<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03242135</url>
  </required_header>
  <id_info>
    <org_study_id>17100264</org_study_id>
    <nct_id>NCT03242135</nct_id>
  </id_info>
  <brief_title>Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient</brief_title>
  <acronym>RDW</acronym>
  <official_title>Role of Red Cell Distribution Width as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      role of RDW as anon invasive method for predicting liver cell failure &amp; portal hypertension&#xD;
      in cirrhotic patient&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Red blood cell distribution width (RDW) is a measure of the range of variation of red blood&#xD;
      cell (RBC) volume. The RDW-SD (Standard deviation ) is an actual measure of size. Normal&#xD;
      reference range of RDW-SD in adult human is 39-46 fL .Liver plays an important role in&#xD;
      removing body toxins which affects RBCs ,so liver cirrhosis may affects the RDW. Cirrhosis is&#xD;
      a chronic degenerative disease in which irreversible scarring of the liver occurs. It leads&#xD;
      to liver failure. Child's score is used as an indicator for liver cell function Portal&#xD;
      hypertension is an increase in the blood pressure within the portal venous system&#xD;
      .Obstruction to blood flow that occurs in liver due to fibrosis and regenerating nodules&#xD;
      reduce flow from the portal veins into the hepatic veins. It also impedes hepatic artery flow&#xD;
      from the branches that feed into the sinusoids. This increase in arterial resistance leads to&#xD;
      an increase in arterial flow into the portal vein via producing a new anastamosis. The net&#xD;
      result of that is an increase in portal vein pressure and dilatation of portal vein. Direct&#xD;
      measurement of portal pressure is invasive, inconvenient, and clinically impractical. The&#xD;
      Hepatic Venous Pressure Gradient (HVPG) is used to measure portal pressure .Recently, portal&#xD;
      vein diameter is used as indicator for portal hypertension .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 21, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 21, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Role of RDW (red cell distribution width) as a non invasive index for predicting liver cell failure and portal hypertension in cirrhotic patient</measure>
    <time_frame>3 years</time_frame>
    <description>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 ) &amp; abdominal US</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Predicting Liver Cell Failure &amp; Portal Hypertension in LC</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include a total of 100 patient in Assiut university hospital diagnosed to be&#xD;
        cirrhotic by abdominal US&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The study will include a total of 100 patient in Assiut university hospital diagnosed to be&#xD;
        cirrhotic by abdominal US. They will be divided into 3 groups according to Child's score&#xD;
        (A,B,C)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of iron deficiency anaemia&#xD;
&#xD;
          -  Patients within one month of hematemesis&#xD;
&#xD;
          -  Thalassaemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>marina Atef, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marina Atef</last_name>
    <phone>01012767870</phone>
    <email>marina_atef_62@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>AssiutU faculty of medicine, master</last_name>
    <phone>0882080177</phone>
    <email>vdeanpost@med.au.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Marina Atef</name>
      <address>
        <city>Assiut</city>
        <zip>088</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina principle investigator</last_name>
      <phone>2650351</phone>
      <email>marina_atef_62@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>AssiutU faculty of medicine, master</last_name>
      <phone>0882080177</phone>
      <email>vdeanpost@med.au.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Marina Atef</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Portal</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03242135
org study id: 17100264
nct id: NCT03242135
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
role of RDW as anon invasive method for predicting liver cell failure & portal hypertension
      in cirrhotic patient
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 .
observational model: Cohort
time perspective: Prospective
measure: Role of RDW (red cell distribution width) as a non invasive index for predicting liver cell failure and portal hypertension in cirrhotic patient
time frame: 3 years
description: 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
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: 90 Years
healthy volunteers: No
last name: marina Atef, master
role: Principal Investigator
affiliation: Assiut University
last name: Marina Atef
phone: 01012767870
email: marina_atef_62@yahoo.com
last name: AssiutU faculty of medicine, master
phone: 0882080177
email: vdeanpost@med.au.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Marina Atef
investigator title: Principal Investigator
mesh term: Hypertension, Portal
mesh term: Hypertension