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Beta-thalassemia and Microparticles

NCT ID: NCT01284738

Last Updated: 2014-08-29

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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The results will allow us to evaluate the role of MP in the thrombo-embolic risk observed in thalassemic patients and to underline a possible difference between TM and TI. The in vitro and in vivo study of MP in erythrocytes concentrates is a new approach to explore the consequence of transfusion in polytransfused patients. Finally, the identification of a possible relationship between the oxidative stress and the production of MP may lead to the development of specific therapeutical approaches

Detailed Description

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Microparticles (MP) are intact vesicles derived from cell membranes which arise mainly through cell membrane activation processes and from apoptosis. MP originating from platelets, endothelial cells and monocytes have been most extensively studied, though similar particles can arise from red cells and granulocytes. The ability to form microparticles is an essential part of physiological coagulation.However, MP may play an important procoagulant role in several diseases including sickle cell disease, and paroxysmal nocturnal haemoglobinuria (PNH).

Several studies reported the presence of MP in TI and their potential role in the hypercoagulable state. The investigators propose in this study to investigate the presence and origin of MP in TM patients.

Conditions

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Thalassemia Major (TM) Thalassemia Intermedia (TI) Microparticles (MP)Originating From Platelets, Endothelial Cells and Monocytes

Keywords

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TM TI MP

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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TM patients

thalassemia major (TM) Need transfusion for survive

Group Type ACTIVE_COMPARATOR

Physiopathology

Intervention Type OTHER

Three sequential biological evaluations will be performed for each patient and will consist in :

* the dosages of MP carried out by the UMR 608 in Marseille,
* the evaluation of the oxidative stress markers and of iron performed in the UMR 773 in Paris-Bichat.

In vitro production of MP of transfused red blood cells origin will also be evaluated in erythrocytes concentrates during the storage of the units.

TI patients

thalassemia intermedia (TI) Patients with TI have a milder clinical phenotype than those with TM

Group Type ACTIVE_COMPARATOR

Physiopathology

Intervention Type OTHER

Three sequential biological evaluations will be performed for each patient and will consist in :

* the dosages of MP carried out by the UMR 608 in Marseille,
* the evaluation of the oxidative stress markers and of iron performed in the UMR 773 in Paris-Bichat.

Interventions

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Physiopathology

Three sequential biological evaluations will be performed for each patient and will consist in :

* the dosages of MP carried out by the UMR 608 in Marseille,
* the evaluation of the oxidative stress markers and of iron performed in the UMR 773 in Paris-Bichat.

In vitro production of MP of transfused red blood cells origin will also be evaluated in erythrocytes concentrates during the storage of the units.

Intervention Type OTHER

Physiopathology

Three sequential biological evaluations will be performed for each patient and will consist in :

* the dosages of MP carried out by the UMR 608 in Marseille,
* the evaluation of the oxidative stress markers and of iron performed in the UMR 773 in Paris-Bichat.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient recorded in the national register of the patients attained by beta-thalassemia (TI) or (TM)
* Patient monitoring in one of 5 recruiters centers
* Patient more than 15 years
* Patient consented and informed

Exclusion Criteria

* Blood transfusion dating from less than 3 months for TI
* Composite Heterozygotes HbE /beta-thalassemia
* pregnant women
* other disease
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle Thuret, Doctor

Role: STUDY_DIRECTOR

APHM

Locations

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APHM

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2009-18

Identifier Type: -

Identifier Source: secondary_id

2010-A00198-31

Identifier Type: -

Identifier Source: org_study_id