Thrombin Generation in Beta-thalassemia Major

Beta Thalassemia Major Anemia Clinical Trial

— TG-THAL  

Official title:

Evaluation of Hypercoagulability by Thrombin Generation Test in Beta-thalassemia Major

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04962984
• Other study ID #: CPRC 2017/TG THAL-MARTIN/MS
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Beta Thalassemia Major Anemia
• beta-Thalassemia
• Thalassemia

Intervention

Procedure:
• blood sampling
additional blood sampling for coagulation tests

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Secondary	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	6 months