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Completed

NCT Number: NCT07486531

Iron Accumulation in Erythrocytes in Patients

Thalassemia refers to a group of blood disorders characterized by a decrease or absence of the synthesis of one or more normal globin chains. Depending on their clinical severity and transfusion requirements, they can be divided into transfusion-dependent and non-transfusion-dependent thalassemias. In patients with beta-thalassemia major, Hb A synthesis is very low, and Hb F constitutes more than 80% of total hemoglobin. These patients are often transfusion-dependent to ensure tissue oxygenation and suppress ineffective erythropoiesis. Transfusion-dependent patients also need to start iron chelation therapy after a period to prevent iron accumulation in the body. While procedures such as liver biopsy and cardiac MRI (magnetic resonance imaging) exist to directly determine tissue iron accumulation, these procedures are invasive, time-consuming, costly, and require a suitable environment. Therefore, the decision to start iron chelation therapy and adjust the dosage is often made by monitoring ferritin levels, which indicate tissue iron accumulation. Serum ferritin is the most commonly used technique for indirectly indicating body iron stores.

Iron accumulation in the body due to frequent transfusions affects not only tissues such as the liver, heart, and nervous system, but also erythroid cells. While previous studies have frequently measured plasma iron not bound to transferrin, also known as labile plasma iron, there are also publications analyzing intracellular labile iron by staining with calcein and using flow cytometry. Another study measured free iron within erythrocytes using HPLC (high-pressure liquid chromatography). However, both HPLC and flow cytometry are expensive and difficult techniques requiring technician expertise and are not available in every laboratory. In our study, we aim to modify the colorimetric method used for traditional iron measurement and measure hemoglobin-free iron in hemolysate samples obtained from erythrocytes. In simpler terms, we aim to detect iron accumulation in the erythrocytes of thalassemia patients who receive frequent transfusions. As is known, serum ferritin monitoring is a parameter that influences the decision to start iron chelation therapy and the treatment dose in thalassemia patients. However, serum ferritin monitoring has some serious disadvantages. Serum ferritin is an indirect indicator of iron overload, showing a nonlinear response to high iron overload; the absence of a decrease in serum ferritin during follow-up does not preclude this response. Furthermore, ferritin is a positive acute phase reactant, and serum levels increase in many cases, making it difficult to differentiate whether the increase in thalassemia patients is due to accumulation or infection. In our study, we aim to directly assess changes in iron overload at the cellular level, as opposed to ferritin, by measuring intracellular iron that is not bound to hemoglobin.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of beta thalassemia major

Exclusion criteria

Samples taken immediately after transfusion

  • insufficient-complete blood count samples
  • patients with thalassemia intermedia
  • patients showing signs of active infection

Treatment and study plan

Primary outcomes

  1. intraerythrocyte non-heme iron level

    Time frame: One month after ethics committee approval

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Evaluation of Non-Hemoglobin-Bound Iron Accumulation in Hemolysates of Thalassemia Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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