Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

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Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.

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Detailed Description

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Conditions

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Thalassemic Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood sample

A blood collection is carry out in the three populations of patients during the day of their enrolment.

Group Type OTHER

Free α-Hb pool analysis

Intervention Type OTHER

Interventions

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Free α-Hb pool analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Written informed consent
* Affiliation to social security
* Known Hb Phenotypes
* Biological phenotype corresponding to a classical picture of thalassemia

Healthy volunteers

* Age ≥ 18 years
* Written informed consent
* Affiliation to social security

Exclusion Criteria

* Transfusion for less than 3 months
* Chronic active viral disease: hepatitis B, C, HIV
* Ongoing infections or known inflammatory diseases
* Hyper or Hypothyroidism known or subject treated by Levothyrox
* Active pathology or tumor remission for less than 5 years
* Oral corticosteroid
* Hemoglobinopathy other than thalassemia for patients
* Treatment by Hydroxyurea for more than 3 months
* Treatment by stimulating agent erythropoiesis for longer than 3 months

Healthy volunteers

* Transfusion for less than 3 months
* Chronic active viral disease: hepatitis B, C, HIV
* Ongoing infections or known inflammatory diseases
* Hyper or Hypothyroidism known or subject treated by Levothyrox
* Active pathology or tumor remission for less than 5 years
* Oral corticosteroid
* Genetically related to person with hemoglobinopathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes