Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Von Willebrand Factor activity
研究概览
简要总结
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.
The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.
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
- 否
入选标准
- •Age over 18 years old
- •Who gave his consent to the study
- •With an end-stage heart-failure
- •Under surgery for a ventricular assist device implantation
- •Scheduled or in emergency
排除标准
- •Preoperative anemia less than 7 g/dL
- •Subject under the protection of justice
- •Subject under guardianship or curatorship
- •Pregnancy
- •Breastfeeding
结局指标
主要结局
Von Willebrand Factor activity
时间窗: From Baseline to 48 hours
Change of Von Willebrand Factor from Baseline to 48 hours
次要结局
未报告次要终点
