NCT02488525

Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Prophylactic 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.

Timeline

• Start date: 2016-01-20
• Primary completion: 2018-09-05
• Completion: 2018-09-05
• First posted: 2015-07-02
• Last updated: 2019-07-11

Locations

1 site across 1 country: France