Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481221
Status:
UNKNOWN
Last Update Posted:
2019-11-01
First Post:
2007-05-31
Brief Title:
Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
Official Title:
Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter A Clinical Retrospective Study
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15-7 of the world population are carriers for this disease and every year 60000-400000 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None