Clinical trial NCT02488525: Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
Official title: Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Acquired Von Willebrand
Gastro-intestinal bleeding
LVAD
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Laboratoire français de Fractionnement et de Biotechnologies
name: Ministry of Health, France
First posted: 2015-07-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of patients with clinically significant bleeding within 3 months after implantation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU,
Study officials:
affiliation: University Hospital, Lille
name: Susen Sophie, MD, PhD
role: STUDY_CHAIR
References:
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.
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.