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OpenTrials
Completed

NCT Number: NCT01559207

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Plasma nucleosome concentration (ng/ml)

    Time frame: baseline

    For cohortes T and P

  2. Plasma nucleosome concentration (ng/ml)

    Time frame: 6 months

    For cohortes T and P

  3. Plasma nucleosome concentration (ng/ml)

    Time frame: 1 month

    For cohortes T and Px

  4. Plasma nucleosome concentration (ng/ml)

    Time frame: 2 months

    For cohortes T and Px

  5. Plasma nucleosome concentration (ng/ml)

    Time frame: 3 months

    For cohortes T and Px

  6. Plasma nucleosome concentration (ng/ml)

    Time frame: 4 months

    For cohortes T and Px

  7. Plasma nucleosome concentration (ng/ml)

    Time frame: 5 months

    For cohortes T and Px

  8. Plasma free DNA concentration (ng/ml)

    Time frame: baseline

    For cohortes T and P

  9. Plasma free DNA concentration (ng/ml)

    Time frame: 6 months

    For cohortes T and P

  10. Plasma free DNA concentration (ng/ml)

    Time frame: 1 month

    For cohortes T and Px

  11. Plasma free DNA concentration (ng/ml)

    Time frame: 2 months

    For cohortes T and Px

  12. Plasma free DNA concentration (ng/ml)

    Time frame: 3 months

    For cohortes T and Px

  13. Plasma free DNA concentration (ng/ml)

    Time frame: 4 months

    For cohortes T and Px

  14. Plasma free DNA concentration (ng/ml)

    Time frame: 5 months

    For cohortes T and Px

Secondary outcomes

  1. Hemogram

    Time frame: baseline

    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  2. Hemogram

    Time frame: 6 months

    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  3. Hemogram

    Time frame: 1 month

    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  4. Hemogram

    Time frame: 2 months

    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  5. Hemogram

    Time frame: 3 months

    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  6. Hemogram

    Time frame: 4 months

    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  7. Hemogram

    Time frame: 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

  8. D-dimers (ng/ml)

    Time frame: baseline

  9. D-dimers (ng/ml)

    Time frame: 6 months

  10. D-dimers (ng/ml)

    Time frame: 1 months

    cohortes "T" and "Px" only

  11. D-dimers (ng/ml)

    Time frame: 2 months

    cohortes "T" and "Px" only

  12. D-dimers (ng/ml)

    Time frame: 3 months

    cohortes "T" and "Px" only

  13. D-dimers (ng/ml)

    Time frame: 4 months

    cohortes "T" and "Px" only

  14. D-dimers (ng/ml)

    Time frame: 5 months

    cohortes "T" and "Px" only

  15. Fibrin monomers (ng/ml)

    Time frame: baseline

  16. Fibrin monomers (ng/ml)

    Time frame: 6 months

  17. Fibrin monomers (ng/ml)

    Time frame: 1 month

    cohortes "T" and "Px" only

  18. Fibrin monomers (ng/ml)

    Time frame: 2 months

    cohortes "T" and "Px" only

  19. Fibrin monomers (ng/ml)

    Time frame: 3 months

    cohortes "T" and "Px" only

  20. Fibrin monomers (ng/ml)

    Time frame: 4 months

    cohortes "T" and "Px" only

  21. Fibrin monomers (ng/ml)

    Time frame: 5 months

    cohortes "T" and "Px" only

  22. creatininemia (µM/L)

    Time frame: baseline

  23. creatininemia (µM/L)

    Time frame: 6 months

  24. blood Glutamo-oxaloacetate transaminase (UI/L)

    Time frame: baseline

  25. blood Glutamo-oxaloacetate transaminase (UI/L)

    Time frame: 6 months

  26. blood glutamo-pyruvate transaminase (UI/L)

    Time frame: baseline

  27. blood glutamo-pyruvate transaminase (UI/L)

    Time frame: 6 months

  28. blood gamma-glutamyl transaminase (UI/L)

    Time frame: 6 months

  29. blood gamma-glutamyl transaminase (UI/L)

    Time frame: baseline

  30. C reactive protein (mg/l)

    Time frame: baseline

  31. C reactive protein (mg/l)

    Time frame: 6 months

  32. blood fibrinogen (g/l)

    Time frame: baseline

  33. blood fibrinogen (g/l)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2012
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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