Thrombin Generation in Beta-thalassemia Major
Not Applicable
Not yet recruiting
- Conditions
- Beta Thalassemia Major Anemia
- Registration Number
- NCT04962984
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls 6 months 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)
- Secondary Outcome Measures
Name Time Method Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes 6 months Measurement of the area under the thrombin generation curve before and after transfusion in THAL+ patients over 3 transfusion episodes