Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy
概览
简要总结
Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.
An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).
The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.
Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).
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
- •person who has given oral consent
- •blood donor at EFS Bourgogne Franche-Comté
- •or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon
- •or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital
排除标准
- •a person who is not affiliated to or not a beneficiary of national health insurance
- •person subject to court-ordered protection (curatorship, guardianship)
- •pregnant, parturient or breastfeeding woman
- •a person who is unable to consent
- •person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)
结局指标
主要结局
Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy
时间窗: Baseline
Repeatability and reproducibility of the result in controls
时间窗: Baseline
次要结局
未报告次要终点