- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06743854
Predisposing Factors for Liver Diseases in Patients With Chronic Hemolytic Anemia
Study Overview
Status
Conditions
Detailed Description
Hemolytic anemia is defined as decreased levels of erythrocytes in circulating blood due to their premature destruction.It is classified to acute and chronic haemolytic anemia ,chronic hemolytic anemia includes thalassemia and sickle cell anemia.
A thalassemia is a group of hereditary disorders. Mutations causing this disease reduce the production of alpha-globin and beta (β) -globin chains ,Beta thalassemia is an autosomal recessive disorder that results from genetic deficiency in the synthesis of beta-globin chains. There are more than 200 known mutations in beta globin gene that cause thalassemia thus it has wide spectrum of severity. Clinically, beta thalassemia syndromes are classified into thalassemia trait, transfusion dependent thalassemia "TDT" or non-transfusion-dependent thalassemia " NTDT
TDT" patients are liable for several medical complications that can lead to death. Liver disease is the most important and common of them. Common risk factors for this are extramedullary hematopoiesis, hepatic iron overload, infection with hepatitis virus and chelation therapy toxicity.Thalassemia traditionally has a high prevalence in the Mediterranean area, countries in the Middle East, the Arabic peninsula and Southeast Asia.
Patient with Sickle cell disease (SCD) have experienced a great amelioration in quality of life, appreciations goes to the introduction of modern transfusions of filtered red cells . However, blood transfusions cause iron accumulation over the years, and in the absence of physiologic ability to excrete excess iron , there is a progressive damage of major organs; such as the heart, the liver, and endocrine system .
Iron accumulation can be measured by determining serum ferritin levels because it best reflects the body's iron status.Liver is a storage place for iron and the only site of transferrin and ferritin synthesis, and hence the first organ to be affected.chelation therapy is necessary to prevent iron accumulation and/or to remove excess iron.
Liver involvement in patients with chronic haemolytic anemia includes a wide range of alterations, from mild liver function test abnormalities to cirrhosis and acute liver failure.the pathogenesis of cirrhosis is related to chronic hepatitis B or C infection and iron overload as a result of hemolysis and multiple transfusions that these patients require in their lifetime.
Patients with B thalassemia are at increased risk of hepatocellular carcinoma (HCC).the risk of HCC development in beta-thalassemia is linked to several factors: the high risk of infections transmitted by blood transfusions, responsible of chronic liver diseases as hepatitis C virus (HCV) and, hepatitis B virus (HBV); the debatable risk that blood transfusions inhibit immune-surveillance against cancer .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Saadiea Abdo Badir, Resident
- Phone Number: 01010879993
- Email: saadieabedier@gmail.com
Study Contact Backup
- Name: Maha Mohammed Abd El Aziz, Dr
- Phone Number: 01097278659
- Email: maha.hemarology@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All patients presented to Clinical Hematology unit, Internal Medicine Department at Assuit university University with
- thalassemia .
- sickle cell anemia.
Exclusion Criteria:
patients with history of :
- alcohol consumption
- malignancy
- autoimmune hepatitis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To detect risk factors for liver affection in patients with chronic hemolytic anemias presented to the hematology unit.
Time Frame: 12/2024 - 12/2026
|
Liver involvement in patients with chronic haemolytic anemia includes a wide range of alterations, from mild liver function test abnormalities to cirrhosis and acute liver failure.the
pathogenesis of cirrhosis is related to chronic hepatitis B or C infection and iron overload as a result of hemolysis and multiple transfusions that these patients require in their lifetime Patients with B thalassmia are at increased risk of hepatocellular carcinoma (HCC).the
risk of HCC development in beta-thalassemia is linked to several factors: the high risk of infections transmitted by blood transfusions, responsible of chronic liver diseases as HCV and, HBV; the debatable risk that blood transfusions inhibit immune-surveillance against cancer
|
12/2024 - 12/2026
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohammed Abbas Al masry, Pro, Assiut University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chronic hemolytic anemia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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