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

NCT ID: NCT01559207

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-10-20

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

Conditions

Venous Thromboembolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with VTE

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".

No interventions assigned to this group

Healthy volunteers

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Bouvier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

Bouvier S, Bastide S, Chouirfa S, Nouvellon E, Mercier E, Bigot L, Lavigne G, Cayla G, Perez-Martin A, Gris JC. Reliability of hemostasis biomarkers is affected by time-dependent intra-patient variability. J Thromb Haemost. 2018 Jun 8. doi: 10.1111/jth.14198. Online ahead of print.

Reference Type: RESULT

PMID: 29883046 (View on PubMed)

Other Identifiers

2012-A00198-35

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2011/SB-02

Identifier Type: -

Identifier Source: org_study_id