NCT03966313

Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• End-stage Heart Failure

Interventions

Type	Name	Description
DEVICE	ventricular assist device implantation	Blood sampling in patients under surgery for ventricular assist device implantation at five time points: * After anesthetic induction * Before starting the device * 2h, 6h and 48h after starting the device

Timeline

• Start date: 2019-06-21
• Primary completion: 2024-04-13
• Completion: 2024-04-13
• First posted: 2019-05-29
• Last updated: 2025-03-25

Locations

1 site across 1 country: France