Thrombin Generation in Beta-thalassemia Major (TG-THAL)

Central Hospital, Nancy, France

Status: Not yet enrolling

Conditions: Beta Thalassemia Major Anemia

Treatments: Procedure: blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04962984

CPRC 2017/TG THAL-MARTIN/MS

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 10 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

THAL +

Experimental group

Description:

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).

Treatment:

Procedure: blood sampling

THAL -

Sham Comparator group

Description:

Patients with beta thalassemia trait, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.

Treatment:

Procedure: blood sampling

Healthy volunteers

Sham Comparator group

Description:

healthy subjects, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.

Treatment:

Procedure: blood sampling