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Beta-ThalassemiaNCT04947540

Iron Status in BTM With Blood Transfusion

An observational study of Beta-Thalassemia, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess the possible role of iron overload as a cause of liver dysfunction in thalassemic childrens receiving multiple blood transfusion and its correlation with serum aminotransferases. Read more about this study

Who is it for?
Ages 5 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Beta-Thalassemia
How many people
100 participants
Where
No sites listed yet
Study dates
Jul 2021to Mar 2023
Phase
Observational
Are there results?
None posted in the registry

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 5 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: all cases diagnosed as thalassemia major attending to thalassemic center at hematological department at Assuit university childern hospital.

Who may be able to join

  • Thalassemic patients of both sex.
  • Beta-thalassemia major patients diagnosed Clinical and laboratory .
  • Age 5 : 18 years.
  • Undergoing multiple blood transfusion.

Who cannot join

  • -Age less than 5 years.
  • Acute illness as fever and infections.

Trial locations and contacts

No sites are listed yet.

Rehab M Rashed, pediatrician contact

01064959241 ext. Egypt

rhabrashed950@gmail.com

Hekma S Farghaly, Assist. prof contact

01091251040 ext. Egypt

Hekma.osman@med.au.edu.eg

About this study

Official title: Hematological and Biochemical Markers of Iron Status in Thalassemic Children Receiving Multiple Blood Transfusion

To assess the possible role of iron overload as a cause of liver dysfunction in thalassemic childrens receiving multiple blood transfusion and its correlation with serum aminotransferases.

Read the detailed description

Thalassemia is derived from the Greek words, thals, which means sea, and emia, which means blood, signifying that it is more common in the Mediterranean region . Globally, among humans, thalassemia is the commonest single-gene disorder. It is defined as a group of inherited disorders characterized by decreased or absent beta globin chain synthesis, leading to a reduced level of hemoglobulin (Hb) in the red blood cells . Specifically in developing countries, thalassemia is a huge health dilemma.

-Beta Thalassemia is the most common chronic hemolytic anemia in Egypt (85.1%) with an estimated carrier rate of 9-10.2%.

Blood transfusion is the primary way of treating thalassemia; it allows the normal growth of the child as well as restrains abnormal erythropoiesis . Iron-chelating agents should be used properly;otherwise, multiple blood transfusions can lead to iron overload. Yet, with no blood transfusion, the increase rate of erythropoiesis intensifies dietary iron absorption from the gut, leading to a severe form of iron overload .

iron overload can result in serious damage to various organs, for example, by depositing in the liver, heart, and various other endocrine glands along with endocrine organ failure. .

During the last years, liver disease has emerged as a major cause of mortality in patients with B- thalassemia major (TM).

The liver is the only site for ferritin and transferrin synthesis, as well as the primary organ for iron storage.

The liver has the maximum capacity to store excess iron in the body, and various other organs, as well as the liver, are very susceptible to damage as a result of iron toxicity.

The correlation between serum ferritin and hepatic iron concentration has been reported in multiple blood-transfused thalassemia patients .

Thalassemia major patients who undergo routine transfusion have an increased risk of acquiring transfusion-transmitted infections (TTI), including hepatitis B and C. These diseases have serious implications and may affect the serum ferritin and aminotransferase levels of thalassemia major patients.

Although the risk of post-transfusion hepatitis C virus (HCV) infection dropped significantly after the national screening of blood in 1993, more than 20% of children who were multitransfused after that date were HCV-RNA positive .

In Egypt, prevalence rate of HCV antibodies seropositivity in thalassemic children at 2011was 51.7% while in the study of El-Faramawy (2012) , a prevalence of 48 % was reported.

Iron overload and hepatitis-C virus (HCV) infection, have been implicated in the evolution of liver disease, in patients with transfusion-dependent beta-thalassaemia major (BTM). The impact of these factors and liver with BTM, has not been extensively studied yet.

Hepatitis virus C infection is the main risk factor for liver injury in transfusion-dependent thalassemics . Dimitrios (2013) on the other hand suggested that in the late stages of liver disease in BTM patients, iron overload may be the critical determinant, since fibrosis is related to the minimal haemosiderosis, independently of HCV history. Injury to the liver, whether acute or chronic, eventually results in an increase in serum concentrations of Alanine transaminase (ALT) and Aspartate transaminase (AST)

Medical subject headings
beta-Thalassemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematological and biochemical markers of Iron status in thalassemic children receiving multiple blood transfusion

    Assessment the possible role of iron overload as a cause of liver dysfunction in thalassemic childrens receiving multiple blood transfusion and its correlation with serum aminotransferases.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2021
  2. Study startJul 2021 (estimated)
  3. Primary completionJul 2022 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04947540
Sponsor's protocol ID
IS in BTM patients
Status last verified
Jun 2021
First submitted
24 Jun 2021
Last updated
19 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Al-Moshary M, Imtiaz N, Al-Mussaed E, Khan A, Ahmad S, Albqami S. Clinical and Biochemical Assessment of Liver Function Test and Its Correlation with Serum Ferritin Levels in Transfusion-dependent Thalassemia Patients. Cureus. 2020 Apr 7;12(4):e7574. doi: 10.7759/cureus.7574.

    PubMed 32391223
  • Amjad F, Fatima T, Fayyaz T, Khan MA, Qadeer MI. Novel genetic therapeutic approaches for modulating the severity of beta-thalassemia (Review). Biomed Rep. 2020 Nov;13(5):48. doi: 10.3892/br.2020.1355. Epub 2020 Sep 2.

    PubMed 32953110
  • Salama KM, Ibrahim OM, Kaddah AM, Boseila S, Ismail LA, Hamid MM. Liver Enzymes in Children with beta-Thalassemia Major: Correlation with Iron Overload and Viral Hepatitis. Open Access Maced J Med Sci. 2015 Jun 15;3(2):287-92. doi: 10.3889/oamjms.2015.059. Epub 2015 May 28.

    PubMed 27275237

Questions about this trial

What is this clinical trial studying?

An observational study of Beta-Thalassemia, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rehab M Rashed, pediatrician (01064959241 ext. Egypt, rhabrashed950@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematological and biochemical markers of Iron status in thalassemic children receiving multiple blood transfusion (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04947540, which also lists 3 linked publications.

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 19 Jul 2021.

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