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Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support (PHAM)

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Prophylactic treatment with Wilfactin
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Acquired Von Willebrand, Gastro-intestinal bleeding, LVAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • CHRU,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wilfactin

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2015
Last Updated
July 9, 2019
Sponsor
University Hospital, Lille
Collaborators
Laboratoire français de Fractionnement et de Biotechnologies, Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02488525
Brief Title
Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
Acronym
PHAM
Official Title
Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
deficient inclusion
Study Start Date
January 20, 2016 (Actual)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Laboratoire français de Fractionnement et de Biotechnologies, Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This time point was chosen because the bleeding events are maximal within the first 3 months after implantation. Adult patients > 18 years who need a CF-LVAD due to advanced heart failure. Functional To determine the potential indication of Wilfactin® in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Acquired Von Willebrand, Gastro-intestinal bleeding, LVAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wilfactin
Arm Type
Experimental
Arm Description
Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive all treatments according to standard of care which does not include prophylactic administration of Wilfactin®
Intervention Type
Drug
Intervention Name(s)
Prophylactic treatment with Wilfactin
Other Intervention Name(s)
Prophylactic treatment with VWF factor concentrate
Intervention Description
Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.
Primary Outcome Measure Information:
Title
Percentage of patients with clinically significant bleeding within 3 months after implantation
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susen Sophie, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Study Chair
Facility Information:
Facility Name
CHRU,
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12878741
Citation
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.
Results Reference
background
PubMed Identifier
25670067
Citation
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.
Results Reference
background

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Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

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