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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00198-35 | Other Identifier | ANSM |
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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.
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:
E. To describe, for 100 patients with a history of VTE, the variation in plasma nucleosome concentrations 6 months after the first evaluation
F. To compare the plasma concentrations of nucleosomes and free DNA
G. To evaluate the relationship between plasma nucleosome and free DNA concentrations and:
H. Creation of a biological collection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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". | ||
| Healthy volunteers | Group "T": 15 healthy volunteers with no history of VTE will be included in this group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma nucleosome concentration (ng/ml) | For cohortes T and P | baseline |
| Plasma nucleosome concentration (ng/ml) | For cohortes T and P | 6 months |
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 1 month |
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 2 months |
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 3 months |
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 4 months |
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 5 months |
| Plasma free DNA concentration (ng/ml) | For cohortes T and P | baseline |
| Plasma free DNA concentration (ng/ml) | For cohortes T and P |
| Measure | Description | Time Frame |
|---|---|---|
| Hemogram | hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | baseline |
| Hemogram |
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Inclusion Criteria:
For group "P":
For group "T":
Exclusion Criteria:
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The study population is composed of 15 healthy volunteers with no history of VTE (group "T") and 100 patients with VTE (group "P"). Fifteen randomly selected members of group P make up the sub-group "Px".
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Bouvier, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29883046 | Result | 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. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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EDTA, CTAD and dry tubes; Biological collection at the Nîmes University Hospital.
| 6 months |
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 1 month |
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 2 months |
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 3 months |
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 4 months |
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 5 months |
hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils
| 6 months |
| Hemogram | hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | 1 month |
| 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 |
| 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 |
| 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 |
| 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 |
| D-dimers (ng/ml) | baseline |
| D-dimers (ng/ml) | 6 months |
| D-dimers (ng/ml) | cohortes "T" and "Px" only | 1 months |
| D-dimers (ng/ml) | cohortes "T" and "Px" only | 2 months |
| D-dimers (ng/ml) | cohortes "T" and "Px" only | 3 months |
| D-dimers (ng/ml) | cohortes "T" and "Px" only | 4 months |
| D-dimers (ng/ml) | cohortes "T" and "Px" only | 5 months |
| Fibrin monomers (ng/ml) | baseline |
| Fibrin monomers (ng/ml) | 6 months |
| Fibrin monomers (ng/ml) | cohortes "T" and "Px" only | 1 month |
| Fibrin monomers (ng/ml) | cohortes "T" and "Px" only | 2 months |
| Fibrin monomers (ng/ml) | cohortes "T" and "Px" only | 3 months |
| Fibrin monomers (ng/ml) | cohortes "T" and "Px" only | 4 months |
| Fibrin monomers (ng/ml) | cohortes "T" and "Px" only | 5 months |
| creatininemia (µM/L) | baseline |
| creatininemia (µM/L) | 6 months |
| blood Glutamo-oxaloacetate transaminase (UI/L) | baseline |
| blood Glutamo-oxaloacetate transaminase (UI/L) | 6 months |
| blood glutamo-pyruvate transaminase (UI/L) | baseline |
| blood glutamo-pyruvate transaminase (UI/L) | 6 months |
| blood gamma-glutamyl transaminase (UI/L) | 6 months |
| blood gamma-glutamyl transaminase (UI/L) | baseline |
| C reactive protein (mg/l) | baseline |
| C reactive protein (mg/l) | 6 months |
| blood fibrinogen (g/l) | baseline |
| blood fibrinogen (g/l) | 6 months |