Thrombin Generation in Beta-thalassemia Major

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Brief Title

Thrombin Generation in Beta-thalassemia Major

Official Title

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

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
    



Study Type

Interventional


Primary Outcome

Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls

Secondary Outcome

 Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes

Condition

Beta Thalassemia Major Anemia

Intervention

blood sampling

Study Arms / Comparison Groups

 THAL +
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

45

Start Date

September 1, 2021

Completion Date

September 1, 2024

Primary Completion Date

September 1, 2023

Eligibility Criteria

        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
      

Gender

All

Ages

10 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 



Administrative Informations


NCT ID

NCT04962984

Organization ID

CPRC 2017/TG THAL-MARTIN/MS


Responsible Party

Sponsor

Study Sponsor

Central Hospital, Nancy, France


Study Sponsor

, , 


Verification Date

June 2021