Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-21

Study Completion Date

2024-04-13

Brief Summary

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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.

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Detailed Description

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Conditions

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End-stage Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No