Thrombophilia In Beta Thalassemia

Beta-Thalassemia Clinical Trial

Official title:

Thrombophilia Versus Platelet Dysfunction In Beta Thalassemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04219449
• Other study ID #: TPDBT
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Beta-Thalassemia
• Thalassemia
• Thrombophilia

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