Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-02 @ 7:58 AM
Study NCT ID:
NCT03242135
Status:
UNKNOWN
Last Update Posted:
2017-08-08
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-07', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Role of RDW (red cell distribution width) as a non invasive index for predicting liver cell failure and portal hypertension in cirrhotic patient', 'timeFrame': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Predicting Liver Cell Failure & Portal Hypertension in LC']}, 'descriptionModule': {'briefSummary': 'role of RDW as anon invasive method for predicting liver cell failure \\& portal hypertension in cirrhotic patient', 'detailedDescription': "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 ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '17 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nThe 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)\n\nExclusion Criteria:\n\n* Evidence of iron deficiency anaemia\n* Patients within one month of hematemesis\n* Thalassaemia"}, 'identificationModule': {'nctId': 'NCT03242135', 'acronym': 'RDW', 'briefTitle': 'Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Red Cell Distribution Width as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient', 'orgStudyIdInfo': {'id': '17100264'}}, 'contactsLocationsModule': {'locations': [{'zip': '088', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Marina principle investigator', 'role': 'CONTACT', 'email': 'marina_atef_62@yahoo.com', 'phone': '2650351'}, {'name': 'AssiutU faculty of medicine, master', 'role': 'CONTACT', 'email': 'vdeanpost@med.au.edu.eg', 'phone': '0882080177'}], 'facility': 'Marina Atef', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Marina Atef', 'role': 'CONTACT', 'email': 'marina_atef_62@yahoo.com', 'phone': '01012767870'}, {'name': 'AssiutU faculty of medicine, master', 'role': 'CONTACT', 'email': 'vdeanpost@med.au.edu.eg', 'phone': '0882080177'}], 'overallOfficials': [{'name': 'marina Atef, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marina Atef', 'investigatorAffiliation': 'Assiut University'}}}}