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临床试验/NCT03966313
NCT03966313终止不适用

Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年6月21日最近更新:
适应症

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

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

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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