NCT02488525

Brief Summary

Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3 heart-failure

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

January 20, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

2.6 years

First QC Date

July 1, 2015

Last Update Submit

July 9, 2019

Conditions

Heart Failure

Keywords

Acquired Von WillebrandGastro-intestinal bleedingLVAD

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with clinically significant bleeding within 3 months after implantation

    A clinically significant bleeding event is defined as internal or external bleeding leading to death or prolonged hospitalization or requiring re-hospitalization, surgery or transfusion of at least 3 units of packed red blood cells or hemoglobin drop\> 3g/dL and/or refractory to conventional approach

    3 months

Study Arms (2)

Wilfactin

EXPERIMENTAL

Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.

Drug: Prophylactic treatment with Wilfactin

Control

NO INTERVENTION

The control group will receive all treatments according to standard of care which does not include prophylactic administration of Wilfactin®

Interventions

Prophylactic treatment with WilfactinDRUG

Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.

Also known as: Prophylactic treatment with VWF factor concentrate
Wilfactin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \> 18 years who need a CF-LVAD due to advanced heart failure.
  • Functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time \>180 sec and or VWF:Act/VWF:Ag≤ 0.7)
  • Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)

You may not qualify if:

  • Treatment with Wilfactin® within the last seven days
  • Previous adverse reaction to Wilfactin®
  • Absence of functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time \>250 sec and or VWF:Act/VWF:Ag\<0.7)
  • Patient with a known thrombophilia
  • Patient with a known severe bleeding disorder
  • Patient refusal or environment
  • Minor patients
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU,

Lille, France

Location

Related Publications (2)

  • Vincentelli A, Susen S, Le Tourneau T, Six I, Fabre O, Juthier F, Bauters A, Decoene C, Goudemand J, Prat A, Jude B. Acquired von Willebrand syndrome in aortic stenosis. N Engl J Med. 2003 Jul 24;349(4):343-9. doi: 10.1056/NEJMoa022831.

    PMID: 12878741BACKGROUND

  • Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10.

    PMID: 25670067BACKGROUND

MeSH Terms

Conditions

Heart FailureGastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susen Sophie, MD, PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 2, 2015

Study Start

January 20, 2016

Primary Completion

September 5, 2018

Study Completion

September 5, 2018

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)