Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Plasma free DNA concentration (ng/ml)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Plasma free DNA concentration (ng/ml)
时间窗: 5 months
For cohortes T and Px
Plasma nucleosome concentration (ng/ml)
时间窗: 5 months
For cohortes T and Px
次要结局
- D-dimers (ng/ml)(5 months)
- Fibrin monomers (ng/ml)(5 months)
- creatininemia (µM/L)(6 months)
- blood Glutamo-oxaloacetate transaminase (UI/L)(6 months)
- blood gamma-glutamyl transaminase (UI/L)(baseline)
- C reactive protein (mg/l)(6 months)
- blood fibrinogen (g/l)(6 months)
- Hemogram(5 months)
- blood glutamo-pyruvate transaminase (UI/L)(6 months)