NCT04947540

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 19, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 24, 2021

Last Update Submit

July 13, 2021

Conditions

Outcome Measures

Primary Outcomes (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.

    baseline

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 32391223BACKGROUND
  • 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.

    PMID: 32953110BACKGROUND
  • 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.

    PMID: 27275237BACKGROUND

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mohamed M Ghazally, professor

    Egypt

    STUDY DIRECTOR

Central Study Contacts

Rehab M Rashed, pediatrician

CONTACT

Hekma S Farghaly, Assist. prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 1, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

March 1, 2023

Last Updated

July 19, 2021

Record last verified: 2021-06