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Thrombophilia In Beta Thalassemia

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 : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
IM Yousef, Assiut University

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.

Condition or disease Intervention/treatment
Beta-Thalassemia Diagnostic Test: PT Diagnostic Test: Protein C Diagnostic Test: Platelet aggregation by ADP and arachidonic acid

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.

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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 : January 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : January 1, 2021


Group/Cohort Intervention/treatment
study group
Diagnosed beta-thalassemia patients at Assiut University Hospital.
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




Primary Outcome Measures :
  1. Hypercoagulability versus platelet dysfunction [ Time Frame: one year ]
    Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Diagnosed beta-thalassemia patients attending Pediatric Hematology Outpatient Clinic at Assiut University Hospital.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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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

Sponsors and Collaborators
Assiut University

Publications:
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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: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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