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

NCT00481221 | Unknown

• 1 other identifier: 5210906.EMC
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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

Keywords

Thalassemia; Iron Deficiency; Carrier screening

Outcome Measures

Primary Outcomes (1)

• Detection of β Thalassemia Carriers by Red Cell Parameters

  Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the Automatic blood count counter using mathematics formula

  One year

Study Arms (1)

1

Screened pregnant women

Procedure: Observation of results from laboratory tests

Interventions

Observation of results from laboratory tests PROCEDURE

Laboratory data summary only

1

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Blood count and Hgb electrophoresis analysis received from pregnant women send for screening for thalassemia.

You may not qualify if:

• Age below 17 yrs and older than 50 yrs.
• Sever anemia with hgb level below 8 gr/dl.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Pediatric Hematology Unit - HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Thalassemia; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ariel Koren, MD

  Pediatric Hematology Unit, Ha'Emek Medical Center

  STUDY DIRECTOR

• Idit Koren, Medical Student

  Pediatric Hematology Unit - Ha'Emek Medical Center

  PRINCIPAL INVESTIGATOR

• Carina Levin, MD

  Pediatric Dpt B - Ha'Emek Medical Center

  STUDY CHAIR

• Luci Zalman, PhD

  Hematology Laboratory - HaEmek Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Hematology Unit and Pediatric Dpt B

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 1, 2007
• Study Start: March 1, 2007
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

IL (1)