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

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Unknown status
CT.gov ID
NCT00481221
Collaborator
(none)
30,000
1
166
180.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Observation of results from laboratory tests

Study Design

Study Type:
Observational
Anticipated Enrollment :
30000 participants
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.
Study Start Date :
Mar 1, 2007
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
1

Screened pregnant women

Procedure: Observation of results from laboratory tests
Laboratory data summary only

Outcome Measures

Primary Outcome Measures

  1. Detection of β Thalassemia Carriers by Red Cell Parameters [One year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00481221
Other Study ID Numbers:
  • 5210906.EMC
First Posted:
Jun 1, 2007
Last Update Posted:
Nov 1, 2019
Last Verified:
Oct 1, 2019
Keywords provided by Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2019