Von Willebrand Factor As a Biological Sensor of Blood Flow in Percutaneous Cardiac Procedure (WiTAVi)

February 8, 2017 updated by: University Hospital, Lille

Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow

The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study was designed to understand the Von Willebrand Factor (VWF) abnormalities observed in association with implantation of different devices in cardiovascular diseases (percutaneous valve replacement and circulatory support devices).

The main objective of the study was to describe the time-course of VWF abnormalities onset/offset during implantation of devices in cardiovascular diseases.

Adult patients > 18 years who need a CF-LVAD or trans-aortic valve implantation are included in this cohort; Blood samples are obtained just before procedures

Study Type

Observational

Enrollment (Anticipated)

500

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
      • Lille, France, 59037
        • Recruiting
        • Lille University Hospital
        • Contact:
        • Principal Investigator:
          • Eric van Belle, MD, PhD

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

Non-Probability Sample

Study Population

patients receiving mechanical circulatory support or undergoing aortic valve replacement

Description

Inclusion Criteria:

  • Adult patients > 18 years who need a mechanical circulatory support due to advanced heart failure or undergoing trans-aortic-valve-replacement to treat aortic stenosis.
  • Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)

Exclusion Criteria:

  • Patient with a known severe bleeding disorder
  • Patient refusal or environment
  • Minor patients
  • Pregnant women

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cardiac devices
patients receiving mechanical circulatory support patients undergoing transaortic valve replacement
Device: cardiac devices
patients receiving mechanical circulatory support or undergoing trans aortic valve replacement
Other Names:
  • trans aortic valve replacement
  • mechanical circulatory support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Von Willebrand factor (VWF) multimer defects
Time Frame: 180 minutes after device implantation
VWF multimeric analysis is performed by electrophoresis. The results of HMW-multimers are expressed as the relative amount of the largest multimers (mer>15) of the sample compared with those of the normal pooled plasma (NPP standard human plasma Siemens healthcare diagnostics, Marburg, Germany, coefficient of variation=11%) present on each gel. 4-6 With this method the HMW-multimer ratio is defined as the HMW-multimers (>15-mer) in patient plasma sample divided by HMW-multimers in normal pool plasma, the HMW-multimer ratio of normal pooled plasma is 1 (by definition) and an HMW-multimer defect is defined as a reduced HMW-multimer-ratio (<1).
180 minutes after device implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
platelet function analyser- ADP (PFA-ADP) closure time
Time Frame: 5, 15,30, 60 minutes; day 1 , day 7 after device implantation
The PFA test is initially performed with the Collagen/Epinepherine membrane. A normal Col/ADP closure time (<180 seconds) excludes the presence of a significant platelet function defect.
5, 15,30, 60 minutes; day 1 , day 7 after device implantation

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Study Chair: Sophie Susen, MD, PhD, Lille University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI_59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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