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

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ClinicalTrials.gov Identifier: NCT04962984
Recruitment Status : Not yet recruiting
First Posted : July 15, 2021
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Beta Thalassemia Major Anemia Procedure: blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Hypercoagulability by Thrombin Generation Test in Beta-thalassemia Major
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2024


Arm Intervention/treatment
Experimental: THAL +
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).
Procedure: blood sampling
additional blood sampling for coagulation tests

Sham Comparator: THAL -
Patients with beta thalassemia trait, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.
Procedure: blood sampling
additional blood sampling for coagulation tests

Sham Comparator: Healthy volunteers
healthy subjects, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.
Procedure: blood sampling
additional blood sampling for coagulation tests




Primary Outcome Measures :
  1. Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls [ Time Frame: 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 :
  1. Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes [ Time Frame: 6 months ]
    Measurement of the area under the thrombin generation curve before and after transfusion in THAL+ patients over 3 transfusion episodes



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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04962984    
Other Study ID Numbers: CPRC 2017/TG THAL-MARTIN/MS
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Beta Thalassemia Major; hypercoagulability; thrombin generation test
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn