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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Venous Thromboembolism

Study type: Observational

Funder types: Other

Identifiers

NCT01559207

LOCAL/2011/SB-02

2012-A00198-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The patient or volunteer must have given his/her informed and signed consent
• The patient or volunteer must be insured or beneficiary of a health insurance plan
• The patient or volunteer is available for 6 months of follow-up

For group "P":

• patient with a history of VTE

For group "T":

• healthy volunteer
• no history of VTE
• no history of chronic disease
• no history of neoplastic disease
• no history of chronic infection
• not taking anticoagulants, antiplatelet medications
• no acute disease or infection during the last 2 weeks

Exclusion criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• The patient gave birth in the past three months

Trial design

120 participants in 2 patient groups

Patients with VTE

Description:

Group "P" is composed of all patients with a history of VTE. Group "Px" is a subgroup of 15 patients from group P. Members of "Px" are randomly selected from "P".

Healthy volunteers

Description:

Group "T": 15 healthy volunteers with no history of VTE will be included in this group.