Thalassaemia Severity

December 3, 2024 updated by: Alzhraa gaber mohamed, Assiut University

Thalassaemia Severity Score in Upper Egypt Patients Attending Assuit University Children Hospital

This study aims to develop a nuanced understanding of thalassemia severity in Upper Egypt by integrating various clinical parameters beyond transfusion frequency. By doing so, it seeks to enhance patient management and ultimately improve quality of life for those affected by this condition.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thalassemia syndrome classified as hemoglobinopathies, represent one of the most prevalent classes of single-gene disorders globally. The mutations in the HBB gene lead to variable impacts on the production of globin proteins, which in turn affects the overall function of hemoglobin. The genetic variants contribute significantly to the diverse clinical presentations and severity of thalassemia. Traditionally, thalassemia has been categorized into Major, intermediate, and Minor based on the frequency of blood transfusions required for survival It has been observed that anemia may not be the sole determinant of thalassemic disease severity, other factors are also responsible for overall clinical status.

Accordingly, clinical conditions of the thalassemia patient, cannot classified based on the transfusion status.

Phadke et al. (2006), proposed a classification that considers multiple parameters beyond transfusion status . Similarly, Sripichai et al , (2008) classified HbE/β-thalassemia into the 3 categories of mild, moderate, and severe. Another classification was also introduced by Thalassemia International Federation (TIF) , which 'was bit modification Sripichai et al 2008 . Despite these advancements, existing classifications still tend to simplify thalassemia into three categories Globally, An estimated 1-5% of the global population are carriers of a genetic thalassemia mutation.Although the epidemiology of the various clinical forms remains poorly recognized, the disease is known to be highly prevalent in the area extending from sub-Saharan Africa, through the Mediterranean region and Middle East, to the Indian subcontinent and East and Southeast Asia.Thus, >90% of patients with these disorders live in low- and middle-income countries

Study Type

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: AlZhraa Gaber Mohamed, Master degree
  • Phone Number: 01091888986 800-555-5555
  • Email: alzhraagaber@gmail.com

Study Contact Backup

  • Name: Khalid Ibrahim Abdrahman El-sayeh, Proffesour
  • Phone Number: 0100 548 4357
  • Email: K.elsayd@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children from 6month till 18years who have thalassaemia

Description

Inclusion Criteria:

- Children and adolescents aged from 18 month to 18 year old. Those with thalassemia

Exclusion Criteria:

  • Non Thalassaemia children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scoring thalassaemia severity
Time Frame: 1year
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Shereen Mansour Galal, Associate professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thalassaemia severity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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