Thrombophilia In Beta Thalassemia

NCT04219449 | Not Yet Recruiting

• 1 other identifier: TPDBT
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Beta-Thalassemia

Outcome Measures

Primary Outcomes (1)

• Hypercoagulability versus platelet dysfunction

  Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients

  one year

Secondary Outcomes (1)

• Regular screening of thalassemia patients

  one year

Study Arms (1)

study group

Diagnosed beta-thalassemia patients at Assiut University Hospital.

Diagnostic Test: PT; Diagnostic Test: Protein C; Diagnostic Test: Platelet aggregation by ADP and arachidonic acid

Interventions

PT DIAGNOSTIC_TEST

measuring PT drawn on citrated blood sample

study group

Protein C DIAGNOSTIC_TEST

measuring protein C drawn on citrated blood sample

study group

Platelet aggregation by ADP and arachidonic acid DIAGNOSTIC_TEST

measuring platelet aggregation drawn on citrated blood sample

study group

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Diagnosed beta-thalassemia patients attending Pediatric Hematology Outpatient Clinic at Assiut University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Hanan G Abd El-Azeem, Professor

CONTACT

01227370520; hanangalal2000@yahoo.com

Sahar A El Gammal, Doctor

CONTACT

01002342312; Sahar.elgammal@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 7, 2020
• Study Start: May 7, 2024
• Primary Completion: May 30, 2024
• Study Completion: May 31, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05