bleeding related to anticoagulant drugs when used in people with advanced liver disease, especially if there is significant thrombocytopenia, and/or the presence of varices.

Study Timeline

• Study First Submitted: 2018-06-16
• Study First Submitted QC: 2018-06-26
• Status Verified: 2018-07
• Study First Posted: 2018-07-09
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30
• Study Start: 2018-09-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• all cirrhotic patient who developed venous thromboembolic events
• written informed consent (patient or nearest relative )

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Exclusion Criteria

• Patient with chronic thromboembolic event ( e.g. chronic pulmonary embolism, chronic portal vein thrombosis).
• patients on antiplatelets or anticoagulants.
• Patients with end stage kidney, heart or lung diseases
• Pregnant.
• Cirrhotic patients on control group who develop an acute thromboembolic event during the study period will be excluded and shifted to the case group

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhotic with venous thromboembolism	thromboelastography	cirrhotic patients with a venous thromboembolic event (including deep venous thrombosis, pulmonary embolism, acute non-malignant portal vein thrombosis, splenic vein, inferior vena cava thrombosis or mesenteric vascular occlusion). Each patient will subjected to through history taking and careful examination to detect and risk factors also laboratory work to detect thrombocytopenia, disease severity, coagulation status thrombelastography before starting anticoagulants. * Patients will start treatment with anticoagulants therapy after liaise with the specialized physician. * Protein C, protein S and antithrombin III level will be assessed 3 months after the acute thrombotic event and 1 month of vitamin K antagonist (VKA) withdrawal.

Primary Outcome Measures

Name	Time	Method
Occurence of recanalization of thrombosed vessel	24 weeks from baseline	Efficacy of anticoagulants describe its ability to prevent further thrombosis and restore patency of thrmobosed vessel

Secondary Outcome Measures

Name	Time	Method
detect safety of anticoagulants in cirrhotic	During treatment period wither 12 or 24 weeks from starting therapy	Occurrence of any bleeding event while on anticoagulants therapy
Correlate thromboelastography results with hypercoagluable state in cirrhotic patients with venous thromboembolism	1 day	Changes in r, k and MA- TEG parameters in cirrhotic patients with venous thromboembolism

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt