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Clinical Trials/NCT04219449
NCT04219449
Not yet recruiting
Not Applicable

Thrombophilia Versus Platelet Dysfunction In Beta Thalassemia

Assiut University0 sites100 target enrollmentMay 7, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Beta-Thalassemia
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
Hypercoagulability versus platelet dysfunction
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2024
End Date
May 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

IM Yousef

Principal Investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • All blood samples from thalassemia patients before blood transfusion.
  • In splenectomized patients taking Aspirin, the tests will be performed 7 days after discontinuation of the drug.

Exclusion Criteria

  • Patients with other hemoglobinopathies other than beta-thalassemia.
  • Patients suffering from hepatic or cardiac dysfunctions of another aetiology.
  • Patients with history of familial thrombophilia or use of anticoagulant therapy.

Outcomes

Primary Outcomes

Hypercoagulability versus platelet dysfunction

Time Frame: one year

Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients

Secondary Outcomes

  • Regular screening of thalassemia patients(one year)

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