Thrombophilia In Beta Thalassemia

NCT ID: NCT04219449

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-07

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Beta-Thalassemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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study group

Diagnosed beta-thalassemia patients at Assiut University Hospital.

PT

Intervention Type DIAGNOSTIC_TEST

measuring PT drawn on citrated blood sample

Protein C

Intervention Type DIAGNOSTIC_TEST

measuring protein C drawn on citrated blood sample

Platelet aggregation by ADP and arachidonic acid

Intervention Type DIAGNOSTIC_TEST

measuring platelet aggregation drawn on citrated blood sample

Interventions

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PT

measuring PT drawn on citrated blood sample

Intervention Type DIAGNOSTIC_TEST

Protein C

measuring protein C drawn on citrated blood sample

Intervention Type DIAGNOSTIC_TEST

Platelet aggregation by ADP and arachidonic acid

measuring platelet aggregation drawn on citrated blood sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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IM Yousef

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hanan G Abd El-Azeem, Professor

Role: CONTACT

01227370520 ext. 002

Sahar A El Gammal, Doctor

Role: CONTACT

01002342312 ext. 002

References

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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.

Reference Type BACKGROUND
PMID: 26664743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20712798 (View on PubMed)

Other Identifiers

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TPDBT

Identifier Type: -

Identifier Source: org_study_id

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