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

NCT ID: NCT00481221

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2020-12-31

Brief Summary

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.

Conditions

Thalassemia; Iron Deficiency

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

Screened pregnant women

Observation of results from laboratory tests

Intervention Type: PROCEDURE

Laboratory data summary only

Interventions

Observation of results from laboratory tests

Laboratory data summary only

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Dr Koren Ariel

Head of Pediatric Hematology Unit and Pediatric Dpt B

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariel Koren, MD

Role: STUDY_DIRECTOR

Pediatric Hematology Unit, Ha'Emek Medical Center

Idit Koren, Medical Student

Role: PRINCIPAL_INVESTIGATOR

Pediatric Hematology Unit - Ha'Emek Medical Center

Carina Levin, MD

Role: STUDY_CHAIR

Pediatric Dpt B - Ha'Emek Medical Center

Luci Zalman, PhD

Role: STUDY_CHAIR

Hematology Laboratory - HaEmek Medical Center

Locations

Pediatric Hematology Unit - HaEmek Medical Center

Afula, , Israel

Countries

Israel

Other Identifiers

5210906.EMC

Identifier Type: -

Identifier Source: org_study_id