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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00481221
First received: May 31, 2007
Last updated: July 16, 2013
Last verified: July 2013

May 31, 2007
July 16, 2013
March 2007
December 2014   (final data collection date for primary outcome measure)
Detection of β Thalassemia Carriers by Red Cell Parameters [ Time Frame: One year ] [ Designated as safety issue: No ]
Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the Automatic blood count counter using mathematics formula
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Complete list of historical versions of study NCT00481221 on ClinicalTrials.gov Archive Site
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Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter
Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter. A Clinical Retrospective Study.

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.

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Observational
Time Perspective: Retrospective
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Probability Sample

All pregant women attending to the Mother's and Child stations in northern Israel

  • Thalassemia
  • Iron Deficiency
Procedure: Observation of results from laboratory tests
Laboratory data summary only
1
Screened pregnant women
Intervention: Procedure: Observation of results from laboratory tests
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Female
17 Years to 50 Years
No
Contact: Ariel Koren, MD 972-4-6495576 ext 5576 koren_a@clalit.org.il
Israel
 
NCT00481221
5210906.EMC
No
Dr Koren Ariel, HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Not Provided
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
HaEmek Medical Center, Israel
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP