- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03242135
Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient (RDW)
August 7, 2017 updated by: Marina Atef, Assiut University
Role of Red Cell Distribution Width as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient
role of RDW as anon invasive method for predicting liver cell failure & portal hypertension in cirrhotic patient
Study Overview
Status
Unknown
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Assiut, Egypt, 088
- Recruiting
- Marina Atef
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Contact:
- AssiutU faculty of medicine, master
- Phone Number: 0882080177
- Email: vdeanpost@med.au.edu.eg
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Contact:
- Marina principle investigator
- Phone Number: 2650351
- Email: marina_atef_62@yahoo.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: marina Atef, master, Assiut University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2016
Primary Completion (Anticipated)
February 21, 2018
Study Completion (Anticipated)
December 30, 2018
Study Registration Dates
First Submitted
August 4, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 8, 2017
Study Record Updates
Last Update Posted (Actual)
August 8, 2017
Last Update Submitted That Met QC Criteria
August 7, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17100264
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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