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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.
CHRU,
Lille, France
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
Time frame: 3 months
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