Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03580577
Recruitment Status : Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Radwan Riad, 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.


Condition or disease Intervention/treatment
Liver Cirrhosis Venous Thromboembolism Device: thromboelastography

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic Patients: A Hospital Based Prospective Study
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cirrhotic with venous thromboembolism

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.
Device: thromboelastography
thromboelastography will assess all coagulation abnormalities including platelets function in cirrhotic group with venous thromboembolism , and guide us about is there increased thrombosis risk or not, for that a fresh blood sample will be withdrawn from each patient before starting any treatment

Cirrhotic without venous thromboembolism

cirrhotic patients without any thrombotic events Each patient will subjected to through history taking and careful examination to detect and risk factors.

- Protein C, protein S and antithrombin III level will be assessed at baseline.




Primary Outcome Measures :
  1. Occurence of recanalization of thrombosed vessel [ Time Frame: 24 weeks from baseline ]
    Efficacy of anticoagulants describe its ability to prevent further thrombosis and restore patency of thrmobosed vessel


Secondary Outcome Measures :
  1. detect safety of anticoagulants in cirrhotic [ Time Frame: During treatment period wither 12 or 24 weeks from starting therapy ]
    Occurrence of any bleeding event while on anticoagulants therapy

  2. Correlate thromboelastography results with hypercoagluable state in cirrhotic patients with venous thromboembolism [ Time Frame: 1 day ]
    Changes in r, k and MA- TEG parameters in cirrhotic patients with venous thromboembolism



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
liver cirrhosis patients with acute venous thromboembolism (VTE), control group of cirrhotic patients without VTE
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580577


Contacts
Layout table for location contacts
Contact: Ahmed Radwan Riad +2 01126435001 dr.radwan1988@gmail.com
Contact: Mohamed Abdel Sabour Mohamed Mekky mmekky75@yahoo.com

Locations
Layout table for location information
Egypt
Assiut university
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Director: Mohamed Abdel Sabour Mohamed Mekky Assiut University

Publications:

Layout table for additonal information
Responsible Party: Ahmed Radwan Riad, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03580577     History of Changes
Other Study ID Numbers: Liver cirrhosis and thrombosis
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Thromboembolism
Venous Thromboembolism
Liver Cirrhosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Antithrombin III
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants