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Clinical Trials/NCT03966313
NCT03966313
Terminated
N/A

Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

University Hospital, Strasbourg, France1 site in 1 country26 target enrollmentJune 21, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
End-stage Heart Failure
Sponsor
University Hospital, Strasbourg, France
Enrollment
26
Locations
1
Primary Endpoint
Von Willebrand Factor activity
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 21, 2019
End Date
April 13, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Von Willebrand Factor activity

Time Frame: From Baseline to 48 hours

Change of Von Willebrand Factor from Baseline to 48 hours

Study Sites (1)

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