Beta Thalassemia Major Anemia
Conditions
Keywords
Beta Thalassemia Major; hypercoagulability; thrombin generation test
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
Interventions
PROCEDUREblood sampling
additional blood sampling for coagulation tests
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed