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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559207
• Other study ID #: LOCAL/2011/SB-02
• Secondary ID: 2011-A01634-37
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: March 25, 2015
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma nucleosome concentration (ng/ml)	For cohortes T and P	baseline	No
Primary	Plasma nucleosome concentration (ng/ml)	For cohortes T and P	6 months	No
Primary	Plasma nucleosome concentration (ng/ml)	For cohortes T and Px	1 month	No
Primary	Plasma nucleosome concentration (ng/ml)	For cohortes T and Px	2 months	No
Primary	Plasma nucleosome concentration (ng/ml)	For cohortes T and Px	3 months	No
Primary	Plasma nucleosome concentration (ng/ml)	For cohortes T and Px	4 months	No
Primary	Plasma nucleosome concentration (ng/ml)	For cohortes T and Px	5 months	No
Primary	Plasma free DNA concentration (ng/ml)	For cohortes T and P	baseline	No
Primary	Plasma free DNA concentration (ng/ml)	For cohortes T and P	6 months	No
Primary	Plasma free DNA concentration (ng/ml)	For cohortes T and Px	1 month	No
Primary	Plasma free DNA concentration (ng/ml)	For cohortes T and Px	2 months	No
Primary	Plasma free DNA concentration (ng/ml)	For cohortes T and Px	3 months	No
Primary	Plasma free DNA concentration (ng/ml)	For cohortes T and Px	4 months	No
Primary	Plasma free DNA concentration (ng/ml)	For cohortes T and Px	5 months	No
Secondary	Hemogram	hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils	baseline	No
Secondary	Hemogram	hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils	6 months	No
Secondary	Hemogram	hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils	1 month	No
Secondary	Hemogram	for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils	2 months	No
Secondary	Hemogram	for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils	3 months	No
Secondary	Hemogram	for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils	4 months	No
Secondary	Hemogram	for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils	5 months	No
Secondary	D-dimers (ng/ml)		baseline	No
Secondary	D-dimers (ng/ml)		6 months	No
Secondary	D-dimers (ng/ml)	cohortes "T" and "Px" only	1 months	No
Secondary	D-dimers (ng/ml)	cohortes "T" and "Px" only	2 months	No
Secondary	D-dimers (ng/ml)	cohortes "T" and "Px" only	3 months	No
Secondary	D-dimers (ng/ml)	cohortes "T" and "Px" only	4 months	No
Secondary	D-dimers (ng/ml)	cohortes "T" and "Px" only	5 months	No
Secondary	Fibrin monomers (ng/ml)		baseline	No
Secondary	Fibrin monomers (ng/ml)		6 months	No
Secondary	Fibrin monomers (ng/ml)	cohortes "T" and "Px" only	1 month	No
Secondary	Fibrin monomers (ng/ml)	cohortes "T" and "Px" only	2 months	No
Secondary	Fibrin monomers (ng/ml)	cohortes "T" and "Px" only	3 months	No
Secondary	Fibrin monomers (ng/ml)	cohortes "T" and "Px" only	4 months	No
Secondary	Fibrin monomers (ng/ml)	cohortes "T" and "Px" only	5 months	No
Secondary	creatininemia (µM/L)		baseline	No
Secondary	creatininemia (µM/L)		6 months	No
Secondary	blood Glutamo-oxaloacetate transaminase (UI/L)		baseline	No
Secondary	blood Glutamo-oxaloacetate transaminase (UI/L)		6 months	No
Secondary	blood glutamo-pyruvate transaminase (UI/L)		baseline	No
Secondary	blood glutamo-pyruvate transaminase (UI/L)		6 months	No
Secondary	blood gamma-glutamyl transaminase (UI/L)		6 months	No
Secondary	blood gamma-glutamyl transaminase (UI/L)		baseline	No
Secondary	C reactive protein (mg/l)		baseline	No
Secondary	C reactive protein (mg/l)		6 months	No
Secondary	blood fibrinogen (g/l)		baseline	No
Secondary	blood fibrinogen (g/l)		6 months	No