Hemolytic Anemia, ChronicNCT06743854
Predisposing Factors for Liver Diseases in Patients With Chronic Hemolytic Anemia
An observational study of Hemolytic Anemia, Chronic and Liver Diseases, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 80 years
- Conditions the study is for
- Hemolytic Anemia, Chronic, Liver Diseases
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 80 years
- All sexes
- Child, Adult, Older adult
Study population: It is cross sectional descriptive study in which all patients with B thalassemia and sickle cell anemia will be included.
Who may be able to join
- All patients presented to Clinical Hematology unit, Internal Medicine Department at Assuit university University with
- thalassemia .
- sickle cell anemia.
Who cannot join
- patients with history of :
- alcohol consumption
- malignancy
- autoimmune hepatitis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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 .
- Conditions
- Hemolytic Anemia, Chronic, Liver Diseases
- Medical subject headings
- Anemia, Hemolytic, Bronchiolitis Obliterans Syndrome, Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12/2024 - 12/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemolytic Anemia, ChronicStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadiea Abdo Bedir Eid, Assiut University
- Investigators
- Mohammed Abbas Al masry, Pro, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743854
- Sponsor's protocol ID
- Chronic hemolytic anemia
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predisposing Factors for Liver Diseases in Patients With Chronic Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT06743854
- Acronym / sponsor ID
- Chronic hemolytic anemia
- Conditions
- Hemolytic Anemia, Chronic, Liver Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 20 Dec 2024 (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.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- It is cross sectional descriptive study in which all patients with B thalassemia and sickle cell anemia will be included.
Key inclusion criteria (3 listed)
- All patients presented to Clinical Hematology unit, Internal Medicine Department at Assuit university University with
Key exclusion criteria (4 listed)
- patients with history of :
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
Mohammed Abbas Al masry, Pro study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolytic Anemia, Chronic and Liver Diseases, run by Assiut University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saadiea Abdo Badir, Resident (01010879993, saadieabedier@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect risk factors for liver affection in patients with chronic hemolytic anemias presented to the hematology unit. (time frame: 12/2024 - 12/2026). 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 27 Dec 2024.