NCT04483245已完成不适用
Platelet Activation by a Collagen Analogue in Hemorrhagic Situations
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B.
研究概览
简要总结
Dijon University Hospital and the Dijon-based NVH Medicinal Company have developed a recombinant mini-collagen NVH020B with platelet and Willebrand factor binding activity. Its small size and granular, non-fibrillar presentation make it suitable for use as an injectable hemostat in patients with a hemorrhage or other emergency under antiplatelet therapy.
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 their non-opposition to inclusion
- •Healthy volunteers or controls (patients seen in consultation, without history of hemmorhage, etc.).
- •patients with acute bleeding: polytraumatized, or hemorrhage or intracerebral haemorrhage, or bleeding complications at the end surgery (in particular cardiac surgery with ECMO) or
- •patients with antiplatelet therapy or
- •patients with thrombocytopenia/thrombopathy
排除标准
- •protected adults (curatorship, guardianship)
- •person deprived of their liberty by judicial or administrative decision
- •pregnant, parturient or breastfeeding woman
- •person unable to express their non-opposition
- •platelet transfusion on initial management
结局指标
主要结局
The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B.
时间窗: Through study completion, an average of 1 year
These 2 markers are absent on the surface of resting platelets. The expression of these 2 markers will make it possible to evaluate the role of the mini-collagen as an activator.
次要结局
- Platelet aggregation rate in response to NVH020B(Through study completion, an average of 1 year)
研究者
研究点 (1)
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