Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter
Recruitment status was Recruiting
|First Received Date ICMJE||May 31, 2007|
|Last Updated Date||September 3, 2009|
|Start Date ICMJE||March 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00481221 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter|
|Official Title ICMJE||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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Retrospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
All pregant women attending to the Mother's and Child stations in northern Israel
|Intervention ICMJE||Procedure: Observation of results from laboratory tests
Laboratory data summary only
|Study Group/Cohort (s)||1
Screened pregnant women
Intervention: Procedure: Observation of results from laboratory tests
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||300|
|Estimated Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||17 Years to 50 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Israel|
|NCT Number ICMJE||NCT00481221|
|Other Study ID Numbers ICMJE||5210906.EMC|
|Has Data Monitoring Committee||No|
|Responsible Party||Dr Levin Carina, Pediatric Hematology Unit - Ha'Emek Medical Center|
|Study Sponsor ICMJE||HaEmek Medical Center, Israel|
|Collaborators ICMJE||Not Provided|
|Information Provided By||HaEmek Medical Center, Israel|
|Verification Date||September 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP