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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04219449
Other study ID # TPDBT
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 7, 2024
Est. completion date May 31, 2024

Study information

Verified date May 2024
Source Assiut University
Contact Hanan G Abd El-Azeem, Professor
Phone 01227370520
Email hanangalal2000@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

β-thalassemia disease is one of the most common congenital hemolytic anemia commonly found in the malarial belt areas including the Mediterranean, the Middle East, Africa, Southeast Asian countries, and China.


Description:

β-thalassemia represents a major public health problem in Egypt, it is estimated that there are 1000/1.5 million per year live births born with β-thalassemia. The average life expectancy of patients with β-thalassemia has improved over the last few years as compared to that of in the previous millennium. This has led to the discovery of new set of problems such as increased hypercoagulable state in β-thalassemia like micro infarcts in spleen and lung indicating an activated coagulation pathway. The, incidence of thromboembolism in patients with thalassemia disease is approximately 10 times higher than normal population, it accounts between 1.7 and 9.2%. On the other hand, a study conducted by Chaudhary and Ahmad, 2012 showed decreased aggregation in majority of β-thalassemia patients. Another study conducted by Ibrahim, 1999 had noticed few patients to have bleeding manifestations in the form of epistaxis. Mussumeci et al., 1987 noted that both thrombophilic and anti-thrombophilic proteins were reduced as a consequence of liver damage. The net clinical outcome depends on the fine balance between the prothrombotic and antithrombotic pathways.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 31, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers
Gender All
Age group 4 Years to 20 Years
Eligibility Inclusion Criteria: 1. All blood samples from thalassemia patients before blood transfusion. 2. In splenectomized patients taking Aspirin, the tests will be performed 7 days after discontinuation of the drug. Exclusion Criteria: 1. Patients with other hemoglobinopathies other than beta-thalassemia. 2. Patients suffering from hepatic or cardiac dysfunctions of another aetiology. 3. Patients with history of familial thrombophilia or use of anticoagulant therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
PT
measuring PT drawn on citrated blood sample
Protein C
measuring protein C drawn on citrated blood sample
Platelet aggregation by ADP and arachidonic acid
measuring platelet aggregation drawn on citrated blood sample

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Cappellini MD, Motta I, Musallam KM, Taher AT. Redefining thalassemia as a hypercoagulable state. Ann N Y Acad Sci. 2010 Aug;1202:231-6. doi: 10.1111/j.1749-6632.2010.05548.x. — View Citation

Winichakoon P, Tantiworawit A, Rattanathammethee T, Hantrakool S, Chai-Adisaksopha C, Rattarittamrong E, Norasetthada L, Charoenkwan P. Prevalence and Risk Factors for Complications in Patients with Nontransfusion Dependent Alpha- and Beta-Thalassemia. Anemia. 2015;2015:793025. doi: 10.1155/2015/793025. Epub 2015 Nov 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hypercoagulability versus platelet dysfunction Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients one year
Secondary Regular screening of thalassemia patients Evaluation of the significance of implementing regular screening of thalassemia patients for any possible hemostatic changes. one year
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