NCT01559207

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Venous Thromboembolism

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-10-20
• Completion: 2014-10-20
• First posted: 2012-03-21
• Last updated: 2025-11-17

Locations

1 site across 1 country: France