Thrombin Generation in Beta-thalassemia Major

Central Hospital, Nancy, France45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Beta Thalassemia Major Anemia

Interventions

blood samplingPROCEDURE

additional blood sampling for coagulation tests

Eligibility

Sex: ALLMin age: 10 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 6 months

Secondary Outcomes

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

Time frame: 6 months

Data from ClinicalTrials.gov

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