Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter
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|ClinicalTrials.gov Identifier: NCT00481221|
Recruitment Status : Unknown
Verified October 2019 by Dr Koren Ariel, HaEmek Medical Center, Israel.
Recruitment status was: Active, not recruiting
First Posted : June 1, 2007
Last Update Posted : November 1, 2019
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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.
|Condition or disease||Intervention/treatment|
|Thalassemia Iron Deficiency||Procedure: Observation of results from laboratory tests|
|Study Type :||Observational|
|Estimated Enrollment :||30000 participants|
|Official Title:||Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter. A Clinical Retrospective Study.|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Screened pregnant women
Procedure: Observation of results from laboratory tests
Laboratory data summary only
- Detection of β Thalassemia Carriers by Red Cell Parameters [ Time Frame: One year ]Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the Automatic blood count counter using mathematics formula
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|Ages Eligible for Study:||17 Years to 50 Years (Child, Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Blood count and Hgb electrophoresis analysis received from pregnant women send for screening for thalassemia.
- Age below 17 yrs and older than 50 yrs.
- Sever anemia with hgb level below 8 gr/dl.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481221
|Pediatric Hematology Unit - HaEmek Medical Center|
|Afula, Israel, 18101|
|Study Director:||Ariel Koren, MD||Pediatric Hematology Unit, Ha'Emek Medical Center|
|Principal Investigator:||Idit Koren, Medical Student||Pediatric Hematology Unit - Ha'Emek Medical Center|
|Study Chair:||Carina Levin, MD||Pediatric Dpt B - Ha'Emek Medical Center|
|Study Chair:||Luci Zalman, PhD||Hematology Laboratory - HaEmek Medical Center|
|Responsible Party:||Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel|
|Other Study ID Numbers:||
|First Posted:||June 1, 2007 Key Record Dates|
|Last Update Posted:||November 1, 2019|
|Last Verified:||October 2019|
Iron Metabolism Disorders
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn