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

Primary Purpose

Beta Thalassemia Major Anemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood sampling
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Beta Thalassemia Major Anemia focused on measuring Beta Thalassemia Major; hypercoagulability; thrombin generation test

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    Sham Comparator

    Arm Label

    THAL +

    THAL -

    Healthy volunteers

    Arm 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).

    Patients with beta thalassemia trait, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.

    healthy subjects, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 24, 2018
    Last Updated
    July 5, 2021
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04962984
    Brief Title
    Thrombin Generation in Beta-thalassemia Major
    Acronym
    TG-THAL
    Official Title
    Evaluation of Hypercoagulability by Thrombin Generation Test in Beta-thalassemia Major
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Beta Thalassemia Major Anemia
    Keywords
    Beta Thalassemia Major; hypercoagulability; thrombin generation test

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    THAL +
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    THAL -
    Arm Type
    Sham Comparator
    Arm Description
    Patients with beta thalassemia trait, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.
    Arm Title
    Healthy volunteers
    Arm Type
    Sham Comparator
    Arm Description
    healthy subjects, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed.
    Intervention Type
    Procedure
    Intervention Name(s)
    blood sampling
    Intervention Description
    additional blood sampling for coagulation tests
    Primary Outcome Measure Information:
    Title
    Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls
    Description
    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)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes
    Description
    Measurement of the area under the thrombin generation curve before and after transfusion in THAL+ patients over 3 transfusion episodes
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Thrombin Generation in Beta-thalassemia Major

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