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

Not Applicable

Completed

• Conditions: Thalassemic Syndromes
• Interventions: Other: Free α-Hb pool analysis

• Registration Number: NCT02855957
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2015-07
• Study Completion: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-31
• Study First Submitted QC: 2016-07-31
• Last Update Submitted: 2016-07-31
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample	Free α-Hb pool analysis	A blood collection is carry out in the three populations of patients during the day of their enrolment.

Primary Outcome Measures

Name	Time	Method
Correlation between the pool of free α-Hb and genotype α and β -globin of the patient and if necessary with the genotype AHSP gene	Day 1

Secondary Outcome Measures

Name	Time	Method
Correlation between the pool of free α-Hb and Mean Cell Volume	Day 1
Correlation between the pool of free α-Hb and percent of reticulocytes	Day 1
Correlation between the pool of free α-Hb and Mean Corpuscular Hb	Day 1
Correlation between the pool of free α-Hb and Hb value	Day 1
Correlation between the pool of free α-Hb and fetal Hb	Day 1
Correlation between the pool of free α-Hb and erythrocyte enzymes	Day 1

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France