Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

• Status: Terminated
• Trial end date: 2018-09-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborators: Laboratoire français de Fractionnement et de Biotechnologies; Ministry of Health, France

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