Thrombophilia In Beta Thalassemia

Not yet recruiting

• Conditions: Beta-Thalassemia
• Interventions: Diagnostic Test: PT; Diagnostic Test: Protein C; Diagnostic Test: Platelet aggregation by ADP and arachidonic acid

• Registration Number: NCT04219449
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2020-01-04
• Study First Posted: 2020-01-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-05
• Study Start: 2024-05-07
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	PT	Diagnosed beta-thalassemia patients at Assiut University Hospital.
study group	Protein C	Diagnosed beta-thalassemia patients at Assiut University Hospital.
study group	Platelet aggregation by ADP and arachidonic acid	Diagnosed beta-thalassemia patients at Assiut University Hospital.

Primary Outcome Measures

Name	Time	Method
Hypercoagulability versus platelet dysfunction	one year	Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients

Secondary Outcome Measures

Name	Time	Method
Regular screening of thalassemia patients	one year	Evaluation of the significance of implementing regular screening of thalassemia patients for any possible hemostatic changes.