Thrombophilia In Beta Thalassemia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04219449 |
Recruitment Status :
Not yet recruiting
First Posted : January 7, 2020
Last Update Posted : May 17, 2022
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Condition or disease | Intervention/treatment |
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Beta-Thalassemia | Diagnostic Test: PT Diagnostic Test: Protein C Diagnostic Test: Platelet aggregation by ADP and arachidonic acid |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Thrombophilia Versus Platelet Dysfunction In Beta Thalassemia |
Estimated Study Start Date : | December 31, 2022 |
Estimated Primary Completion Date : | November 30, 2023 |
Estimated Study Completion Date : | December 1, 2023 |

Group/Cohort | Intervention/treatment |
---|---|
study group
Diagnosed beta-thalassemia patients at Assiut University Hospital.
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Diagnostic Test: PT
measuring PT drawn on citrated blood sample Diagnostic Test: Protein C measuring protein C drawn on citrated blood sample Diagnostic Test: Platelet aggregation by ADP and arachidonic acid measuring platelet aggregation drawn on citrated blood sample |
- Hypercoagulability versus platelet dysfunction [ Time Frame: one year ]Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients
- Regular screening of thalassemia patients [ Time Frame: one year ]Evaluation of the significance of implementing regular screening of thalassemia patients for any possible hemostatic changes.

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Ages Eligible for Study: | 4 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219449
Contact: Hanan G Abd El-Azeem, Professor | 01227370520 ext 002 | hanangalal2000@yahoo.com | |
Contact: Sahar A El Gammal, Doctor | 01002342312 ext 002 | Sahar.elgammal@hotmail.com |
Responsible Party: | IM Yousef, Principal Investigator, Assiut University |
ClinicalTrials.gov Identifier: | NCT04219449 |
Other Study ID Numbers: |
TPDBT |
First Posted: | January 7, 2020 Key Record Dates |
Last Update Posted: | May 17, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Thalassemia beta-Thalassemia Thrombophilia Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases |
Hemoglobinopathies Genetic Diseases, Inborn Protein C Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |