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Completed

NCT Number: NCT01774617

Comparative Analysis of Different Tests to Evaluate Prognosis of Patients on Liver Transplant Waiting List

It is a cohort to evaluate the power of different diagnostic tests in predicting the prognosis of patients with severe liver disease.

Patients with decompensated liver cirrhosis on the waiting list for liver transplantation will be evaluated with comparison of different diagnostic tests according to the MELD score (Model for End-Stage Liver Disease), MELD-Na (Model for End-Stage Liver Disease and sodium), indocyanine green clearance test, hepatic venous pressure gradient and transient elastography. All patients will be submitted to all the tests and prospectively followed for 6 months, to establish mortality and complications related to liver disease in order to define the value of each method to predict outcomes.

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Key information

Conditions

Cirrhosis Digestive System Diseases Fibrosis Hepatic Insufficiency Hypertension, Portal Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro

Rio de Janeiro, 21941-913, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the study includes patients (80 patients)
  • were male and female
  • aged between 18 and 69 years with chronic liver disease
  • with MELD inclusion greater than or equal to 14 to 30

Exclusion criteria

  • they have been transplanted
  • have a diagnosis of primary malignant liver (HCC) signed by imaging tests performed
  • MELD scores greater than 30.

Treatment and study plan

Primary outcomes

  1. All cause mortality

    Time frame: 6 months

    Mortality within 6 months after evaluation, classifying as related or non-related to liver disease

Secondary outcomes

  1. Chronic liver failure and portal hypertension complications

    Time frame: 6 months

    Complications:

    • gastroesophageal variceal bleeding
    • worsening of hepatic encephalopathy
    • decompensated ascites and spontaneous bacterial peritonitis
    • hepatorenal syndrome

Sponsors and collaborators

Lead sponsor

Guilherme Rezende

Other

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

Comparative Analysis of Indocyanine Green Clearance Test, MELD Score, MELD-Na Score, Transient Elastography and Hepatic Venous Pressure Gradient to Evaluate Prognosis of Patients on Liver Transplant Waiting List

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2013
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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