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

April 21, 2020 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Hopitaux Universitaire de Strasbourg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with end-stage heart failure (acute or chronic) under surgery for implantation of a ventricular assist device.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Von Willebrand Factor activity
Time Frame: From Baseline to 48 hours
Change of Von Willebrand Factor from Baseline to 48 hours
From Baseline to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 21, 2019

Primary Completion (ANTICIPATED)

June 21, 2022

Study Completion (ANTICIPATED)

June 21, 2022

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (ACTUAL)

May 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7287

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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