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Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic

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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

Tracking Information
First Submitted Date June 16, 2018
First Posted Date July 9, 2018
Last Update Posted Date July 30, 2018
Estimated Study Start Date September 1, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 7, 2018)
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
Original Primary Outcome Measures
 (submitted: June 26, 2018)
  • detect risk factor for venous thrombosis in cirrhotic [ Time Frame: baseline ]
    Assess presence of risk factors for venous thromboembolism in cirrhotic patient
  • detect efficacy of anticoagulants in cirrhotic [ Time Frame: 24 weeks from baseline ]
    Efficacy of anticoagulants describe its ability to prevent further thrombosis and restore patency of thrmobosed vessel
Change History Complete list of historical versions of study NCT03580577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 26, 2018)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic
Official Title Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic Patients: A Hospital Based Prospective Study
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population liver cirrhosis patients with acute venous thromboembolism (VTE), control group of cirrhotic patients without VTE
Condition
  • Liver Cirrhosis
  • Venous Thromboembolism
Intervention 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
Study Groups/Cohorts
  • 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.
    Intervention: Device: thromboelastography
  • 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 26, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ahmed Radwan Riad +2 01126435001 dr.radwan1988@gmail.com
Contact: Mohamed Abdel Sabour Mohamed Mekky mmekky75@yahoo.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03580577
Other Study ID Numbers Liver cirrhosis and thrombosis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ahmed Radwan Riad, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Director: Mohamed Abdel Sabour Mohamed Mekky Assiut University
PRS Account Assiut University
Verification Date July 2018