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Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03966313
Acronym
HemostVAD
Enrollment
26
Registered
2019-05-29
Start date
2019-06-21
Completion date
2024-04-13
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Heart Failure

Brief 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.

Interventions

DEVICEventricular 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

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Von Willebrand Factor activityFrom Baseline to 48 hoursChange of Von Willebrand Factor from Baseline to 48 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026