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Completed

NCT Number: NCT01284738

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

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Key information

Conditions

Thalassemia Major (TM) Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Microparticles (MP)Originating From Platelets, Endothelial Cells and Monocytes Thalassemia Thalassemia Intermedia (TI) beta-Thalassemia

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APHM

Marseille, 13, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiopathology

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.

Primary outcomes

  1. Relationship between TM and TI

    Time frame: 36 months

    • 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.

Secondary outcomes

  1. Investigate the mechanisms of the elevated production of MP in thalassemias

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
First posted
Jan 27, 2011
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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