NCT01284738|Completed
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Sponsor study identifier
Secondary identifiers
interventional
33
1 country
1
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
Not reported
Date not reportedThe 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
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Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 26, 2011
Actual (reported)January 27, 2011
Actual (reported)February 2014
Actual (reported)Relationship between TM and TI
* In TM, to quantify the elevation of MP as well as their procoagulant activity, to describe their production kinetic, to determine the transfusional or endogenous origin of erythrocytic MP and finally to compare their characteristics with those found in TI patients. * To study, in TM and TI patients, the relationship between the number, the procoagulant activity of MP and the clinical (thromboembolic episodes,splenectomy, presence of pulmonary hypertension) biological and plasmatic data reflecting the patient's prothrombotic state.
36 months
Investigate the mechanisms of the elevated production of MP in thalassemias
36 months
thalassemia major (TM) Need transfusion for survive
thalassemia intermedia (TI) Patients with TI have a milder clinical phenotype than those with TM
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.
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.
APHM
Marseille, 13, France
Isabelle Thuret, Doctor
APHM
33 participants (actual enrollment reported by the registry).
First Submitted
January 26, 2011
First Posted
January 27, 2011
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation
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Primary Completion
February 2014
Actual (reported)Last Updated
August 29, 2014
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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