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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03242135
Other study ID # 17100264
Secondary ID
Status Recruiting
Phase N/A
First received August 4, 2017
Last updated August 7, 2017
Start date September 21, 2016
Est. completion date December 30, 2018

Study information

Verified date August 2017
Source Assiut University
Contact Marina Atef
Phone 01012767870
Email marina_atef_62@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 30, 2018
Est. primary completion date February 21, 2018
Accepts healthy volunteers No
Gender All
Age group 17 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Marina Atef Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Role of RDW (red cell distribution width) as a non invasive index for predicting liver cell failure and portal hypertension in cirrhotic patient 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 3 years