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

• ClinicalTrials.gov Identifier: NCT00481221
• Recruitment Status: Unknown
• First Posted: June 1, 2007
• Last Update Posted: November 1, 2019
• Sponsor: HaEmek Medical Center, Israel
• Information provided by (Responsible Party): Dr Koren Ariel, HaEmek Medical Center, Israel

Tracking Information

• First Submitted Date: May 31, 2007
• First Posted Date: June 1, 2007
• Last Update Posted Date: November 1, 2019
• Study Start Date: March 2007
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 16, 2013)

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

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter
• Official Title: Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter. A Clinical Retrospective Study.

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: All pregant women attending to the Mother's and Child stations in northern Israel

Condition

• Thalassemia
• Iron Deficiency

Intervention

Procedure: Observation of results from laboratory tests

Laboratory data summary only

Study Groups/Cohorts

1

Screened pregnant women

Intervention: Procedure: Observation of results from laboratory tests

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 30, 2019): 30000
• Original Estimated Enrollment (submitted: May 31, 2007): 300
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 17 Years to 50 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00481221
• Other Study ID Numbers: 5210906.EMC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr Koren Ariel, HaEmek Medical Center, Israel
• Original Responsible Party: Not Provided
• Current Study Sponsor: HaEmek Medical Center, Israel
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: HaEmek Medical Center, Israel
• Verification Date: October 2019