Microparticles (MP)Originating From Platelets, Endothelial Cells and Monocytes Clinical Trial
Official title:
Beta-thalassemia and Microparticles
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
Status | Completed |
Enrollment | 33 |
Est. completion date | |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | APHM | Marseille |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Investigate the mechanisms of the elevated production of MP in thalassemias | Studying the correlation between the number, the activity of erythrocytes and platelets derived-MP and the hemolysis, the dyserythropoiesis, the oxidative stress and iron overload markers. | 36 months | No |