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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481221
First Posted: June 1, 2007
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
  Purpose

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 Intervention
Thalassemia Iron Deficiency Procedure: Observation of results from laboratory tests

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter. A Clinical Retrospective Study.

Resource links provided by NLM:


Further study details as provided by Dr Koren Ariel, HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: March 2007
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Screened pregnant women
Procedure: Observation of results from laboratory tests
Laboratory data summary only

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Israel
Pediatric Hematology Unit - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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
  More Information

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00481221     History of Changes
Other Study ID Numbers: 5210906.EMC
First Submitted: May 31, 2007
First Posted: June 1, 2007
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by Dr Koren Ariel, HaEmek Medical Center, Israel:
Thalassemia
Iron Deficiency
Carrier screening

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Thalassemia
beta-Thalassemia
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn