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

July 5, 2021 updated by: Central Hospital, Nancy, France

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPRC 2017/TG THAL-MARTIN/MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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