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

Completed

• Conditions: Venous Thromboembolism

• Registration Number: NCT01559207
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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

Study Timeline

• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Study Start: 2013-04
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma free DNA concentration (ng/ml)	5 months	For cohortes T and Px
Plasma nucleosome concentration (ng/ml)	5 months	For cohortes T and Px

Secondary Outcome Measures

Name	Time	Method
blood gamma-glutamyl transaminase (UI/L)	baseline
C reactive protein (mg/l)	6 months
blood fibrinogen (g/l)	6 months
D-dimers (ng/ml)	5 months	cohortes "T" and "Px" only
Fibrin monomers (ng/ml)	5 months	cohortes "T" and "Px" only
creatininemia (µM/L)	6 months
blood Glutamo-oxaloacetate transaminase (UI/L)	6 months
Hemogram	5 months	for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils
blood glutamo-pyruvate transaminase (UI/L)	6 months

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France