Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia

Thalassemia Clinical Trial

Official title:

Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443312
• Other study ID #: 0047-10-EMC
• Status: Completed
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2019
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The definition of Thalassemia Intermedia is not generally accepted and the specific clinical and laboratory characteristics varies between patients. Some patients are blood transfusion dependent and others are occasionally transfused. Also the mutations in the beta globin gene are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1 gene can affect the clinical course of this disease. The purpose of this study is to summarize the characteristics of patients with Thalassemia Intermedia treated at the Pediatric Hematology Unit at the HaEmek Medical Center in Israel

Description:

The characteristics that will be recorded from the medical files include: demographic data, included gender and ethnic origin, family history, age at diagnosis, number and frequency of blood transfusions including age of first transfusion and physical examination findings.

The laboratory data included iron metabolism parameters, mutation in the alfa and beta gene and the presence of the xmn1 polymorphism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 40 Years

Eligibility

Inclusion Criteria:

-All patients treated at the Pediatric Hematology Unit

Exclusion Criteria:

• Not enough medical records.

• Patients who refuse to give consent to perform genetic studies will be included in the study but only the retrospective clinical data will be recorded.

Related Conditions & MeSH terms

• beta-Thalassemia
• Thalassemia

Intervention

Genetic:
• Laboratory analysis.
The blood transfusions given to the patients are in accord to physician decision and not related to the study

Locations

Country	Name	City	State
Israel	Pediatric Hematology Unit - Ha'Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The characteristics of patients with thalassemia intermedia	Observational study that analyzed the characteristics of thalassemia intermedia patients	One year