Thrombin Generation in Beta-thalassemia Major

Not Applicable

Not yet recruiting

• Conditions: Beta Thalassemia Major Anemia
• Interventions: Procedure: blood sampling

• 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

Study Timeline

• Study First Submitted: 2018-09-24
• Status Verified: 2021-06
• Study First Submitted QC: 2021-07-05
• Last Update Submitted: 2021-07-05
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15
• Study Start: 2021-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2024-09-01

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

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	blood sampling	healthy subjects, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.
THAL +	blood sampling	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).
THAL -	blood sampling	Patients with beta thalassemia trait, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.

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