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
  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: 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 HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: March 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   17 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481221

Contacts
Contact: Ariel Koren, MD 972-4-6495576 ext 5576 koren_a@clalit.org.il

Locations
Israel
Pediatric Hematology Unit - HaEmek Medical Center Recruiting
Afula, Israel, 18101
Contact: Ariel Koren, MD    972-4-6495576 ext 5576    koren_a@clalit.org.il   
Principal Investigator: Idit Koren, Medical Student         
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

No publications provided

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
Study First Received: May 31, 2007
Last Updated: July 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014