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Thrombophilia In Beta Thalassemia

Thrombophilia Versus Platelet Dysfunction In Beta Thalassemia

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04219449
Enrollment
100
Registered
2020-01-07
Start date
2024-05-07
Completion date
2024-05-31
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-Thalassemia

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.

Interventions

DIAGNOSTIC_TESTPlatelet aggregation by ADP and arachidonic acid

measuring platelet aggregation drawn on citrated blood sample

DIAGNOSTIC_TESTPT

measuring PT drawn on citrated blood sample

DIAGNOSTIC_TESTProtein C

measuring protein C drawn on citrated blood sample

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
4 Years to 20 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Hypercoagulability versus platelet dysfunctionone yearPredominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients

Secondary

MeasureTime frameDescription
Regular screening of thalassemia patientsone yearEvaluation of the significance of implementing regular screening of thalassemia patients for any possible hemostatic changes.

Contacts

Primary ContactHanan G Abd El-Azeem, Professor
hanangalal2000@yahoo.com01227370520
Backup ContactSahar A El Gammal, Doctor
Sahar.elgammal@hotmail.com01002342312

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026