Thrombin Generation in Beta-thalassemia Major

Study Overview
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Brief Summary
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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

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

Conditions
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Beta Thalassemia Major Anemia

Intervention / Treatment
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* Procedure: blood sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THAL +<br>patients with beta thalassemia major, requiring blood transfusion regimen. Additional blood sampling will be performed before and immediately after transfusion (21 millilters and 24 millilters respectively), on the occasion of 3 programed transfusions (consecutive or not). | Procedure: blood sampling<br>* additional blood sampling for coagulation tests<br>|
| Sham Comparator: THAL -<br>Patients with beta thalassemia trait, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed. | Procedure: blood sampling<br>* additional blood sampling for coagulation tests<br>|
| Sham Comparator: Healthy volunteers<br>healthy subjects, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed. | Procedure: blood sampling<br>* additional blood sampling for coagulation tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls | Measurement of the area under the thrombin generation curve (ie ETP) in THAL+ patients, before and after transfusion, as compared with ETP measured in controls groups (THAL- and healthy volunteers) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes | Measurement of the area under the thrombin generation curve before and after transfusion in THAL+ patients over 3 transfusion episodes | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta Thalassemia Major; hypercoagulability; thrombin generation test