Thrombin Generation in Beta-thalassemia Major

Evaluation of Hypercoagulability by Thrombin Generation Test in Beta-thalassemia Major

NCT04962984•Central Hospital, Nancy, France

Summary

This study aims to evaluate the persistence of a hypercoagulable state in chronically-transfused patients with beta thalassemia major, by using the thrombin generation test (performed in whole blood and plasma). Patients will be compared with 2 control groups: 1/ healthy volunteers and 2/ carriers of beta-thalassemia trait

Eligibility

Age

10 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Patient with de Beta-thalassemia major
•Patient with regular blood transfusion regimen (every 4 - 6 weeks)
•informed and signed consent
•weight \> 30kg
•Hemoglobin \> 7g/dL

Exclusion Criteria

•Emergency situation
•Patients receiving antithrombotic drugs (anticoagulants such as Vitamin K antagonism, heparin or direct oral anticoagulant) or antiplatelet drugs;
•women of childbearing age without contraception
•pregnancy
•deprivation of liberty
•no consent

Key Dates

Start Date

September 1, 2021

Primary Completion Date

September 1, 2023

Completion Date

September 1, 2024

Last Updated

July 15, 2021

Enrollment

ESTIMATED participants

Conditions

Beta Thalassemia Major Anemia

Interventions

blood sampling

PROCEDURE