Predisposing Factors for Liver Diseases in Patients With Chronic Hemolytic Anemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to detect risk factors for liver affection in patients with chronic hemolytic anemias presented to the hematology unit.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemolytic Anemia, Chronic Liver Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Saadiea Abdo Bedir Eid

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohammed Abbas Al masry, Pro

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Saadiea Abdo Badir, Resident

Role: CONTACT

Phone: 01010879993

Email: [email protected]

Maha Mohammed Abd El Aziz, Dr