Thrombophilia In Beta Thalassemia

NCT04219449 — Unknown, 100 participants, Assiut University

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Thrombophilia Versus Platelet Dysfunction In Beta Thalassemia

RegistryNCT04219449
StatusUnknown
Study typeObservational
Enrollment100 (Estimated)
SponsorAssiut University (Other)
ConditionsBeta-Thalassemia
InterventionsPT, Protein C, Platelet aggregation by ADP and arachidonic acid (Diagnostic test)
Datesstart 2024-05-07 (estimated), primary completion 2024-05-30 (estimated), completion 2024-05-31 (estimated), first posted 2020-01-07, last updated 2024-05-07

Related Papers Related Patents Related Grants Related Experts
All trials for Beta-Thalassemia All trials of PT All trials of Protein C

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
study groupDiagnostic Test: PT; Diagnostic Test: Protein C; Diagnostic Test: Platelet aggregation by ADP and arachidonic acidDiagnosed beta-thalassemia patients at Assiut University Hospital.
  • PT (Diagnostic test): measuring PT drawn on citrated blood sample
  • Protein C (Diagnostic test): measuring protein C drawn on citrated blood sample
  • Platelet aggregation by ADP and arachidonic acid (Diagnostic test): measuring platelet aggregation drawn on citrated blood sample

+Outcome measures

Primary outcomes

  • Hypercoagulability versus platelet dysfunction [one year]: Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients

Secondary outcomes

  • Regular screening of thalassemia patients [one year]: Evaluation of the significance of implementing regular screening of thalassemia patients for any possible hemostatic changes.

+Eligibility

Sex: All, ages: 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.

+Publications

  • 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. PMID 26664743
  • 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. PMID 20712798