Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation (HemostVAD)

University Hospital, Strasbourg, France

Status: Terminated

Conditions: End-stage Heart Failure

Treatments: Device: ventricular assist device implantation

Study type: Observational

Funder types: Other

Identifiers

NCT03966313

7287

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Preoperative anemia less than 7 g/dL
• Subject under the protection of justice
• Subject under guardianship or curatorship
• Pregnancy
• Breastfeeding