Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

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.

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