Thrombin Generation in Beta-thalassemia Major

NCT04962984 | Unknown

• 1 other identifier: CPRC 2017/TG THAL-MARTIN/MS
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Beta Thalassemia Major Anemia

Keywords

Beta Thalassemia Major; hypercoagulability; thrombin generation test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 months

Study Arms (3)

THAL +

EXPERIMENTAL

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

THAL -

SHAM COMPARATOR

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

Healthy volunteers

SHAM COMPARATOR

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

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

additional blood sampling for coagulation tests

Healthy volunteers; THAL +; THAL -

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

beta-Thalassemia; Thrombophilia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: July 15, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: July 15, 2021

Record last verified: 2021-06