Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

Venous Thromboembolism Clinical Trial

Official title: Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

Status Completed

Clinical Trial Summary

The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.

Clinical Trial Description

The secondary objectives of this study are:

A. To describe, for 15 healthy volunteers with no history of venous thromboembolism (VTE), plasma nucleosome and DNA concentrations.

B. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, plasma nucleosome and DNA concentrations.

C. To compare plasma nucleosome and DNA concentrations between healthy volunteers and VTE patients

D. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, the relationships between classification of VTE and plasma nucleosome concentrations:

• anatomical classification of VTE: (i)superficial, deep ((ii)distal or (iii)proximal), or (iv)pulmonary embolism

• circumstantial classification of VTE: (i) triggered, no chronic risk factor; (ii) untriggered, with chronic risk factor; (iii)triggered, with chronic risk factor; (iv) untriggered, no chronic risk factor (idiopathic)

E. To describe, for 100 patients with a history of VTE, the variation in plasma nucleosome concentrations 6 months after the first evaluation

• according to the above anatomical classification

• according to the above circumstantial classification

• according to intercurrent events and treatments

F. To compare the plasma concentrations of nucleosomes and free DNA

G. To evaluate the relationship between plasma nucleosome and free DNA concentrations and:

• circulating leukocyte populations: total leukocyte count, absolute number of neutrophils, monocytes, lymphocytes

• markers of coagulation activation: d-dimers, circulating fibrin monomers

• platelet count

• patients on antivitamin K: INR, patients receiving heparin: antiXa activity

H. Creation of a biological collection ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

• NCT number: NCT01559207
• Study type: Observational
• Source: Centre Hospitalier Universitaire de Nimes
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Completion date: October 2014