Predicting Liver Cell Failure & Portal Hypertension in LCRDWNCT03242135
Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient
An observational study of Predicting Liver Cell Failure & Portal Hypertension in LC, run by Assiut University at 1 site in Egypt.
Trial summary
role of RDW as anon invasive method for predicting liver cell failure \& portal hypertension in cirrhotic patient Read more about this study
- Who is it for?
- Ages 17 to 90 years
- Conditions the study is for
- Predicting Liver Cell Failure & Portal Hypertension in LC
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2016to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US
Who may be able to join
- 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)
Who cannot join
- Evidence of iron deficiency anaemia
- Patients within one month of hematemesis
- Thalassaemia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Marina Atef
Asyut, 088
Marina principle investigator, 2650351, marina_atef_62@yahoo.com
AssiutU faculty of medicine, master, 0882080177, vdeanpost@med.au.edu.eg
About this study
Official title: 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
Read the 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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start21 Sep 2016
- Primary completion21 Feb 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predicting Liver Cell Failure & Portal Hypertension in LCStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Atef, Assiut University
- Investigators
- marina Atef, master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242135
- Sponsor's protocol ID
- 17100264
- Acronym
- RDW
- Status last verified
- Aug 2017
- First submitted
- 4 Aug 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Red Cell Distribution Width as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient
- ClinicalTrials.gov ID
- NCT03242135
- Acronym / sponsor ID
- RDW / 17100264
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 21 Feb 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
role of RDW as anon invasive method for predicting liver cell failure \& portal hypertension in cirrhotic patient
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- Evidence of iron deficiency anaemia
- Patients within one month of hematemesis
- Thalassaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marina Atef, master principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Predicting Liver Cell Failure & Portal Hypertension in LC, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Atef (01012767870, marina_atef_62@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.