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

Sponsor
University Hospital, Lille (Other)
Overall Status
Unknown status
CT.gov ID
NCT02628509
Collaborator
(none)
500
Enrollment
1
Location
65
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: cardiac devices

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow
Actual Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Von Willebrand factor (VWF) multimer defects [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).

    Secondary Outcome Measures

    1. platelet function analyser- ADP (PFA-ADP) closure time [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lille University Hospital Lille France 59037

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT02628509
    Other Study ID Numbers:
    • NI_59
    First Posted:
    Dec 11, 2015
    Last Update Posted:
    Feb 9, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University Hospital, Lille
    Acquired Von Willebrand
    Trans aortic valve replacement
    mechanical circulatory support
    Additional relevant MeSH terms:
    Aortic Valve Stenosis

    Study Results

    No Results Posted as of Feb 9, 2017