Heart Failure
Conditions
Keywords
Acquired Von Willebrand, Gastro-intestinal bleeding, LVAD
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.
Interventions
DRUGProphylactic treatment with Wilfactin
Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.
Sponsors
Laboratoire français de Fractionnement et de Biotechnologies
Ministry of Health, France
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with clinically significant bleeding within 3 months after implantation | 3 months | 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 |
Countries
France
Outcome results
None listed