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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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