Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter

Iron Deficiency Clinical Trial

Official title:

Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter. A Clinical Retrospective Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00481221
• Other study ID #: 5210906.EMC
• Status: Active, not recruiting
• Start date: March 2007
• Est. completion date: December 31, 2020

Study information

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

Clinical Trial Summary

β thalassemia is an autosomal recessive hemoglobinopathy and considered as the most widespread genetic mutation. According to the World Health Organization (WHO) between 1.5-7% of the world population are carriers for this disease, and every year 60,000-400,000 birth of new patients are reported. In Israel, the incidence of carriers for β thalassemia is around 20% among the Jewish from Kurdish origin and around 5-10% among the Arab population.

β thalassemia is a severe disease which requires many resources, both medical and financial. The disease is expressed by chronic hemolytic anemia which requires regular blood transfusions every 3 weeks. As a result of the blood transfusions and the iron absorption by the digestive tract, those patients suffer from severe hemosiderosis which is the main mortality cause in the disease, mainly in the second decade for life. Daily treatment with iron chelator is required. Moreover, despite the actual treatment, the quality of life of those patients is still low.

Therefore the implementation of a prevention program which includes finding an effective and inexpensive way for identifying the β thalassemia carriers is a humanitary and publicly important goal.

In β thalassemia carriers, laboratory tests will show hypochromic microcytic anemia. Those findings are similar in iron deficiency anemia, but the RBC number and the RDW are normal in thalassemia carriers.

Few researchers tried in the past to determine cutoff point for diagnosis of β thalassemia carriers by different formulas.

We used the algorithm SVM (support vector machine) to find a reliable formula that can separate patients with Iron deficiency anemia/ healthy from patients with β thalassemia minor (carriers). This formula can be inserted to any automatic blood counter and search for suspected carriers without deliberately intention and without any further blood test.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 50 Years

Eligibility

Inclusion Criteria:

• Blood count and Hgb electrophoresis analysis received from pregnant women send for screening for thalassemia.

Exclusion Criteria:

• Age below 17 yrs and older than 50 yrs.

• Sever anemia with hgb level below 8 gr/dl.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• beta-Thalassemia
• Iron Deficiency
• Thalassemia

Intervention

Procedure:
• Observation of results from laboratory tests
Laboratory data summary only

Locations

Country	Name	City	State
Israel	Pediatric Hematology Unit - HaEmek 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	Detection of ß Thalassemia Carriers by Red Cell Parameters	Detection of ß Thalassemia Carriers by Red Cell Parameters Obtained From the Automatic blood count counter using mathematics formula	One year