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Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

NCT03966313 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2025-03-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2024-04-13
Completion
2024-04-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966313 on ClinicalTrials.gov