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Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03242135
Collaborator
(none)
100
Enrollment
1
Location
27.3
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

role of RDW as anon invasive method for predicting liver cell failure & portal hypertension in cirrhotic patient

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Red blood cell distribution width (RDW) is a measure of the range of variation of red blood cell (RBC) volume. The RDW-SD (Standard deviation ) is an actual measure of size. Normal reference range of RDW-SD in adult human is 39-46 fL .Liver plays an important role in removing body toxins which affects RBCs ,so liver cirrhosis may affects the RDW. Cirrhosis is a chronic degenerative disease in which irreversible scarring of the liver occurs. It leads to liver failure. Child's score is used as an indicator for liver cell function Portal hypertension is an increase in the blood pressure within the portal venous system .Obstruction to blood flow that occurs in liver due to fibrosis and regenerating nodules reduce flow from the portal veins into the hepatic veins. It also impedes hepatic artery flow from the branches that feed into the sinusoids. This increase in arterial resistance leads to an increase in arterial flow into the portal vein via producing a new anastamosis. The net result of that is an increase in portal vein pressure and dilatation of portal vein. Direct measurement of portal pressure is invasive, inconvenient, and clinically impractical. The Hepatic Venous Pressure Gradient (HVPG) is used to measure portal pressure .Recently, portal vein diameter is used as indicator for portal hypertension .

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Role of Red Cell Distribution Width as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient
    Actual Study Start Date :
    Sep 21, 2016
    Anticipated Primary Completion Date :
    Feb 21, 2018
    Anticipated Study Completion Date :
    Dec 30, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Role of RDW (red cell distribution width) as a non invasive index for predicting liver cell failure and portal hypertension in cirrhotic patient [3 years]

      To develop a simple predictive method for liver cell failure and portal hypertension in cirrhotic patient using the routine hematological parameters (RDW in complete blood count ) & abdominal US

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US. They will be divided into 3 groups according to Child's score (A,B,C)

    Exclusion Criteria:

    • Evidence of iron deficiency anaemia

    • Patients within one month of hematemesis

    • Thalassaemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marina Atef Assiut Egypt 088

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: marina Atef, master, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marina Atef, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03242135
    Other Study ID Numbers:
    • 17100264
    First Posted:
    Aug 8, 2017
    Last Update Posted:
    Aug 8, 2017
    Last Verified:
    Aug 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension, Portal
    Hypertension

    Study Results

    No Results Posted as of Aug 8, 2017