Iron Status in BTM With Blood Transfusion

Brief Title

Iron Status in BTM With Blood Transfusion

Official Title

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

Brief 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.
    

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)
    


Study Type

Observational


Primary Outcome

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


Condition

Beta-Thalassemia



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

July 2021

Completion Date

March 2023

Primary Completion Date

July 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Thalassemic patients of both sex.

          -  Beta-thalassemia major patients diagnosed Clinical and laboratory .

          -  Age 5 : 18 years.

          -  Undergoing multiple blood transfusion.

        Exclusion Criteria:

          -  -Age less than 5 years.

          -  Acute illness as fever and infections.
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mohamed M Ghazally, professor, 01064959241, [email protected]



Administrative Informations


NCT ID

NCT04947540

Organization ID

IS in BTM patients


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

Mohamed M Ghazally, professor, Study Director, Egypt


Verification Date

June 2021