An observational study in Hemolytic Anemia, Chronic and Liver Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Assiut University · Observational
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.
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 .
56 studies on the registry are indexed under Anemia, Hemolytic; 16 are open to participants now.
This study's planned enrollment of 58 is close to the median of 56 across 16 observational studies indexed under Anemia, Hemolytic.
Browse Anemia, Hemolytic studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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It is cross sectional descriptive study in which all patients with B thalassemia and sickle cell anemia will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients presented to Clinical Hematology unit, Internal Medicine Department at Assuit university University with
Exclusion Criteria:
patients with history of :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To detect risk factors for liver affection in patients with chronic hemolytic anemias presented to the hematology unit.
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
Time frame: 12/2024 - 12/2026
No study locations are listed for this record.
Start is estimated for Dec 2024; primary completion for Oct 2025, 10 months later.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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