Study on the Effect of Different Risk Factors on the Growth Parameters of Thalassemic Patients in Assiut (AUCH)

NCT05303506 | Unknown

• 1 other identifier: thalassemia in AUCH
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the effect of different risk factors on the growth parameters of thalassemic patients in Assiut University children Hospital (AUCH) In order to help in decreasing the morbidity and mortality resulting from iron overload and improving the quality of life for thalassemic patient

Conditions

Thalassemia Major

Outcome Measures

Primary Outcomes (2)

• Measuring the Effect of different risk factors on the Growth Parameters of Thalassemic Patients in Assiut University Children Hospital (AUCH) and how these risk factors affect the quality of life by measuring anthropocentric measures

  Data of the patients will be collected from thalassemic patients in form of 1. Personal history (Name, Age ,Sex) 2. Therapeutic history (Age of diagnosis , Age of 1st chelator ,Chelator type , Chelator dose , Compliance to treatment ) 3. Growth parameters (Weight , Height,and mid arm circumference))

  2 years

• Decreasing the morbidity and mortality and improving the quality of life for thalassemic patient

  At the end of the study there will be recommendations to help in decreasing the morbidity and mortality and improving the quality of life for thalassemic patient

  6 months

Interventions

serum ferritin and AST DIAGNOSTIC_TEST

observiational study

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children attending haematology unit in Assiut University Children Hospital with thalassemia treated by iron chelating agents and aged from one year to 16 years old.

You may qualify if:

• All children attending haematology unit in Assiut University Children Hospital with thalassemia treated by iron chelating agents and aged from one year to 16 years old.

You may not qualify if:

• Children not treated by chelating agents. Children with stem cell transplantation . Children with thalassemia minor or intermedia.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• . Pemde et al, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. Pediatric Health, Medicine and Therapeutics 2011:2 13-19

  BACKGROUND

• Hoffbrand AV, Taher A, Cappellini MD. How I treat transfusional iron overload. Blood. 2012 Nov 1;120(18):3657-69. doi: 10.1182/blood-2012-05-370098. Epub 2012 Aug 23.

  PMID: 22919029 BACKGROUND

• Rachmilewitz EA, Giardina PJ. How I treat thalassemia. Blood. 2011 Sep 29;118(13):3479-88. doi: 10.1182/blood-2010-08-300335. Epub 2011 Aug 2.

  PMID: 21813448 BACKGROUND

• Najafipour F, Aliasgarzadeh A, Aghamohamadzadeh N, Bahrami A, Mobasri M, Niafar M, Khoshbaten M. A cross-sectional study of metabolic and endocrine complications in beta-thalassemia major. Ann Saudi Med. 2008 Sep-Oct;28(5):361-6. doi: 10.5144/0256-4947.2008.361.

  PMID: 18779644 BACKGROUND

• Wood JC, Kang BP, Thompson A, Giardina P, Harmatz P, Glynos T, Paley C, Coates TD. The effect of deferasirox on cardiac iron in thalassemia major: impact of total body iron stores. Blood. 2010 Jul 29;116(4):537-43. doi: 10.1182/blood-2009-11-250308. Epub 2010 Apr 26.

  PMID: 20421452 BACKGROUND

• Deugnier Y, Turlin B, Ropert M, Cappellini MD, Porter JB, Giannone V, Zhang Y, Griffel L, Brissot P. Improvement in liver pathology of patients with beta-thalassemia treated with deferasirox for at least 3 years. Gastroenterology. 2011 Oct;141(4):1202-11, 1211.e1-3. doi: 10.1053/j.gastro.2011.06.065. Epub 2011 Jul 7.

  PMID: 21741344 BACKGROUND

• Cabantchik ZI, Breuer W, Zanninelli G, Cianciulli P. LPI-labile plasma iron in iron overload. Best Pract Res Clin Haematol. 2005 Jun;18(2):277-87. doi: 10.1016/j.beha.2004.10.003.

  PMID: 15737890 BACKGROUND

• Borgna-Pignatti C. Surviving with thalassemia major: the Italian experience. Pediatr Hematol Oncol. 2007 Jan-Feb;24(1):75-8. doi: 10.1080/08880010601001461. No abstract available.

  PMID: 17130117 BACKGROUND

• Wood JC, Enriquez C, Ghugre N, Tyzka JM, Carson S, Nelson MD, Coates TD. MRI R2 and R2* mapping accurately estimates hepatic iron concentration in transfusion-dependent thalassemia and sickle cell disease patients. Blood. 2005 Aug 15;106(4):1460-5. doi: 10.1182/blood-2004-10-3982. Epub 2005 Apr 28.

  PMID: 15860670 BACKGROUND

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mohamed Elmostafa Mohamed Hemida, master degree

CONTACT

+201097602949; mhemida92@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mhemida92@gmail.com (resident physician of pediatrics)

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: March 31, 2022
• Study Start: July 2, 2022
• Primary Completion: December 2, 2023
• Study Completion: March 2, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share